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Treatment of Mania Symptoms With Drug Therapy

Information source: Palo Alto Veterans Institute for Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder; Schizophrenia

Intervention: Divalproex-extended release (DVP-ER) (Drug); Lithium (Drug); Quetiapine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Palo Alto Veterans Institute for Research

Official(s) and/or principal investigator(s):
Trisha Suppes, MD, PhD, Principal Investigator, Affiliation: Stanford School of Medicine and VA Palo Alto Health Care System

Summary

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

Clinical Details

Official title: Divalproex Extended Release and Placebo, Lithium, or Quetiapine for Mania

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction in symptoms of mania, as measured by Young Mania Rating Scale

Secondary outcome:

Hamilton Rating Scale for Depression

Clinical Global Impression Scale

Global Assessment of Functioning

Lehman Quality of Life scale

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): 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

Locations and Contacts

Stanford School of Medicine and VA Palo Alto Health Care System, Palo Alto, California 94304, United States
Additional Information

Starting date: February 2005
Last updated: October 8, 2013

Page last updated: August 23, 2015

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