Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01488929|
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Negative Symptoms Cognitive Dysfunction||Drug: TC-5619 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||603 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Assess Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: 5 mg TC-5619
One tablet of 5 mg TC-5619 will be administered orally once a day.
Experimental: 50 mg TC-5619
One tablet of 50 mg TC-5619 will be administered orally once a day.
Placebo Comparator: Placebo
One tablet of placebo will be administered orally once a day.
- Change from baseline in the Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: 24 weeks ]
- Change from baseline in the Cogstate Schizophrenia Battery (CSB) [ Time Frame: 24 weeks ]
- Change from baseline in UCSD Performance Based Skills Assessment, brief version (UPSA-Brief) [ Time Frame: 24 weeks ]
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): NCT01488929
Show 64 Study Locations
|Principal Investigator:||David P Walling, PhD||Collaborative Neuroscience Network, Inc|