Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00034580

Enrollment

326

Registered

2002-05-01

Start date

2001-08-31

Completion date

2002-08-31

Last updated

2006-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar I Disorder

Brief summary

This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.

Interventions

DRUGolanzapine

DRUGrisperidone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male or female subject, 18-70 years of age * Female subjects of childbearing potential must be using a medically accepted means of contraception * Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol * Subjects must be considered reliable Exclusion: * Female subjects who are either pregnant or nursing * Uncorrected hypothyroidism or hyperthyroidism * Narrow-angle glaucoma * Subjects who present a serious and immediate risk of endangering him or herself

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026