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OpenTrials
Completed

NCT Number: NCT00080327

Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bristol-Meyers Squibb Call Center

Wallingford, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Aripiprazole

Drug

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

Other names: Abilify

Placebo

Drug

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

Primary outcomes

  1. Change at endpoint in schizophrenia rating scale

Secondary outcomes

  1. Clinical Global Improvement scale at endpoint and time to response

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka America Pharmaceutical

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 30, 2004
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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