The Young Adult and Pediatric Bipolar Study

Bipolar I Disorder Clinical Trial

Official title:

A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350857
• Other study ID #: SPD417-311
• Status: Completed
• Phase: Phase 4
• First received: July 10, 2006
• Last updated: February 19, 2014
• Start date: July 2006
• Est. completion date: October 2007

Study information

• Verified date: November 2009
• Source: Validus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Key Inclusion Criteria:

1. DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.

2. A lifetime history of bipolar disorder symptoms for at least 2 months.

3. YMRS score greater than or equal to 16.

4. CGI-S score greater than or equal to 4.

5. Male or female outpatient aged between 10-17 years old inclusive at the time of consent.

6. Functioning at an age-appropriate level intellectually, as deemed by the Investigator.

7. The subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study.

8. Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.

Exclusion Criteria:

• Key Exclusion Criteria:

1. Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.

2. A history of lack of therapeutic response or hypersensitivity to the study drug.

3. A greater than or equal to 50% reduction in YMRS between Screening and Baseline.

4. Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.

5. A history of aplastic anemia, agranulocytosis or bone marrow depression.

6. A history of seizure disorder, other than a single childhood febrile seizure.

7. A history of severe, unstable asthma.

8. Current hospitalization for psychiatric symptoms.

9. History of alcohol or other substance abuse or dependence.

10. Pregnant or lactating females.

11. Body weight less than or equal to 25 kg.

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:
• Extended-Release Carbamazepine

Locations

Country	Name	City	State
United States	11 Shire Clinical Research Site	Altamonte Springs	Florida
United States	13 Pharmasite Research, Inc	Baltimore	Maryland
United States	12 Claghorn-Lesem Research Clinic	Bellaire	Texas
United States	01 Nccacrf	Chapel Hill	North Carolina
United States	06 University of Cincinnati, College of Medicine	Cincinnati	Ohio
United States	09 Discovery and Wellness Center for Children	Cleveland	Ohio
United States	07 Center for Pediatric Psychiatry	Dallas	Texas
United States	14 Northlake Medical Research	Decatur	Georgia
United States	04 Mountain West Clinical Trials	Eagle	Idaho
United States	17 Segal Institute for Clinical Research	Fort Lauderdale	Florida
United States	19 Sarkis Clinical Trials	Gainesville	Florida
United States	24 Red Oak Psychiatry Associates	Houston	Texas
United States	23 Shire Clinical Research Site	Jacksonville	Florida
United States	10 RID Clinical Research, Inc	Lake Jackson	Texas
United States	25 Capstone Clinical Research	Libertyville	Illinois
United States	26 Suburban Research Associates	Media	Pennsylvania
United States	08 Dominion Clinical Research	Midlothian	Virginia
United States	16 Rogers Center for Research and Training	Milwaukee	Wisconsin
United States	20 Shire Clinical Research Site	Milwaukee	Wisconsin
United States	21 Scientific Clinical Research	North Miami	Florida
United States	03 IPS Research	Oklahoma City	Oklahoma
United States	15 Psychiatric Associates	Overland Park	Kansas
United States	27 Owensboro Behavioral Care	Owensboro	Kentucky
United States	02 Finger Lakes Clinical Research	Rochester	New York
United States	05 Brentwood Research Institute	Shreveport	Louisiana
United States	22 Brighton Research Group	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Validus Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment.		6 months	Yes
Secondary	Reduction of bipolar symptoms as assessed by the Young Mania Rating Scale (YMRS), Clinical Global Impressions Scale (CGI) and Children's Depression Rating Scale (CDRS-S) after 6 months of treatment.		6 months	No