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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2004-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder

NCT00221429

Bipolar Disorder

COMPLETED PHASE3

Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders

NCT00221403

Bipolar Disorder

COMPLETED PHASE3

Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

NCT02456454

Bipolar Disorder

COMPLETED PHASE3

Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder

NCT00025935

Mood Disorder

RECRUITING

Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents

NCT00332098

Bipolar Disorder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clozapine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No