Treatment of Mania Symptoms With Drug Therapy

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palo Alto Veterans Institute for Research
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Lithium Carbonate; Quetiapine Fumarate; Valproic Acid

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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