Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Collaborator:	University of Cincinnati
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00221429

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Pediatric Bipolar Collaborative Mood Stabilizer Trial

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lithium carbonate Lithium citrate

U.S. FDA Resources

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:

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.

Eligibility

Ages Eligible for Study:	7 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	R01 MH63632, DSIR CT-M
Study First Received:	September 14, 2005
Last Updated:	February 22, 2006
ClinicalTrials.gov Identifier:	NCT00221429 History of Changes
Health Authority:	United States: Federal Government

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

child
adolescent

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antipsychotic Agents
Antimanic Agents

Valproic Acid
Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
GABA Agents
Central Nervous System Agents
Anticonvulsants
Lithium

ClinicalTrials.gov processed this record on November 09, 2009