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

September 13, 2005
October 8, 2013
February 2005
November 2010   (final data collection date for primary outcome measure)
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 ]
Reduction in symptoms of mania, as measured by Young Mania Rating Scale
Complete list of historical versions of study NCT00183443 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hamilton Rating Scale for Depression
  • Clinical Global Impression Scale
  • Global Assessment of Functioning
  • Lehman Quality of Life scale
Not Provided
Not Provided
 
Treatment of Mania Symptoms With Drug Therapy
Divalproex Extended Release and Placebo, Lithium, or Quetiapine for Mania

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Schizophrenia
  • 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
  • Drug: Quetiapine
    Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
    Other Name: Seroquel
  • Placebo Comparator: DVP + placebo
    Participants will receive divalproex ER at a therapeutic dose, plus placebo
    Intervention: Drug: Divalproex-extended release (DVP-ER)
  • Active Comparator: DVP + Quetiapine
    Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
    Interventions:
    • Drug: Divalproex-extended release (DVP-ER)
    • Drug: Quetiapine
  • Active Comparator: DVP + Lithium
    Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
    Interventions:
    • Drug: Divalproex-extended release (DVP-ER)
    • Drug: Lithium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183443
R01 MH069801, R01MH069801, DSIR 83-ATSO
Yes
Patricia Suppes, National Institute of Mental Health (NIMH)
Palo Alto Institute for Research and Education, Inc
National Institute of Mental Health (NIMH)
Principal Investigator: Trisha Suppes, MD, PhD Stanford School of Medicine and VA Palo Alto Health Care System
Palo Alto Institute for Research and Education, Inc
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP