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Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00080327
Recruitment Status : Completed
First Posted : March 30, 2004
Last Update Posted : November 11, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
Study Start Date : November 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Drug: Aripiprazole
Tablets, Oral, 2mg, Once daily, 6 weeks.
Other Name: Abilify
Active Comparator: 2 Drug: Aripiprazole
Tablets, Oral, 5mg, Once daily, 6 weeks.
Other Name: Abilify
Active Comparator: 3 Drug: Aripiprazole
Tablets, Oral, 10mg, Once daily, 6 weeks.
Other Name: Abilify
Placebo Comparator: 4 Drug: Placebo
Tablets, Oral, 0mg, Once daily, 6 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change at endpoint in schizophrenia rating scale

Secondary Outcome Measures :
  1. Clinical Global Improvement scale at endpoint and time to response

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080327


Locations
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United States, Connecticut
Bristol-Meyers Squibb Call Center
Wallingford, Connecticut, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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ClinicalTrials.gov Identifier: NCT00080327    
Other Study ID Numbers: CN138-113 ST
First Posted: March 30, 2004    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: August 2008
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists