MedTrace Logo

Treatment of Mania Symptoms With Drug Therapy

NCT00183443 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-07-17

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

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.

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.

DRUG

Quetiapine

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Palo Alto Veterans Institute for Research

    lead OTHER

Principal Investigators

  • Trisha Suppes, MD, PhD · Stanford School of Medicine and VA Palo Alto Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00183443 on ClinicalTrials.gov