Status:
COMPLETED
Treatment of Mania Symptoms With Drug Therapy
Lead Sponsor:
Palo Alto Veterans Institute for Research
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania.
Detailed Description
Mania is a serious condition characterized by extreme excitement, mental and physical hyperactivity, insomnia, and disconnected thoughts. Symptoms of mania are common in patients with schizophrenia or...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00183443
Start Date
February 1 2005
End Date
November 1 2010
Last Update
July 17 2018
Active Locations (1)
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1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304