Clinical trial NCT00195780: A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
Official title: An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: Bipolar I Disorder
Depakote
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 227
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.


Eligibility criteria: Inclusion Criteria:

* Subject is between 10 and 17 years of age, inclusive, on Day 1 and weighs at least 60 lbs (27 kg).
* Subject has a current psychiatric diagnosis of bipolar I disorder, manic or mixed episode, based on the K-SAD-PL interview and DSM-IV-TR criteria.
* Subject is an outpatient in a manic or mixed episode with a YMRS score of greater than or equal to 16 during Screening and at Day 1.

Exclusion Criteria:

* Has an Axis I disorder other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder, Enuresis, Encopresis, Parasomnias, Agoraphobia, Specific Phobia, Social Phobia or Separation Anxiety Disorder; or subject has an Axis II disorder that would interfere with the subject's ability to comply with study procedures or confound interpretation of the study results. Subject meets DSM-IV-TR criteria for substance abuse within the month prior to Screening, or meets the criteria for substance dependence within the three months prior to Screening, or exhibits signs of drug or alcohol intoxication or withdrawal at Day 1.
* Is expected to require hospitalization for the current manic or mixed episode.
* Is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others.
* Has a history of a chronic or acute medical disorder that, in the opinion of the investigator, would preclude compliance with the protocol, or confound interpretation of the study results.
* Has a history of, or is suspected of having a seizure disorder.
* Has any central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease.
* Has Platelet count less than or equal to 100,000/µL
* Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening.
* Is taking a protocol allowed medication for ADHD that has not been stable for at least 3 months prior to Day 1, or that, in the investigator's opinion, may be exacerbating mood symptoms.
* Requires anticoagulant drug therapy.

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Y-MRS
measure: CGI-S
measure: C-GAS
measure: CDRS-R
measure: CGSQ
measure: responders
measure: remitters
Other outcomes:
Locations:
city: San Diego
country: United States
facility: PCSD Feighner Research
state: California
city: San Marcos
country: United States
facility: PCSD Feighner Research
state: California
city: Altamonte Springs
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Winter Park
country: United States
facility: Kolin Research Group
state: Florida
city: Decatur
country: United States
facility: Northlake Medical Research Center
state: Georgia
city: Eagle
country: United States
facility: Mountain West Clinical Trials
state: Idaho
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Newton
country: United States
facility: Cientifica Inc.
state: Kansas
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Shreveport
country: United States
facility: Brentwood Research Institute
state: Louisiana
city: Bangor
country: United States
facility: Acadia Hospital
state: Maine
city: Baltimore
country: United States
facility: Pharmasite Research
state: Maryland
city: Chapel Hill
country: United States
facility: North Carolina Neuropsychiatry, PA
state: North Carolina
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Canton
country: United States
facility: Neuro Behavioral Clinical Research, INC.
state: Ohio
city: Cincinnati
country: United States
facility: Psychiatric Professional Services
state: Ohio
city: Lyndhurst
country: United States
facility: Rakesh Ranjan, M.D. & Associates, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Bala Cynwyd
country: United States
facility: Clinical Trials Specialists
state: Pennsylvania
city: Memphis
country: United States
facility: UTHSC, Sept. of Psychiatry, College of Medicine
state: Tennessee
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References: