Trial Outcomes & Findings for Antidepressant Therapy in Treating Bipolar Type II Major Depression (NCT NCT00602537)
NCT ID: NCT00602537
Last Updated: 2017-04-25
Results Overview
These subjects must be responders. Outcome measures were obtained at continuation weeks. Participant would be considered "depressive relapse" if relapsed by any of these times.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
Weeks 16, 20, 24, 30, 36
Results posted on
2017-04-25
Participant Flow
Participant milestones
| Measure |
Antidepressant Therapy
Venlafaxine: 75 to 375 mg
|
Mood Stabilizer Therapy
Lithium Carbonate: 300 to 2400 mg
|
|---|---|---|
|
12 Week Double Blind Comparison
STARTED
|
65
|
64
|
|
12 Week Double Blind Comparison
Responded
|
44
|
22
|
|
12 Week Double Blind Comparison
COMPLETED
|
42
|
17
|
|
12 Week Double Blind Comparison
NOT COMPLETED
|
23
|
47
|
|
Follow Up Study Comparison
STARTED
|
42
|
17
|
|
Follow Up Study Comparison
COMPLETED
|
31
|
14
|
|
Follow Up Study Comparison
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
| Measure |
Antidepressant Therapy
Venlafaxine: 75 to 375 mg
|
Mood Stabilizer Therapy
Lithium Carbonate: 300 to 2400 mg
|
|---|---|---|
|
12 Week Double Blind Comparison
Adverse Event
|
2
|
5
|
|
12 Week Double Blind Comparison
Lack of Efficacy
|
13
|
23
|
|
12 Week Double Blind Comparison
Lost to Follow-up
|
5
|
6
|
|
12 Week Double Blind Comparison
Withdrawal by Subject
|
3
|
13
|
|
Follow Up Study Comparison
Adverse Event
|
1
|
0
|
|
Follow Up Study Comparison
Lost to Follow-up
|
8
|
1
|
|
Follow Up Study Comparison
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Antidepressant Therapy in Treating Bipolar Type II Major Depression
Baseline characteristics by cohort
| Measure |
Antidepressant Therapy
n=42 Participants
Venlafaxine: 75 to 375 mg
|
Mood Stabilizer Therapy
n=17 Participants
Lithium Carbonate: 300 to 2400 mg
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
43.1 years
STANDARD_DEVIATION 15.2 • n=107 Participants
|
42.2 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
27 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
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
|
Inter-episode recovery
|
14 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age 1st major depressive episode
|
19.0 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
17.4 years
STANDARD_DEVIATION 5.4 • n=107 Participants
|
18.5 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
|
Age 1st hypomanic episode
|
20.7 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
16.2 years
STANDARD_DEVIATION 10.0 • n=107 Participants
|
19.4 years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Number of lifetime major depressive episodes
|
28.4 Episodes
STANDARD_DEVIATION 50.4 • n=99 Participants
|
33.3 Episodes
STANDARD_DEVIATION 49.7 • n=107 Participants
|
29.9 Episodes
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Number of lifetime hypomanic episodes
|
45.8 Episodes
STANDARD_DEVIATION 66.4 • n=99 Participants
|
32.2 Episodes
STANDARD_DEVIATION 47.3 • n=107 Participants
|
41.9 Episodes
STANDARD_DEVIATION 61.4 • n=206 Participants
|
|
Baseline HRSD score
|
19.4 units on a scale
STANDARD_DEVIATION 3.6 • n=99 Participants
|
18.8 units on a scale
STANDARD_DEVIATION 3.3 • n=107 Participants
|
19.2 units on a scale
STANDARD_DEVIATION 3.5 • n=206 Participants
|
|
Baseline YMRS score
|
0.8 units on a scale
STANDARD_DEVIATION 1.7 • n=99 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 1.4 • n=107 Participants
|
0.8 units on a scale
STANDARD_DEVIATION 1.6 • n=206 Participants
|
|
Duration major depressive episode
|
4.5 months
n=99 Participants
|
4.0 months
n=107 Participants
|
4 months
n=206 Participants
|
|
Baseline HRSD Score for Follow-Up study
|
4.3 units on a scale
STANDARD_DEVIATION 2.8 • n=99 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 3.4 • n=107 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 2.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 16, 20, 24, 30, 36These subjects must be responders. Outcome measures were obtained at continuation weeks. Participant would be considered "depressive relapse" if relapsed by any of these times.
Outcome measures
| Measure |
Antidepressant Therapy
n=40 Participants
Venlafaxine: 75 to 375 mg
|
Mood Stabilizer Therapy
n=15 Participants
Lithium Carbonate: 300 to 2400 mg
|
|---|---|---|
|
Depressive Relapse
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Measured at Weeks 12 and 36These subjects must be responders.
Outcome measures
| Measure |
Antidepressant Therapy
n=40 Participants
Venlafaxine: 75 to 375 mg
|
Mood Stabilizer Therapy
n=15 Participants
Lithium Carbonate: 300 to 2400 mg
|
|---|---|---|
|
Treatment-Emergent Mood Symptoms
Any depression
|
15 Participants
|
11 Participants
|
|
Treatment-Emergent Mood Symptoms
Any subsyndromal hypomania
|
3 Participants
|
3 Participants
|
Adverse Events
Antidepressant Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mood Stabilizer Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place