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Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2002 by National Institute of Mental Health (NIMH).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221429
First Posted: September 22, 2005
Last Update Posted: February 23, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Cincinnati
Information provided by:
National Institute of Mental Health (NIMH)
  Purpose
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.

Condition Intervention Phase
Bipolar Disorder Drug: lithium sodium divalproex Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pediatric Bipolar Collaborative Mood Stabilizer Trial

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • YMRS & CGI-I

Secondary Outcome Measures:
  • CDRS & MRS

Estimated Enrollment: 154
Study Start Date: March 2001
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:

  1. 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.
  2. To collect data on possible predictors of acute treatment response to the two active treatments.
  3. 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.
  4. To develop safety and efficacy data about the use of stimulant medications in these subject while treated with a mood stabilizer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 7.0 – 17 years of age
  2. Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria
  3. Score of > 14 on the Y-MRS
  4. Normal intelligence
  5. Ability and willingness to provide assent and informed, written consent from at least one parent or legal guardian
  6. 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221429


Locations
United States, Ohio
University of Cincinnati Medical Center/Medical Sciences Building
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
University of Cincinnati
Investigators
Principal Investigator: Robert A Kowatch, MD University of Cincinnati
  More Information

ClinicalTrials.gov Identifier: NCT00221429     History of Changes
Other Study ID Numbers: R01MH063632 ( U.S. NIH Grant/Contract )
DSIR CT-M
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: February 23, 2006
Last Verified: November 2002

Keywords provided by National Institute of Mental Health (NIMH):
child
adolescent

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Valproic Acid
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
GABA Agents
Neurotransmitter Agents