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Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents

NCT00271258 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-01-11

No results posted yet for this study

Summary

\- Main objective: To evaluate the clinical and physiological tolerance of sodium divalproate in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6 months.

\- Secondary objective: To evaluate the efficacy of sodium divalproate in improving manic, mixed or hypomanic symptoms.

Conditions

Interventions

DRUG

SODIUM DIVALPROATE

Sponsors & Collaborators

Principal Investigators

  • Marie SEBILLE, Dr · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Completion
2007-01-31

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00271258 on ClinicalTrials.gov