Aripiprazole in Adolescents With Schizophrenia (APEX 239)

Otsuka

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole tablet, 10 mg; Drug: Aripiprazole tablet, 30 mg; Drug: Placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102063

31-03-239

Details and patient eligibility

About

The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

Enrollment: 302 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of Schizophrenia 1

Exclusion criteria

• Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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302 participants in 3 patient groups, including a placebo group

Aripiprazole 10 mg/day Group

Active Comparator group

Description:

Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25

Treatment:

Drug: Aripiprazole tablet, 10 mg

Aripiprazole 30 mg/day Group

Active Comparator group

Description:

Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25

Treatment:

Drug: Aripiprazole tablet, 30 mg

Placebo Group

Placebo Comparator group

Description:

Participants were given a single pill administered once daily

Treatment:

Drug: Placebo tablet