The Young Adult and Pediatric Bipolar Study

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.

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.

Study Overview

• Status: Completed
• Conditions: Bipolar I Disorder
• Intervention / Treatment: Drug: Extended-Release Carbamazepine

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • 11 Shire Clinical Research Site
    • Fort Lauderdale, Florida, United States, 33319
      • 17 Segal Institute for Clinical Research
    • Gainesville, Florida, United States, 32607
      • 19 Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32256
      • 23 Shire Clinical Research Site
    • North Miami, Florida, United States, 33161
      • 21 Scientific Clinical Research
  • Georgia
    • Decatur, Georgia, United States, 30333
      • 14 Northlake Medical Research
  • Idaho
    • Eagle, Idaho, United States, 83616
      • 04 Mountain West Clinical Trials
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • 25 Capstone Clinical Research
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • 15 Psychiatric Associates
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • 27 Owensboro Behavioral Care
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • 05 Brentwood Research Institute
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • 13 Pharmasite Research, Inc
  • New York
    • Rochester, New York, United States, 14618
      • 02 Finger Lakes Clinical Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • 01 Nccacrf
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • 06 University of Cincinnati, College of Medicine
    • Cleveland, Ohio, United States, 44106
      • 09 Discovery and Wellness Center for Children
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • 03 IPS Research
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • 26 Suburban Research Associates
  • Texas
    • Bellaire, Texas, United States, 77401
      • 12 Claghorn-Lesem Research Clinic
    • Dallas, Texas, United States, 75235
      • 07 Center for Pediatric Psychiatry
    • Houston, Texas, United States, 77090
      • 24 Red Oak Psychiatry Associates
    • Lake Jackson, Texas, United States, 77566
      • 10 RID Clinical Research, Inc
  • Virginia
    • Midlothian, Virginia, United States, 23112
      • 08 Dominion Clinical Research
    • Virginia Beach, Virginia, United States, 23452
      • 22 Brighton Research Group
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • 20 Shire Clinical Research Site
    • Milwaukee, Wisconsin, United States, 53227
      • 16 Rogers Center for Research and Training

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Equetro active	Drug: Extended-Release Carbamazepine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Validus Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: July 10, 2006
• First Submitted That Met QC Criteria: July 10, 2006
• First Posted (Estimate): July 11, 2006

Study Record Updates

• Last Update Posted (Estimate): February 20, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Carbamazepine
• Other Study ID Numbers: SPD417-311