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

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bipolar Disorder

Interventions

RisperidoneDRUG

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The change in the total YMRS score from baseline at the 3-week endpoint

Secondary Outcomes

Effects on secondary efficacy variables (YMRS response and onset of maintained response, Clinical Global Impression Scale - Bipolar Disorder [CGI-BP]), safety, tolerability, and pharmacokinetics.

Data from ClinicalTrials.gov

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