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

Bipolar Disorder Clinical Trial

Official title:

A Pilot Study Of Safety And Effectiveness For Depakote ER In Pediatric Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199966
• Other study ID #: CHW 03/163, HRRC 539-03
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: March 6, 2008
• Start date: December 2003
• Est. completion date: November 2005

Study information

• Verified date: March 2008
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

There is no accepted, well-studied treatment for Pediatric Bipolar Disorder and treatment has often followed from adult studies. The primary objectives for this study are to determine if subjects can safely and easily be switched from divalproex sodium to Depakote ER and to determine if Depakote ER is both safe and effective for pediatric patients with Bipolar I or II. Secondary objectives include determining the serum levels of valproic acid 20 hours after administration of Depakote ER at a steady rate and determining if co-administration of stimulants will effect the serum levels of valproic acid. Thirty subjects, ages 6-17 years, with a diagnosis of Bipolar I or II who are currently asymptomatic, according to a score of less than 10 on the Young Mania Rating Scale, or who desire to change to once daily dosing, or desire to change because of the likelihood of decreased side-effects, will be recruited from our clinic and the community. If subjects have completed baseline evaluations (including diagnostic confirmation), labs, and rating scales and are still eligible to participate, subjects will be switched in one night from twice-a-day divalproex sodium (DVP) to divalproex sodium extended release (DVP ER).

The potential benefits of the research are that new information will be added to the field of child and adolescent psychiatry and the possibility that the medication change may result in improved symptoms of mania or side effects of medications related to peak and trough levels. The potential benefits of this study outweigh the possible risks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Divalproex sodium extended release

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Young Mania Rating Scale (YMRS), rate at baseline, Week 2,4,6,&8
Secondary	Kiddie version of the Schedule for Affective Disorders and Schizophrenia (KSADS), assessed at baseline only.
Secondary	Child Depression Rating Scale (CDRS), rate at baseline through Week 8.
Secondary	Clinical Global Impression: Improvement and Severity (CGI), for mania, depression and ADHD. Rate from baseline through Week 8.
Secondary	Conner's Parent and Teacher Rating Scales (CRS). Rate from baseline through Week 8.
Secondary	Side Effect For Children & Adolescents (SEFCA). Rate from baseline through Week 8.