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Study Complete

A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents

Study ID:

M03-647

ClinicalTrials.gov ID:

NCT00195780

EudraCT ID:

Not Available

The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.

Reach us Online

Call us @: 844 663-3742

See Study Documents Below

Study Details

Medical Condition

Medical Condition icon
Bipolar Disorder

Study Phase

Study Phase icon
Phase 3

Intervention Type

Intervention Type icon
Interventional

Date

Date icon
Feb 2005 - N/A

Participation Requirements

Gender

Gender icon
Female & Male

Age

Age icon
10 Years - 17 Years

Healthy Volunteers

Healthy Volunteers icon
No

Inclusion Criteria

Inclusion Criteria icon

Exclusion Criteria

Exclusion Criteria icon
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Have a question?

You can ask us questions via online form or phone call.

Reach us Online

Call us @: 844 663-3742

LocationStatusSite Contact Details

The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.

  • Safety

    Time Frame: Not Available

  • Y-MRS

    Time Frame: Not Available

  • CGI-S

    Time Frame: Not Available

  • C-GAS

    Time Frame: Not Available

  • CDRS-R

    Time Frame: Not Available

  • CGSQ

    Time Frame: Not Available

  • responders

    Time Frame: Not Available

  • remitters

    Time Frame: Not Available

Interventions:

  • Drug: Divalproex Sodium (Depakote ER)

Enrollment:

227

Available Documents
FaFilePdfScientific Result Summary (English)
Additional Information

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