Trial Outcomes & Findings for 16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression (NCT NCT02389712)
NCT ID: NCT02389712
Last Updated: 2019-06-19
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
Lamotrigine
Subjects on this arm will be randomized to Lamotrigine.
Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects.
|
Fluoxetine
Subjects on this arm will be randomized to Fluoxetine.
Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed \> 40mg.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression
Baseline characteristics by cohort
| Measure |
Lamotrigine
n=1 Participants
Subjects on this arm will be randomized to Lamotrigine.
Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects.
|
Fluoxetine
n=1 Participants
Subjects on this arm will be randomized to Fluoxetine.
Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed \> 40mg.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
n=39 Participants
|
27 years
n=41 Participants
|
27 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=39 Participants
|
1 participants
n=41 Participants
|
2 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to difficulties with recruitment
Outcome measures
Outcome data not reported
Adverse Events
Lamotrigine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluoxetine
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