Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder

NCT00199966 | Completed Phase 4

• 1 other identifier: CHW 03/163, HRRC 539-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to compare how safely and how well this medicine works in treating children and teenagers between the ages of 6 and 17 years with a diagnosis of Bipolar Disorder.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Pediatric Bipolar Disorder; Depakote ER

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS), rate at baseline, Week 2,4,6,&8

Secondary Outcomes (5)

• Kiddie version of the Schedule for Affective Disorders and Schizophrenia (KSADS), assessed at baseline only.

• Child Depression Rating Scale (CDRS), rate at baseline through Week 8.

• Clinical Global Impression: Improvement and Severity (CGI), for mania, depression and ADHD. Rate from baseline through Week 8.

• Conner's Parent and Teacher Rating Scales (CRS). Rate from baseline through Week 8.

• Side Effect For Children & Adolescents (SEFCA). Rate from baseline through Week 8.

Interventions

Divalproex sodium extended release DRUG

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of Bipolar I or II confirmed by K-SADS and clinical interview.
• Ages 6 to 17 years 11 months.
• YMRS score of \<10, this is consistent with minimal symptoms of mania. Or a desire to change medications due to a simplified dosing schedule or to reduce unwanted side effects of divalproex sodium.
• Ability and willingness of subject and parent(s)/guardian(s) to provide informed written assent/consent.

You may not qualify if:

• Diagnosis of: Pervasive Developmental Disorders, Schizophrenia spectrum disorders, Obsessive Compulsive Disorder.
• Concurrent medical conditions requiring medication or that are unstable.
• Current suicidal thoughts.
• Recent suicidal behavior.
• Pregnancy or sexually active female not using a reliable form of contraception.
• Previous inadequate response to DVP ER.
• Known hypersensitivity to DVP or DVP ER.
• Recent inpatient hospitalization for suicidality or homicidality, (last 6 months).
• Subjects who are clinically stable and not suffering significant side effects on their current medical regimen.
• Use of antidepressants within the last 2 weeks, 4 weeks for fluoxetine.
• Recent (last 3 months) substance abuse or dependence. Urine drug screen will be obtained if a question arises.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Russell E Scheffer, MD

  Medical College of Wisconsin; Children's Hospital of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2003
• Study Completion: November 1, 2005
• Last Updated: March 7, 2008

Record last verified: 2008-03

Locations

US (1)