Treatment of Mania Symptoms With Drug Therapy

NCT00183443 | Completed Phase 3 Results DMC

• 3 other identifiers: SUP0001AGG/ADOR01MH069801DSIR 83-ATSO
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder; Schizophrenia

Keywords

Mania; Manic-depressive; Psychotic disorder

Outcome Measures

Primary Outcomes (1)

• Symptoms of Mania, as Measured by Young Mania Rating Scale

  Symptoms of mania, as measured by Young Mania Rating Scale. The scale is eleven-item multiple choice diagnostic questionnaire (range 0-60), which psychiatrists use to measure the severity of manic episodes in children and young adults. Typically, 20 is the minimum score required for mania. Higher scores represent increased severity of mania symptoms.

  Week 12

Secondary Outcomes (4)

• Hamilton Rating Scale for Depression (HAM-D,17)

  Week 12

• Clinical Global Impression Scale for Bipolar Disorder (CGI-BD)

  Week 12

• Global Assessment of Functioning

  Week 12

• Social and Occupational Functioning Assessment Scale (SOFAS)

  Week 12

Study Arms (3)

DVP + placebo

PLACEBO COMPARATOR

Participants will receive divalproex ER at a therapeutic dose, plus placebo

Drug: Divalproex-extended release (DVP-ER)

DVP + Quetiapine

ACTIVE COMPARATOR

Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg

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

DVP + Lithium

ACTIVE COMPARATOR

Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level

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

Interventions

Divalproex-extended release (DVP-ER) DRUG

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.

Also known as: depakote ER

DVP + Lithium; DVP + Quetiapine; DVP + placebo

Lithium DRUG

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.

Also known as: Lithobid

DVP + Lithium

Quetiapine DRUG

Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.

Also known as: Seroquel

DVP + Quetiapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Cosgrove VE, Allende S, Gwizdowski I, Grace Fischer E, Ostacher M, Suppes T. A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder. Int J Bipolar Disord. 2022 Mar 2;10(1):7. doi: 10.1186/s40345-022-00252-w.

  PMID: 35235061 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia; Mania; Psychotic Disorders

Interventions

Valproic Acid; Lithium; Lithium Carbonate; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Patricia Suppes
• Organization: Stanford University

tsuppes@Stanford.edu

6504935000

Study Officials

• Trisha Suppes, MD, PhD

  Stanford School of Medicine and VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bipolar and Depression Research Program

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-06

Locations

US (1)