A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia
NCT ID: NCT04158687
Last Updated: 2023-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
326 participants
INTERVENTIONAL
2019-11-26
2020-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks.
Placebo
Administered as powder for oral solution.
CTP-692 1 gram QD
Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks.
CTP-692
Administered as powder for oral solution.
CTP-692 2 grams QD
Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks.
CTP-692
Administered as powder for oral solution.
CTP-692 4 grams QD
Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks.
CTP-692
Administered as powder for oral solution.
Interventions
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CTP-692
Administered as powder for oral solution.
Placebo
Administered as powder for oral solution.
Eligibility Criteria
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Inclusion Criteria
* Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (PANSS) total score of 70-110
* Patients currently treated with one antipsychotic medication
Exclusion Criteria
* Patients currently taking clozapine
* History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
* Patients with positive blood screen for human immunodeficiency virus (HIV) antibody and/or hepatitis B virus surface antigen
* Patients with history of renal disease or those taking medications to treat renal disease
18 Years
55 Years
ALL
No
Sponsors
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Cognitive Research Corporation
INDUSTRY
Concert Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, United States
Synexus Clinical Research US, Inc.
Cerritos, California, United States
ProScience Research Group
Culver City, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Synergy San Diego
Lemon Grove, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
Collaborative Neuroscience Network, LLC
Torrance, California, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Uptown Research Institute, LLC
Chicago, Illinois, United States
Pillar Clinical Research, LLC
Lincolnwood, Illinois, United States
CBH Health, LLC
Gaithersburg, Maryland, United States
Arch Clinical Trials, LLC
St Louis, Missouri, United States
Altea Research Institute
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Hassman Research Institute
Marlton, New Jersey, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Synexus Clinical Research US, Inc.
Jamaica, New York, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States
Donald J. Garcia Jr., MD, PA
Austin, Texas, United States
Community Clinical Research, Inc.
Austin, Texas, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP692.2001
Identifier Type: -
Identifier Source: org_study_id