Trial intelligence / Profile preview

Olanzapine/Fluoxetine vs Lamotrigine in Bipolar I Depression

NCT00485771Phase 4

Key facts

Status: Completed
Start: Nov 2003
Countries: 1
Sponsor: Eli Lilly and Company
Modality: Small Molecules

Drugs: olanzapinefluoxetine
Conditions: bipolar I disorder

Overview

Phase 4, randomised, double-blind trial of olanzapine and fluoxetine in bipolar I disorder (2 arms), sponsored by Eli Lilly and Company. Primary endpoint: Clinical Global Impressions-Severity of Illness at 7 weeks. Started Nov 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Olanzapine/Fluoxetine
Olanzapine/Fluoxetine Combination (OFC)
Lamotrigine
Lamotrigine monotherapy

Who it enrols

Patients 18-60 years old with Bipolar I Depression, having experienced at least one previous manic/mixed episode. Excludes patients with other psychotic disorders, recent clozapine or ECT use, or seizure disorders.

Endpoints

Primary

Clinical Global Impressions-Severity of Illness7 weeks

Secondary

Montgomery-Asberg Depression Rating Scale7 weeks
Response Rate7 weeks
Remission Rate7 weeks
Relapse Rate6 months
Young Mania Rating Scale7 weeks
Safety and Tolerability6 months

Beyond the preview

Go deeper on NCT00485771.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00485771.