Treatment of Mania Symptoms With Drug Therapy
Condition: Bipolar Disorder; Schizophrenia
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

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 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 comprise a 12-week acute phase and a 14-week continuation phase. While the
      acute phase is the primary component of this study, the continuation phase will provide
      extended data on the characteristics and course of responders to the initial treatment
      combinations. Results from the continuation phase will be reported elsewhere. In the acute
      phase, 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 the acute phase; biweekly study visits will occur for
      the following 8 weeks. After the acute phase, 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 offered enrollment in the 14-week
      continuation phase, during which time participants will continue the drug regimen they began
      in the acute phase. Participants will have biweekly study visits in the continuation phase.
      During each study visit in both phases, 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 the acute phase, and at the end of the
      continuation phase. Participants over 50 years of age will have an electrocardiogram (EKG) at
      study entry to determine cardiac function.
    

Intervention name(s): Divalproex-extended release (DVP-ER); Lithium; Quetiapine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.; Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.; Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
Other intervention name(s): depakote ER; Lithobid; Seroquel
Intervention MeSH terms: Valproic Acid; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mania; Manic-depressive; Psychotic disorder