Trial Outcomes & Findings for A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression (NCT NCT00376220)
NCT ID: NCT00376220
Last Updated: 2017-04-11
Results Overview
The Montgomery Asberg Depression Rating Scale measures symptoms of depression (MADRS) is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions with a fixed 7 point scale (0-6). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response will be defined as a \> 50% reduction in MADRS score from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
Active Treatment Group
Riluzole: Initially dispensed 50 mg capsules to take twice daily (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID \[two capsules in the morning (qAM), two capsules in the evening (qHS)\]. If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
|
Inactive/ Placebo Group
Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
|
Overall Study
COMPLETED
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Active Treatment Group
Riluzole: Initially dispensed 50 mg capsules to take twice daily (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID \[two capsules in the morning (qAM), two capsules in the evening (qHS)\]. If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
|
Inactive/ Placebo Group
Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression
Baseline characteristics by cohort
| Measure |
Active Treatment Group
n=47 Participants
Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
|
Inactive/Placebo Group
n=47 Participants
Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 10 • n=99 Participants
|
43 years
STANDARD_DEVIATION 11 • n=107 Participants
|
43 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=99 Participants
|
47 participants
n=107 Participants
|
94 participants
n=206 Participants
|
|
Montgomery Asberg Depression Rating scale (MADRS)
|
32.4 units on a scale
STANDARD_DEVIATION 6.7 • n=99 Participants
|
30.4 units on a scale
STANDARD_DEVIATION 6.0 • n=107 Participants
|
31.4 units on a scale
STANDARD_DEVIATION 6.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.
The Montgomery Asberg Depression Rating Scale measures symptoms of depression (MADRS) is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions with a fixed 7 point scale (0-6). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response will be defined as a \> 50% reduction in MADRS score from baseline.
Outcome measures
| Measure |
Active Treatment Group
n=47 Participants
Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
|
Inactive/Placebo Group
n=47 Participants
Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS \< 12) the dose will not be increased further unless clinical symptoms recur.
|
|---|---|---|
|
Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy.
Baseline MADRS
|
32.4 units on a scale
Standard Deviation 1.0
|
30.4 units on a scale
Standard Deviation 0.9
|
|
Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy.
Week 8
|
21.7 units on a scale
Standard Deviation 1.8
|
19.0 units on a scale
Standard Deviation 2
|
Adverse Events
Active Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inactive/Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer L. Payne M.D.
Johns Hopkins University School of Medicine
Phone: 410-502-0050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place