A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adult Patients With Schizophrenia
1 other identifier
interventional
326
1 country
26
Brief Summary
The objective of this study is to assess the safety and efficacy of 3 different doses of CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on stable dopaminergic antipsychotic medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Nov 2019
Shorter than P25 for phase_2 schizophrenia
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedStudy Start
First participant enrolled
November 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2020
CompletedResults Posted
Study results publicly available
December 22, 2023
CompletedDecember 22, 2023
December 1, 2023
1.1 years
November 7, 2019
December 7, 2023
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
PANSS measures symptom severity in participants with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item is rated with 1 to 7 points. The PANSS is scored by summation of ratings across items such that the score ranges are 7 to 49 for each of the Positive and Negative Scales and 16 to 112 for the General Psychopathology Scale. The PANSS total score is a sum of scores from all the 30 items and the scores range from 30 to 210, where a higher score represents more severe symptoms, and lower scores represent a better quality of life in participants with schizophrenia. A negative change from baseline indicates low severity of symptoms.
Baseline, Week 12
Secondary Outcomes (2)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12
Baseline, Week 12
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12
Baseline, Week 12
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks.
CTP-692 1 gram QD
EXPERIMENTALParticipants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks.
CTP-692 2 grams QD
EXPERIMENTALParticipants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks.
CTP-692 4 grams QD
EXPERIMENTALParticipants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
- 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
You may not qualify if:
- Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Concert Pharmaceuticalslead
- Cognitive Research Corporationcollaborator
Study Sites (26)
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758, United States
Synexus Clinical Research US, Inc.
Cerritos, California, 90703, United States
ProScience Research Group
Culver City, California, 90230, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
Pacific Research Partners, LLC
Oakland, California, 94607, United States
Collaborative Neuroscience Network, LLC
Torrance, California, 90502, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Uptown Research Institute, LLC
Chicago, Illinois, 60640, United States
Pillar Clinical Research, LLC
Lincolnwood, Illinois, 60712, United States
CBH Health, LLC
Gaithersburg, Maryland, 20877, United States
Arch Clinical Trials, LLC
St Louis, Missouri, 63118, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Hassman Research Institute
Marlton, New Jersey, 08053, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Synexus Clinical Research US, Inc.
Jamaica, New York, 11432, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407, United States
Donald J. Garcia Jr., MD, PA
Austin, Texas, 78737, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
InSite Clinical Research, LLC
DeSoto, Texas, 75115, United States
Pillar Clinical Research, LLC
Richardson, Texas, 75080, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Colleen E. Hamilton
- Organization
- Concert Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 12, 2019
Study Start
November 26, 2019
Primary Completion
December 22, 2020
Study Completion
December 22, 2020
Last Updated
December 22, 2023
Results First Posted
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share