Trial Outcomes & Findings for Maintenance Treatment of Bipolar Depression (NCT NCT00183469)

Last Updated: 2017-05-17

Results Overview

Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

86 participants

Primary outcome timeframe

up to 8 months

Results posted on

2017-05-17

Participant Flow

Recruitment from October 2004 to September 2007 took place in Univ of Texas Health Science Center San Antonio and Center for Healthcare services and television advertisements.

1st 8 weeks is Open Label phase. Subjects are either in a depressed episode or have been depressed in last 6 mos. In this phase subjects will take lamotrigine and divalproex ER. Those who remained depressed, or developed an episode, during 2 consecutive visits, were terminated at, or by, week 8.

Participant milestones

Participant milestones
Measure	Double-Blind Lamotrigine and Divalproex ER Double blind randomized participants will take active lamotrigine and active divalproex Er	Double-Blind Lamotrigine and Placebo Divalproex ER Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
Overall Study STARTED	41	45
Overall Study COMPLETED	13	16
Overall Study NOT COMPLETED	28	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maintenance Treatment of Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lamotrigine Plus Divalproex ER n=41 Participants Enrolled subjects received lamotrigine and divalproex ER	Lamotrigine Plus Placebo Divalproex ER n=45 Participants	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	45 Participants n=7 Participants	86 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.6 years STANDARD_DEVIATION 11.0 • n=5 Participants	42.1 years STANDARD_DEVIATION 12.7 • n=7 Participants	39.9 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	45 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 8 months

Population: all randomized subjects

Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.

Outcome measures

Outcome measures
Measure	Double-Blind Lamotrigine and Divalproex ER n=41 Participants Double blind randomized participants will take active lamotrigine and active divalproex Er	Double-Blind Lamotrigine and Placebo Divalproex ER n=45 Participants Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
Mania Rating Scale	4.54 units on a scale Standard Error .64	5.57 units on a scale Standard Error .6

Adverse Events

Lamotrigine Plus Active Divalproex ER

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lamotrigine Plus Placebo Divalproex ER

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

Charles L. Bowden, M.D. Clinical Professor

University of Texas Health Science Center San Antonio

Phone: 210 567 5405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place