Treatment and Outcome of Early Onset Bipolar Disorder

Northwell Health

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: Ziprasidone

Drug: Lithium

Drug: Olanzapine

Drug: Divalproex

Drug: Aripriprazole

Drug: Quetiapine

Drug: Risperidone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00048802

DSIR 84-CTM

R01MH060845 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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