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Treatment of Mania Symptoms With Drug Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patricia Suppes, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183443
First received: September 13, 2005
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
Schizophrenia
Drug: Divalproex-extended release (DVP-ER)
Drug: Lithium
Drug: Quetiapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Divalproex Extended Release and Placebo, Lithium, or Quetiapine for Mania

Resource links provided by NLM:


Further study details as provided by Palo Alto Institute for Research and Education, Inc:

Primary Outcome Measures:
  • Reduction in symptoms of mania, as measured by Young Mania Rating Scale [ Time Frame: Measured at baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: Measured at baseline and Week 12 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale [ Time Frame: Measured at baseline and Week 12 ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning [ Time Frame: Measured at baseline and Week 12 ] [ Designated as safety issue: No ]
  • Lehman Quality of Life scale [ Time Frame: Measured at baseline and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: February 2005
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: DVP + placebo
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Drug: Divalproex-extended release (DVP-ER)
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.
Other Name: depakote ER
Active Comparator: DVP + Quetiapine
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Drug: Divalproex-extended release (DVP-ER)
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.
Other Name: depakote ER
Drug: Quetiapine
Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
Other Name: Seroquel
Active Comparator: DVP + Lithium
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Drug: Divalproex-extended release (DVP-ER)
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.
Other Name: depakote ER
Drug: Lithium
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.
Other Name: Lithobid

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183443

Locations
United States, California
Stanford School of Medicine and VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Palo Alto Institute for Research and Education, Inc
Investigators
Principal Investigator: Trisha Suppes, MD, PhD Stanford School of Medicine and VA Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: Patricia Suppes, Director, Bipolar and Depression Research Program, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00183443     History of Changes
Other Study ID Numbers: R01 MH069801, R01MH069801, DSIR 83-ATSO
Study First Received: September 13, 2005
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Palo Alto Institute for Research and Education, Inc:
Mania
Manic-depressive
Psychotic disorder

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Lithium
Lithium Carbonate
Quetiapine
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 23, 2014