Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00076115

CR003631

Details and patient eligibility

About

A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.

Full description

Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering from a current mixed or manic episode. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. Study medication will be increased to the target dosage during the first 7 days, then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10. The maximum tolerated dose will be given for the last 12 days of the study. Risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3, or 4 mg tablets (or matching placebo) each day for 3 weeks.

Enrollment

13 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Current primary diagnosis of bipolar I disorder, mania or mixed type
Aged between 10 and 17 years
Young Mania Rating Scale score greater than or equal to 20 at screening and baseline

Exclusion criteria

Known or suspected history of substance dependence
Significant risk for suicidal or violent behavior
Received electroconvulsive treatment within 4 weeks of baseline
Received a depot antipsychotic within 2 treatment cycle before baseline
Is unable to swallow medication taken in the form of tablets
Has a positive result for a urine drug screen done at baseline
Known or suspected seizure disorder
Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening
Known or suspected history of hypersensitivity or intolerance to risperidone
History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent