Treatment of Mania Symptoms With Drug Therapy - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183443

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 III

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:

MedlinePlus related topics: Bipolar Disorder Psychotic Disorders Schizophrenia

Drug Information available for: Divalproex sodium Valproic acid Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate Valproate Sodium

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	105
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

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

National Institute of Mental Health (NIMH)

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:	Trisha Suppes, MD, PhD, Stanford Medical School and VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:	NCT00183443 History of Changes
Other Study ID Numbers:	R01 MH069801, DSIR 83-ATSO
Study First Received:	September 13, 2005
Last Updated:	July 22, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Mania
Manic-depressive
Psychotic disorder

Additional relevant MeSH terms:

Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Valproic Acid
Lithium Carbonate
Lithium
Quetiapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 12, 2012