Effect on Cognitive Function of a Treatment With Aripiprazole
November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients
To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of Schizophrenia
- score of 2-6 in the CGI-S scale at basline
- ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment
Exclusion Criteria:
- women of child bearing potential
- women pregnant or breast feeding
- patients with a score of 0,-1 or 7
- substance use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Switch
|
Tablets, oral, 15 mg, once daily, 12 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Clinical Global Impression scale at endpoint
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Change in Clinical Global Impression scale and cognition scales at endpoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (ACTUAL)
March 1, 2006
Study Completion (ACTUAL)
March 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
May 24, 2006
First Posted (ESTIMATE)
May 25, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
November 8, 2013
Last Update Submitted That Met QC Criteria
November 7, 2013
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- CN138-166
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.