Trial intelligence / Profile preview

Olanzapine in adolescents with bipolar mania

NCT00050206Phase 4

Key facts

Status: Completed
Start: Nov 2002
Countries: 1
Sponsor: Eli Lilly and Company
Modality: Small Molecules

Drugs: olanzapine
Conditions: bipolar I disorder

Overview

Phase 4, randomised, double-blind trial in bipolar I disorder comparing Olanzapine with Placebo (2 arms). Primary endpoint: Young Mania Rating Scale at 3 weeks. Started Nov 2002; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Olanzapine
Olanzapine flexible dose
Placebo
Placebo

Who it enrols

Adolescents (13-17 years) with Bipolar I Disorder currently displaying an acute mania or mixed episode. Excludes pregnant/nursing females, those with schizophrenia/schizoaffective disorder, unstable medical conditions, serious suicidal risk, or prior non-response to olanzapine.

Endpoints

Primary

Young Mania Rating Scale3 weeks

Secondary

Clinical Global Impressions-Bipolar Version3 weeks
Children's Depression Rating Scale-Revised3 weeks
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV3 weeks
Overt Aggression Scale3 weeks
Safety and Quality of Life29 weeks
Frequency of Response29 weeks

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