A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
This study is currently recruiting participants.
Verified September 2012 by Abbott
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01655680
First received: May 25, 2012
Last updated: September 19, 2012
Last verified: September 2012
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First Received Date ICMJE | May 25, 2012 | ||||||||
Last Updated Date | September 19, 2012 | ||||||||
Start Date ICMJE | May 2012 | ||||||||
Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Cognition: MCCB (MATRICS Consensus Cognitive Battery) [ Time Frame: Change from baseline to week 24 ] [ Designated as safety issue: No ] Rater based interview |
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Original Primary Outcome Measures ICMJE |
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 24 [ Time Frame: Change from baseline to week 24 ] [ Designated as safety issue: No ] Rater based interview |
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Change History | Complete list of historical versions of study NCT01655680 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia | ||||||||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) | ||||||||
Brief Summary | This is a efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia. |
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Detailed Description | Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Schizophrenia | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 430 | ||||||||
Estimated Completion Date | February 2014 | ||||||||
Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Gender | Both | ||||||||
Ages | 20 Years to 55 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01655680 | ||||||||
Other Study ID Numbers ICMJE | M10-855, 2012-000418-13 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Abbott | ||||||||
Study Sponsor ICMJE | Abbott | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Abbott | ||||||||
Verification Date | September 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |