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OpenTrials
Completed

NCT Number: NCT00050206

Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder

The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician.

Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
  • Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
  • Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.

Exclusion criteria

  • Female patients who are either pregnant or nursing.
  • Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
  • Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
  • Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
  • Patients who have been judged clinically to be serious suicidal risks.

Treatment and study plan

Olanzapine

Drug

Placebo

Drug

Primary outcomes

  1. Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents

Secondary outcomes

  1. Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall)

  2. Assess additional efficacy as measured by Children's Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS).

  3. Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.

  4. Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Nov 27, 2002
Registry last updated
Jun 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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