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

Completed · Phase 1

Conditions studied: Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00563992

Run by

New York State Psychiatric Institute

People needed

98

Starts

2001-01-01

Expected to finish

2008-10-01

Last updated by the study team

2012-05-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current major depressive episode or mixed episode
• Bipolar disorder
• History of suicidal behavior

You may not qualify if…

• 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

Where it is running

• New York State Psychiatric Institute/Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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