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Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Aripiprazole
Aripiprazole
Placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bristol-Meyers Squibb Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Change at endpoint in schizophrenia rating scale

Secondary Outcome Measures

Clinical Global Improvement scale at endpoint and time to response

Full Information

First Posted
March 26, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00080327
Brief Title
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
Official Title
A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
370 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 2mg, Once daily, 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 5mg, Once daily, 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 10mg, Once daily, 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0mg, Once daily, 6 weeks.
Primary Outcome Measure Information:
Title
Change at endpoint in schizophrenia rating scale
Secondary Outcome Measure Information:
Title
Clinical Global Improvement scale at endpoint and time to response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months
Facility Information:
Facility Name
Bristol-Meyers Squibb Call Center
City
Wallingford
State/Province
Connecticut
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

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