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OpenTrials
Completed

NCT Number: NCT00182013

Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.

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Key information

Conditions

Bipolar Spectrum Disorder

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females age 6 to 18 years of age
  • Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
  • Patients must have an initial score on the Y-MRS total score of at least 15.
  • Patient must be able to participate in mandatory blood draws.
  • Patient must be able to swallow pills.

Exclusion criteria

  • Patients with chronic medical illness, DSM-IV substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study

Treatment and study plan

Risperidone

Drug

Open treatment with Risperidone

Olanzapine

Drug

Open treatment with Olanzapine

Quetiapine

Drug

Open treatment with Quetiapine

Primary outcomes

  1. Young Mania Rating Scale

    Time frame: baseline to 8 weeks

    Improvement defined as score reduction of 30% or greater.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2001
Primary completion
2004
First posted
Sep 16, 2005
Registry last updated
Jun 13, 2013

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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