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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00183469 |
Purpose
This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Depression |
Drug: Lamotrigine (LAM) Drug: Divalproex (DIV) Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination |
| Estimated Enrollment: | 170 |
| Study Start Date: | December 2004 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Participants will take active lamotrigine and active divalproex
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Drug: Lamotrigine (LAM)
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)
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.
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2: Placebo Comparator
Participants will take active lamotrigine and placebo
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Drug: Lamotrigine (LAM)
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: Placebo
During the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fasion.
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Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.
Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Department of Psychiatry, University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: | Charles L. Bowden, MD | 210-567-5405 |
More Information
| Responsible Party: | University of Texas Health Science Center at SanAntonio ( Charles L. Bowden ) |
| Study ID Numbers: | P20 MH68662, DSIR 83-ATSO |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00183469 History of Changes |
| Health Authority: | United States: Federal Government |
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Lamotrigine Divalproex Antidepressant |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Calcium Channel Blockers Valproic Acid Membrane Transport Modulators Affective Disorders, Psychotic Mental Disorders Therapeutic Uses Tranquilizing Agents Depression Bipolar Disorder |
Central Nervous System Depressants Enzyme Inhibitors Cardiovascular Agents Antimanic Agents Depressive Disorder Pharmacologic Actions Behavioral Symptoms Lamotrigine Mood Disorders GABA Agents Central Nervous System Agents Anticonvulsants |
