Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00080327

Enrollment

370

Registered

2004-03-30

Start date

2003-11-30

Completion date

2004-09-30

Last updated

2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

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

Interventions

DRUGAripiprazole

Tablets, Oral, 2mg, Once daily, 6 weeks.

DRUGPlacebo

Tablets, Oral, 0mg, Once daily, 6 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change at endpoint in schizophrenia rating scale	—

Secondary

Measure	Time frame
Clinical Global Improvement scale at endpoint and time to response	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026