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 bipolar disorder. When associated with these conditions, mania reaches psychotic proportions and often includes hallucinations, paranoia, and feelings of omnipotence. Such symptoms may put individuals with mania and those around them at risk for physical harm. Drug therapies that can safely and effectively treat symptoms of mania are needed. This study will compare three drug combinations in their ability to treat symptoms of mania in people with schizophrenia or bipolar I disorder.
This study will last 26 weeks and will comprise two parts. In Part 1, participants will be randomly assigned to receive one of three treatments: divalproex-extended release (DV-ER) and lithium, DV-ER and quetiapine, or DV-ER and placebo. Participants will receive their intervention for 12 weeks.
Participants will have weekly study visits for the first 4 weeks of Phase 1; biweekly study visits will occur for the following 8 weeks. After Phase 1, participants who have not responded to their drug regimen will complete their participation in the study.
Participants whose symptoms of mania have decreased will be enrolled in Phase 2. During this 14-week continuation phase, participants will continue the drug regimen they began in Phase 1. Participants will have biweekly study visits in Phase 2. During each study visit in Phases 1 and 2, participants will be interviewed about their mania symptoms. Mania, depression, quality of life, and overall functioning scales will assess participants at study entry, at the end of Phase 1, and at the end of Phase 2. Participants over 50 years of age will have an electrocardiogram (EKG) at study entry to determine cardiac function.
Ages Eligible for Study: 18 Years – 65 Years, Genders Eligible for Study: Both
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
Dorothy Kelly, MA 214-648-6963 dorothy.kelly@utsouthwestern.edu
United States, Texas
University of Texas Southwestern Medical Center, Dallas, Texas, 75390-9121, United States; Recruiting
Dorothy Kelly, MA 214-648-6920 dorothy.kelly@utsouthwestern.edu
Grace Fischer, BS 214-648-6920 grace.fischer@utsouthwestern.edu
Trisha Suppes, MD, PhD, Principal Investigator
Study chairs or principal investigators
Trisha Suppes, MD, PhD, Principal Investigator, University of Texas