Trial Outcomes & Findings for Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder. (NCT NCT00958633)
NCT ID: NCT00958633
Last Updated: 2025-05-15
Results Overview
The primary outcome, assessed in a time-to-event analysis, was any mood episode, defined as any of the following: a Young Mania Rating Scale (YMRS) score of at least 16 (mild mania), a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 (moderate depression), a Clinical Global Impressions Scale, Bipolar Version, Severity (CGI-S-BD) score of at least 4 for mania or depression (moderately ill), hospitalization for mood symptoms, necessity of additional pharmacotherapy for emerging mood symptoms, a MADRS suicide item score of at least 4 (scores range from 0 to 6, with higher scores indicating greater suicide risk), or a suicide attempt or suicide death. Young Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes. Clinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
237 participants
Primary outcome timeframe
52 weeks
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
8 Week Arm
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:
Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.
Escitalopram 10 - 30 mg daily or Bupropion XL 150 - 450 mg daily
* In patients randomized to the "8-week group", escitalopram/bupropion will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit.
|
52 Week Arm
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg
|
Open-Label Phase (up to 16 Weeks)
Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.
|
|---|---|---|---|
|
Open-Label (up to 16 Weeks)
STARTED
|
0
|
0
|
209
|
|
Open-Label (up to 16 Weeks)
COMPLETED
|
0
|
0
|
150
|
|
Open-Label (up to 16 Weeks)
NOT COMPLETED
|
0
|
0
|
59
|
|
Double-Blind Phase (up to 52 Weeks)
STARTED
|
88
|
90
|
0
|
|
Double-Blind Phase (up to 52 Weeks)
COMPLETED
|
87
|
90
|
0
|
|
Double-Blind Phase (up to 52 Weeks)
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
8 Week Arm
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:
Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.
Escitalopram 10 - 30 mg daily or Bupropion XL 150 - 450 mg daily
* In patients randomized to the "8-week group", escitalopram/bupropion will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit.
|
52 Week Arm
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg
|
Open-Label Phase (up to 16 Weeks)
Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.
|
|---|---|---|---|
|
Open-Label (up to 16 Weeks)
Lost to Follow-up
|
0
|
0
|
14
|
|
Open-Label (up to 16 Weeks)
Withdrawal by Subject
|
0
|
0
|
18
|
|
Open-Label (up to 16 Weeks)
Worsening of symptoms
|
0
|
0
|
13
|
|
Open-Label (up to 16 Weeks)
Lack of Efficacy
|
0
|
0
|
8
|
|
Open-Label (up to 16 Weeks)
Non-adherence
|
0
|
0
|
2
|
|
Open-Label (up to 16 Weeks)
Physician Decision
|
0
|
0
|
4
|
|
Double-Blind Phase (up to 52 Weeks)
Excluded due to missing baseline and follow-up data.
|
1
|
0
|
0
|
Baseline Characteristics
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
Baseline characteristics by cohort
| Measure |
Double-blind 8 Week Arm
n=87 Participants
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:
Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.
Escitalopram 10 - 30 mg daily or Bupropion XL 150 - 450 mg daily
|
Double-blind 52 Week Arm
n=90 Participants
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Escitalopram 10 - 30 mg daily or Bupropion XL 150 - 450 mg daily
|
Open-Label Phase (4-16 Weeks)
n=206 Participants
Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
Double-blind 8 week and 52 week arm · <=18 years
|
0 Participants
n=87 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
n=90 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
n=177 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
|
Age, Categorical
Double-blind 8 week and 52 week arm · Between 18 and 65 years
|
87 Participants
n=87 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
90 Participants
n=90 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
177 Participants
n=177 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
|
Age, Categorical
Double-blind 8 week and 52 week arm · >=65 years
|
0 Participants
n=87 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
n=90 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
n=177 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
|
Age, Categorical
Open-Label 4-16 week arm · <=18 years
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
n=206 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
n=206 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
|
Age, Categorical
Open-Label 4-16 week arm · Between 18 and 65 years
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
206 Participants
n=206 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
206 Participants
n=206 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
|
Age, Categorical
Open-Label 4-16 week arm · >=65 years
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
n=206 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
0 Participants
n=206 Participants • Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.
|
|
Age, Continuous
Double-Blind Phase
|
42.9 years
STANDARD_DEVIATION 11.1 • n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
39.3 years
STANDARD_DEVIATION 11.3 • n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
41.1 years
STANDARD_DEVIATION 11.3 • n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Age, Continuous
Open-Label Phase
|
—
|
—
|
40.1 years
STANDARD_DEVIATION 10.9 • n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
40.1 years
STANDARD_DEVIATION 10.9 • n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Sex: Female, Male
Double-blind 8 week arm · Female
|
48 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
44 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Data are being reported separately for the Open-label and Double-Blind arms.
|
92 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Sex: Female, Male
Double-blind 8 week arm · Male
|
39 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
46 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Data are being reported separately for the Open-label and Double-Blind arms.
|
85 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Sex: Female, Male
Open-Label Phase · Female
|
0 Participants
Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Data are being reported separately for the Open-label and Double-Blind arms.
|
107 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
107 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Sex: Female, Male
Open-Label Phase · Male
|
0 Participants
Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Data are being reported separately for the Open-label and Double-Blind arms.
|
99 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
99 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Race/Ethnicity, Customized
Double-Blind Phase · Asian
|
76 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
78 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
154 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Race/Ethnicity, Customized
Double-Blind Phase · Black
|
1 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
1 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Race/Ethnicity, Customized
Double-Blind Phase · White
|
10 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
11 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
21 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Race/Ethnicity, Customized
Double-Blind Phase · Other
|
0 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
1 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
1 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Race/Ethnicity, Customized
Open-Label Phase · Asian
|
—
|
—
|
176 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
176 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Race/Ethnicity, Customized
Open-Label Phase · Black
|
—
|
—
|
1 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
1 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Race/Ethnicity, Customized
Open-Label Phase · White
|
—
|
—
|
28 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
28 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Race/Ethnicity, Customized
Open-Label Phase · Other
|
—
|
—
|
1 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
1 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Montgomery Asberg Depression Rating Scale Score
Double-Blind Phase
|
3.2 units on a scale
STANDARD_DEVIATION 2.0 • n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
3.1 units on a scale
STANDARD_DEVIATION 2.5 • n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
3.2 units on a scale
STANDARD_DEVIATION 2.3 • n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Montgomery Asberg Depression Rating Scale Score
Open-Label Phase
|
—
|
—
|
26.6 units on a scale
STANDARD_DEVIATION 4.9 • n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
26.6 units on a scale
STANDARD_DEVIATION 4.9 • n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Double-Blind Phase · Bupropion XL plus Mood Stabilizer
|
17 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
16 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
33 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Double-Blind Phase · Bupropion XL plus Mood Stabilizer plus SGA
|
14 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
16 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
30 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Double-Blind Phase · Bupropion XL plus SGA
|
1 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
3 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
4 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Double-Blind Phase · Escitalopram plus Mood Stabilizer
|
24 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
24 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
48 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Double-Blind Phase · Escitalopram plus Mood Stabilizer plus SGA
|
27 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
27 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
54 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Double-Blind Phase · Escitalopram plus SGA
|
4 Participants
n=87 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
4 Participants
n=90 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
—
|
8 Participants
n=177 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Open-Label Phase · Bupropion XL plus Mood Stabilizer
|
—
|
—
|
35 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
35 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Open-Label Phase · Bupropion XL plus Mood Stabilizer plus SGA
|
—
|
—
|
33 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
33 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Open-Label Phase · Bupropion XL plus SGA
|
—
|
—
|
7 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
7 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Open-Label Phase · Escitalopram plus Mood Stabilizer
|
—
|
—
|
53 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
53 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Open-Label Phase · Escitalopram plus Mood Stabilizer plus SGA
|
—
|
—
|
64 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
64 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Drug Combination - No.
Open-Label Phase · Escitalopram plus SGA
|
—
|
—
|
14 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
14 Participants
n=206 Participants • Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Region of Enrollment, Customized
Double-Blind Phase · Canada
|
10 Participants
n=87 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
12 Participants
n=90 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
22 Participants
n=177 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Region of Enrollment, Customized
Double-Blind Phase · India
|
76 Participants
n=87 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
76 Participants
n=90 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
152 Participants
n=177 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Region of Enrollment, Customized
Double-Blind Phase · South Korea
|
1 Participants
n=87 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
2 Participants
n=90 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
3 Participants
n=177 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Region of Enrollment, Customized
Open-Label Phase · Canada
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
29 Participants
n=206 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
29 Participants
n=206 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Region of Enrollment, Customized
Open-Label Phase · India
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
168 Participants
n=206 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
168 Participants
n=206 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
|
Region of Enrollment, Customized
Open-Label Phase · South Korea
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
0 Participants
Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
9 Participants
n=206 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
9 Participants
n=206 Participants • Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.
|
PRIMARY outcome
Timeframe: 52 weeksThe primary outcome, assessed in a time-to-event analysis, was any mood episode, defined as any of the following: a Young Mania Rating Scale (YMRS) score of at least 16 (mild mania), a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 (moderate depression), a Clinical Global Impressions Scale, Bipolar Version, Severity (CGI-S-BD) score of at least 4 for mania or depression (moderately ill), hospitalization for mood symptoms, necessity of additional pharmacotherapy for emerging mood symptoms, a MADRS suicide item score of at least 4 (scores range from 0 to 6, with higher scores indicating greater suicide risk), or a suicide attempt or suicide death. Young Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes. Clinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.
Outcome measures
| Measure |
8 Week Arm
n=87 Participants
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:
Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.
Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg
|
52 Week Arm
n=90 Participants
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg
|
|---|---|---|
|
Double-Blind Phase: Number of Participants With an Occurrence of Any Mood Episode (Manic, Hypo-manic, Depressive) During the 52 Week Study Period.
|
40 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Of the total 178 patients who underwent randomization, 1 had missing data for baseline and post baseline visits and was excluded from the analysis. Thus, the primary analysis included 177 patients, of whom 90 were assigned to the 52-week group and 87 to the 8-week group.
Time to a depressive episode, a manic or hypomanic episode, discontinuation from the trial for any clinical reason (e.g., occurrence of a mood event, withdrawal of informed consent, or adverse event), any mood episode or subsyndromal symptoms, time spent in these episodes, and scores on the CGI-BD, YMRS, and MADRS clinical rating scales. Young Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes. Clinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.
Outcome measures
| Measure |
8 Week Arm
n=87 Participants
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:
Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.
Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg
|
52 Week Arm
n=90 Participants
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Escitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg
|
|---|---|---|
|
Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.
Manic or hypomanic events
|
5 Participants
|
11 Participants
|
|
Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.
Depressive events
|
35 Participants
|
15 Participants
|
|
Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.
Mixed episode
|
0 Participants
|
2 Participants
|
|
Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.
Subsyndromal depressive symptoms
|
8 Participants
|
8 Participants
|
|
Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.
Subsyndromal manic symptoms
|
0 Participants
|
0 Participants
|
Adverse Events
8 Week Arm
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
52 Week Arm
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Open-Label Phase (4-16 Weeks)
Serious events: 1 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
8 Week Arm
n=87 participants at risk
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:
Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.
Escitalopram 10 - 30 mg or Wellbutrin XL 150 - 450 mg
|
52 Week Arm
n=90 participants at risk
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Escitalopram 10 - 30 mg or Wellbutrin XL 150 - 450 mg
|
Open-Label Phase (4-16 Weeks)
n=206 participants at risk
Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission.
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization due to discontinuation of treatment, alcohol and drug use
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.49%
1/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
Other adverse events
| Measure |
8 Week Arm
n=87 participants at risk
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:
Group 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.
Escitalopram 10 - 30 mg or Wellbutrin XL 150 - 450 mg
|
52 Week Arm
n=90 participants at risk
During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:
Group 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.
Escitalopram 10 - 30 mg or Wellbutrin XL 150 - 450 mg
|
Open-Label Phase (4-16 Weeks)
n=206 participants at risk
Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.1%
1/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.49%
1/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Gastrointestinal disorders
Abdominal pain or bloating
|
8.0%
7/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
11.1%
10/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.9%
6/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.1%
1/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.1%
1/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.1%
1/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.49%
1/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Decreased sex drive
|
16.1%
14/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
13.3%
12/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
3.4%
7/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Decreased sleep
|
1.1%
1/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.2%
2/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.49%
1/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Dizziness
|
8.0%
7/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.2%
2/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.97%
2/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Feeling faint
|
1.1%
1/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.2%
2/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.49%
1/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Fatigue or tiredness
|
14.9%
13/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
20.0%
18/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
5.8%
12/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Headache
|
2.3%
2/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.2%
2/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.5%
3/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Gastrointestinal disorders
Heartburn
|
14.9%
13/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
8.9%
8/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.4%
5/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.1%
1/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Increased sex drive
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
4.4%
4/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Insomnia
|
12.6%
11/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
10.0%
9/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.9%
6/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Psychiatric disorders
Irritability
|
2.3%
2/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
4.4%
4/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Memory problems
|
8.0%
7/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
15.6%
14/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
7.3%
15/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
1.1%
1/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.2%
2/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
2/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
5.6%
5/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.9%
4/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Psychiatric disorders
Palpitations
|
11.5%
10/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
8.9%
8/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.4%
5/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Psychiatric disorders
Poor concentration
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.1%
1/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Sleep disturbance
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
2.2%
2/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Nervous system disorders
Tremor
|
4.6%
4/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
6.7%
6/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.9%
4/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Endocrine disorders
Weight gain ≥7%
|
6.9%
6/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
14.4%
13/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.97%
2/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
General disorders
Other
|
9.2%
8/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
5.6%
5/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.97%
2/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.5%
3/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Psychiatric disorders
Mania
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
1.5%
3/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.97%
2/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
|
Investigations
Weight Gain
|
0.00%
0/87 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.00%
0/90 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
0.97%
2/206 • 4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.
The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase. The double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place