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Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lithium sodium divalproex
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring child, adolescent

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • University of Cincinnati Medical Center/Medical Sciences Building

Outcomes

Primary Outcome Measures

YMRS & CGI-I

Secondary Outcome Measures

CDRS & MRS

Full Information

First Posted
September 14, 2005
Last Updated
February 22, 2006
Sponsor
National Institute of Mental Health (NIMH)
Collaborators
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT00221429
Brief Title
Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
Official Title
Pediatric Bipolar Collaborative Mood Stabilizer Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2002
Overall Recruitment Status
Unknown status
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Mental Health (NIMH)
Collaborators
University of Cincinnati

4. Oversight

5. Study Description

Brief Summary
This study will compare 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 LI, DVP, and PBO in the acute phase treatment of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents. Our hypothesis is that differential efficacy will be observed with the following predicted order of response: DVP = LI > PBO. Secondary Aims: To collect systematic safety data on the incidence of weight gain and the development of insulin resistance and hyperandrogenism in bipolar adolescent females treated with LI, DVP, or LI + DVP. To collect data on possible predictors of acute treatment response to the two active treatments. To provide descriptive information on the stability of acute phase response to monotherapy with either LI or DVP over 6 months of continuation phase treatment. To develop safety and efficacy data about the use of stimulant medications in these subject while treated with a mood stabilizer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
child, adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
154 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lithium sodium divalproex
Primary Outcome Measure Information:
Title
YMRS & CGI-I
Secondary Outcome Measure Information:
Title
CDRS & MRS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Kowatch, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center/Medical Sciences Building
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

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Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder

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