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Adult Bipolar Mania

NCT00931723 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2012-04-19

Study results available
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Summary

The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).

Conditions

  • Acute Mania

Interventions

DRUG

Quetiapine fumarate XR

Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.

DRUG

Lithium

Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.

DRUG

Placebo

Oral treatment twice daily.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Michael Castiglione · AstraZeneca

  • Michel Bourin, Professeur · Neurobiologie de l'anxiété et de la dépression Faculté de Médecine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Belgium
  • Bulgaria
  • Germany
  • India
  • Israel
  • Poland
  • Russia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00931723 on ClinicalTrials.gov