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Maintenance Treatment of Bipolar Depression

NCT00183469 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2017-05-17

Study results available
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Summary

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

Conditions

Interventions

DRUG

Lamotrigine

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.

DRUG

Divalproex (DIV) ER

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Charles L. Bowden, MD · 210-567-5405

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2009-02-28
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00183469 on ClinicalTrials.gov