Status:
COMPLETED
Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
7-18 years
Phase:
PHASE3
Brief Summary
This study compared the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.
Detailed Description
Primary Aim: To compare the efficacy of lithium (LI), divalproex (DVP), and placebo (PBO) in the acute phase treatment of symptomatic bipolar I disorder, mixed or manic episode, in children and adole...
Eligibility Criteria
Inclusion
- 7.0 - 17 years of age
- Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria
- Score of \> 14 on the Y-MRS
- Normal intelligence
- Ability and willingness to provide assent and informed, written consent from at least one parent or legal guardian
- No current general medical illnesses requiring medication
Exclusion
- 1\. A current or lifetime DSM-IV diagnosis of schizophrenia, autistic disorder, schizoaffective disorder, pervasive developmental disorder, or obsessive compulsive disorder 2. IQ \< 70 3. Patients with serious suicide risk 4. Concurrent cognitive-behavior therapy that is specifically focused on the child or adolescent's bipolar symptoms within 6 weeks of enrolling in this trial.
- 5\. Any use of psychotropic agents within the preceding 2 weeks, including neuroleptics, monoamine oxidase inhibitors, stimulants, antidepressants, or depot neuroleptics or fluoxetine in the past month 6. Current or history in past 3 months of a DSM-IV diagnosis of Substance Abuse/Dependence or use of illicit drugs or alcohol in the past 3 weeks. Patients who have a positive drug screen at intake, who would otherwise be eligible for the study, will be given the opportunity to repeat the drug screen 3 weeks later. They will be excluded if the second drug screen is positive.
- 7\. Pregnancy or sexually active females not using a reliable form of contraception 8. Previous adequate trial of either LI or DVP defined as; 3 weeks of DVP at serum levels between 75-125 OR dosage of at least 20 mg/kg; Lithium for at least 4 weeks at serum levels of .8 - 1.2 or dosage of at least 30 mg/kg.
- 9\. Allergies to LI, DVP or chlorpromazine. 10. Bipolar subjects who are currently stable on mood stabilizers or atypical neuroleptics.
- 11\. Bipolar subjects with Bipolar I disorder and ADHD who are stable on stimulants with or without concurrent mood stabilizers.
- 12\. Inpatient hospitalization within 6 months prior to screening. Partial hospitalization is acceptable.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00221429
Start Date
March 1 2001
End Date
February 1 2015
Last Update
February 8 2024
Active Locations (1)
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1
University of Cincinnati Medical Center/Medical Sciences Building
Cincinnati, Ohio, United States, 45267