Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Otsuka

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080327

CN138-113 ST

Details and patient eligibility

About

A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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370 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Aripiprazole

Drug: Aripiprazole

Drug: Aripiprazole

2

Active Comparator group

Treatment:

Drug: Aripiprazole

Drug: Aripiprazole

Drug: Aripiprazole

3

Active Comparator group

Treatment:

Drug: Aripiprazole

Drug: Aripiprazole

Drug: Aripiprazole

4

Placebo Comparator group

Treatment:

Drug: Placebo