Conditions: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 732
Healthy volunteers: no

Brief summary:
This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Detailed description:

Arms:
arm 1: Participants received placebo orally once a day for 6 weeks. arm 2: Participants received cariprazine 1.5 mg orally once a day for 6 weeks. arm 3: Participants received cariprazine 3.0 mg orally once a day for 6 weeks. arm 4: Participants received cariprazine 4.5 mg orally once a day for 6 weeks. arm 5: Participants received risperidone 4.0 mg orally once a day for 6 weeks.

Interventions: intervention 1: Placebo intervention 2: Cariprazine intervention 3: Risperidone
Intervention descriptions: intervention 1: Placebo was supplied in capsules. intervention 2: Cariprazine was supplied in capsules intervention 3: Risperidone was supplied in capsules

Protocol document: