Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effectiveness of two different mood stabilizing medications, lithium and valproate, in treating people with bipolar disorder and suicidal behavior.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Lithium Carbonate; Valproic Acid

Criteria

Inclusion Criteria:

• Current major depressive episode or mixed episode

• Bipolar disorder

• History of suicidal behavior

Exclusion Criteria:

• Requires detoxification from alcohol or other substances

• Blood pressure greater than 160/90 mm Hg

• Active medical problems

• Requires long-term antipsychotic maintenance

• Becomes manic on mood stabilizers and antidepressants

• Contraindication to the use of lithium 1 or valproate (including failure to respond)

• Failure to respond to adequate trials of paroxetine, bupropion, and venlafaxine in the 2 years prior to study entry

• Failure to respond to adequate trials of olanzapine, haloperidol, and perphenazine in the 2 years prior to study entry

• Unable or unwilling to consent to treatment

• Pregnant or lactating