Treatment and Outcome of Early Onset Bipolar Disorder

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-08-31

Brief Summary

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

This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.

Related Clinical Trials

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

A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

NCT00094432

Bipolar I Disorder

COMPLETED PHASE3

Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder

NCT00194012

Bipolar Disorder

COMPLETED PHASE3

Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode

NCT01977300

Bipolar I Disorder

COMPLETED PHASE3

Aripiprazole in Late Life Bipolar Disorder

NCT00194038

Bipolar Disorder

COMPLETED PHASE4

Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness

NCT00071253

Bipolar Disorder

TERMINATED PHASE4

Detailed Description

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

In children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted.

Participants in this study are treated with lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. The first group will continue to receive active mood stabilizer and atypical antipsychotic medication. The second group will receive active mood stabilizer and placebo. Participants are assessed weekly and followed for up to 18 months.

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.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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

Lithium

Intervention Type DRUG

Olanzapine

Intervention Type DRUG

Divalproex

Intervention Type DRUG

Risperidone

Intervention Type DRUG

Quetiapine

Intervention Type DRUG

Ziprasidone

Intervention Type DRUG

Aripriprazole

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Have a diagnosis of Bipolar I Disorder;
* Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode;
* Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa);
* Live in the NY Metropolitan area;
* Able to attend weekly to biweekly office visits

Exclusion Criteria

* Medical contraindication to treatment with lithium and divalproex
* Seizure disorder
* Pregnancy
* Unwillingness to use acceptable methods of birth control if sexually active
* IQ less than 70
* Substance-induced mood disorder or mood disorder due to a general medical condition
* Prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study
* Potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode
* High risk for running away or truancy

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No