The Young Adult and Pediatric Bipolar Study

Phase 4

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: Extended-Release Carbamazepine

• Registration Number: NCT00350857
• Lead Sponsor: Validus Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-10
• Study First Submitted QC: 2006-07-10
• Study First Posted: 2006-07-11
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2009-11
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Equetro active	Extended-Release Carbamazepine	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (26)

11 Shire Clinical Research Site; 🇺🇸 Altamonte Springs, Florida, United States

17 Segal Institute for Clinical Research; 🇺🇸 Fort Lauderdale, Florida, United States

19 Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States

23 Shire Clinical Research Site; 🇺🇸 Jacksonville, Florida, United States

21 Scientific Clinical Research; 🇺🇸 North Miami, Florida, United States

14 Northlake Medical Research; 🇺🇸 Decatur, Georgia, United States

04 Mountain West Clinical Trials; 🇺🇸 Eagle, Idaho, United States

25 Capstone Clinical Research; 🇺🇸 Libertyville, Illinois, United States

15 Psychiatric Associates; 🇺🇸 Overland Park, Kansas, United States

27 Owensboro Behavioral Care; 🇺🇸 Owensboro, Kentucky, United States

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