A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia
- Registration Number
- NCT04158687
- Lead Sponsor
- Concert Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks. CTP-692 1 gram QD CTP-692 Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks. CTP-692 2 grams QD CTP-692 Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks. CTP-692 4 grams QD CTP-692 Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12 Baseline, Week 12 The CGI-S rating scale is a commonly used measure of symptom severity and treatment response. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment and the score ranges from 1 to 7: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. A higher score represents more severe symptoms. A negative change from baseline indicates low severity of symptoms.
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12 Baseline, Week 12 PSP scale is a measure of the personal and social functioning of participants with psychiatric disorders within four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Each domain was assessed on a 6-point scale: 1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe. The final global score is defined according to a summary instruction table converting four domain scores into a single, overall rating from 1 to 100: 71 to 100 represent mild degree of difficulty; 31 to 70 represent varying degrees of disability, and 1 to 30 represent functioning so poorly as to require intensive supervision. Higher scores represent better personal and social function. A positive change from baseline indicates better personal and social function.
Trial Locations
- Locations (21)
Synexus Clinical Research US, Inc.
🇺🇸Jamaica, New York, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Uptown Research Institute, LLC
🇺🇸Chicago, Illinois, United States
Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
🇺🇸Rogers, Arkansas, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸Torrance, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Behavioral Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Pillar Clinical Research, LLC
🇺🇸Richardson, Texas, United States
CBH Health, LLC
🇺🇸Gaithersburg, Maryland, United States
Arch Clinical Trials, LLC
🇺🇸Saint Louis, Missouri, United States
Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
Carolina Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, 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