Treatment of Mania Symptoms With Drug Therapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder, Schizophrenia

In brief

This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania.

Key facts

Study ID

NCT00183443

Run by

Palo Alto Veterans Institute for Research

People needed

75

Starts

2005-02-01

Expected to finish

2010-11-01

Last updated by the study team

2018-07-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of bipolar I disorder or schizophrenia
• Experiencing symptoms of mania at study entry
• Able to speak and understand English
• Willing and able to comply with all study requirements

You may not qualify if…

• History of partial response or nonresponse to any of the drugs or drug combinations given in this study
• History of intolerance to DVP, DVP-ER, lithium, or quetiapine
• Disorders that would contraindicate the use of DV, DV-ER, lithium, or quetiapine
• Use of antidepressants within 1 month prior to study entry
• Use of fluoxetine within 3 months prior to study entry
• Impaired cardiac function, as evidenced by abnormal EKG in participants 50 or over
• Unstable medical illness within 2 months prior to study entry
• At risk for suicide
• Substance abuse or dependence within 1 month prior to study entry
• Pregnancy, breastfeeding, or plans to become pregnant during the study

Where it is running

• VA Palo Alto Health Care System — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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