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

Bipolar I Disorder Clinical Trial

Official title:

An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195780
• Other study ID #: M03-647
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: June 29, 2007
• Start date: February 2005

Study information

• Verified date: June 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Subject is between 10 and 17 years of age, inclusive, on Day 1 and weighs at least 60 lbs (27 kg).

• Subject has a current psychiatric diagnosis of bipolar I disorder, manic or mixed episode, based on the K-SAD-PL interview and DSM-IV-TR criteria.

• Subject is an outpatient in a manic or mixed episode with a YMRS score of greater than or equal to 16 during Screening and at Day 1.

Exclusion Criteria:

• Has an Axis I disorder other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder, Enuresis, Encopresis, Parasomnias, Agoraphobia, Specific Phobia, Social Phobia or Separation Anxiety Disorder; or subject has an Axis II disorder that would interfere with the subject's ability to comply with study procedures or confound interpretation of the study results. Subject meets DSM-IV-TR criteria for substance abuse within the month prior to Screening, or meets the criteria for substance dependence within the three months prior to Screening, or exhibits signs of drug or alcohol intoxication or withdrawal at Day 1.

• Is expected to require hospitalization for the current manic or mixed episode.

• Is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others.

• Has a history of a chronic or acute medical disorder that, in the opinion of the investigator, would preclude compliance with the protocol, or confound interpretation of the study results.

• Has a history of, or is suspected of having a seizure disorder.

• Has any central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease.

• Has Platelet count less than or equal to 100,000/µL

• Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening.

• Is taking a protocol allowed medication for ADHD that has not been stable for at least 3 months prior to Day 1, or that, in the investigator's opinion, may be exacerbating mood symptoms.

• Requires anticoagulant drug therapy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• Divalproex Sodium (Depakote ER)

Locations

Country	Name	City	State
United States	Clinical Trials Specialists	Bala Cynwyd	Pennsylvania
United States	Pharmasite Research	Baltimore	Maryland
United States	Acadia Hospital	Bangor	Maine
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neuro Behavioral Clinical Research, INC.	Canton	Ohio
United States	North Carolina Neuropsychiatry, PA	Chapel Hill	North Carolina
United States	Psychiatric Professional Services	Cincinnati	Ohio
United States	Northlake Medical Research Center	Decatur	Georgia
United States	InSite Clinical Research	DeSoto	Texas
United States	Mountain West Clinical Trials	Eagle	Idaho
United States	Odyssey Research	Fargo	North Dakota
United States	Segal Institute for Clinical Research	Ft. Lauderdale	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Red Oak Psychiatry	Houston	Texas
United States	R/D Clinical Research	Lake Jackson	Texas
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Rakesh Ranjan, M.D. & Associates, Inc.	Lyndhurst	Ohio
United States	UTHSC, Sept. of Psychiatry, College of Medicine	Memphis	Tennessee
United States	Cientifica Inc.	Newton	Kansas
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	IPS Research	Oklahoma City	Oklahoma
United States	Psychiatric Associates	Overland Park	Kansas
United States	PCSD Feighner Research	San Diego	California
United States	PCSD Feighner Research	San Marcos	California
United States	Brentwood Research Institute	Shreveport	Louisiana
United States	Clinco	Terre Haute	Indiana
United States	Kolin Research Group	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Secondary	Y-MRS
Secondary	CGI-S
Secondary	C-GAS
Secondary	CDRS-R
Secondary	CGSQ
Secondary	responders
Secondary	remitters