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Clozapine vs. Placebo in Treatment-Refractory Bipolar Disorder in Children and Adolescents | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Clozapine vs. Placebo in Treatment-Refractory Bipolar Disorder in Children and Adolescents

Clozapine vs Placebo In Treatment-Refractory Bipolar Disorder In Children And Adolescents

NCT00036582•National Institute of Mental Health (NIMH)

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and effectiveness of clozapine in children and adolescents with treatment resistant bipolar disorder. This study will also explore how the brain functions in early-onset bipolar disorder.

Detailed Description

Bipolar disorder (BPD) in children and adolescents is a serious illness that carries a high risk for chronicity, impairing comorbidities, and completed suicide. Treatment options are often limited by inefficacy or intolerable side effects. Open trials in adult bipolar subjects and several case series in children and adolescents provide preliminary evidence that clozapine, an atypical antipsychotic, may be effective in treatment-resistant bipolar disorder. The first specific aim of this study is to test the efficacy and safety of clozapine compared to placebo in a double-blind study of children and adolescents with treatment refractory BPD. Other specific aims involve exploring the pathophysiology of early-onset BPD by 1) testing the hypotheses that, compared to controls, children with BPD have increased psychophysiological reactivity to emotional stimuli and decreased prepulse inhibition; 2) obtaining samples of genetic material from affected probands and their parents for later analysis; and 3) identifying anatomic changes in the brains of children with BPD using structural MRI.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ages 8-17
•Currently meets criteria for bipolar disorder, manic or mixed, as determined by the K-SADS diagnostic interview.
•Treatment-resistant, defined as a history of unsuccessful trials of lithium (documented level of greater than 0.8 mEq/L), valproic acid (documented level of greater than 50 ug/ml), carbamazepine (documented level greater than or equal to 6 ug/ml), a neuroleptic as well as a combination of two of these agents. Each trial must have been at least 6 weeks long. A trial will be considered unsuccessful if the medication was discontinued because of intolerable side-effects.
•The child should be in treatment with a community psychiatrist to whom they will return upon completion of the study.
•Current CGAS score less than 50
•Control subjects will be age- and sex- matched to the BPD subjects. They will have normal physical and neurological examinations, and an identified primary care physician. Both control subjects and their first-degree relatives must be free of current or past psychopathology.

Exclusion Criteria

•Full scale IQ less than 80
•Meets criteria for substance use disorder in the three months prior to randomization
•Currently pregnant, lactating, or sexually active without using a barrier method of contraception
•Previous treatment with clozapine
•History of seizures
•History of leukopenia or agranulocytosis
•Presence of an unstable medical illness
•I.Q less than 80; ongoing medical illness; neurologic disorder (including seizures); pregnancy; meeting past or present criteria for any diagnosis on the K-SADS-PL; meeting criterion A of post-traumatic stress disorder (exposure to a traumatic event).

Locations (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, United States

Key Dates

Start Date

May 1, 2002

Completion Date

February 1, 2004

Last Updated

March 4, 2008

Enrollment

116

Estimated participants

Conditions

Bipolar Disorder

Interventions

Clozapine

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clozapine vs. Placebo in Treatment-Refractory Bipolar Disorder in Children and Adolescents

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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