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OpenTrials
Completed

NCT Number: NCT00051298

Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia

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 schizophrenia in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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., Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are male or female patients, 13 to 17 years of age
  • Patients must have a diagnosis of schizophrenia per DSM-IV-TR.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment.
  • 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.
  • Patients must be capable of swallowing study medication whole (without crushing, dissolving, etc.)

Exclusion criteria

  • Female patients who are either pregnant or nursing.
  • Patients with acute or unstable medical conditions.
  • Patients who have been judged clinically to be at serious suicidal risks.
  • Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
  • Patients who currently have delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder or major depressive disorder.

Treatment and study plan

Olanzapine

Drug

Placebo

Drug

Primary outcomes

  1. Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C

Secondary outcomes

  1. Assess secondary efficacy measures to capture additional evidence of efficacy utilizing the CGI-I, CGI-S, PANSS and OAS

  2. Assess the efficacy of olanzapine compared with placebo in improving clinical symptomatology in terms of rate of response

  3. Assess the safety of olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.

  4. Assess the health-related quality of life and cognition associated with olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for 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
Jan 9, 2003
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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