CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 86 enrolled
Drug / intervention
Lamotrigine +2 moredrug
Likely dose
Lamotrigine 200 mg daily (maximum); divalproex dosed by titration to therapeutic range starting at 500 mgAI-extracted
Key inclusion· 2
  • ✓Confirmed diagnosis of bipolar disorder type I or II
  • ✓Current depressive symptoms or depressive episode within past 6 months
Key exclusion· 4
  • ✕History of liver disease
  • ✕History of substance abuse
  • ✕Prior treatment with lamotrigine or divalproex
  • ✕Known intolerance or adverse reaction to lamotrigine or divalproex

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00183469
NCT00183469Phase 4Completed
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Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination

The University of Texas Health Science Center at San Antonio·interventional·Posted Sep 16, 2005·Updated May 17, 2017

In Brief

A Phase 4 clinical trial evaluating Lamotrigine, Divalproex (DIV) ER, and 1 other intervention for Bipolar Disorder and Depression. Completed, enrolled 86 participants.

Detailed Summary

This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Depression
Countries--
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartDec 1, 2004
Primary CompletionFeb 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 20.8 years ago

Interventions

Lamotriginedrug

If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. If the participant is already taking LAM, the dose will be increased to up to 200 mg using the same guide lines. Upon randomization the participant in the placebo comparator will have their dosage titrated to doubled since the potentiating effect of the Divalproex will no longer exist. It will remain at this dosage until the end of the study with the possibility of one adjustment for side effects.

Divalproex (DIV) ERdrug

If the participant is naive to DIV and if LAM was initiated before the start of treatment with DIV, DIV can be started at any point of time in the study provided the participant has been on LAM for at least 2 weeks. DIV will be started at 500 mg and titrated by increments of 500 mg every 3 to 4 days until a therapeutic blood level is attained up to 2500 mg.

Placebodrug

During the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fashion.