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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: CTP-692

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group, LLC
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest, LLC
  • California
    • Cerritos, California, United States, 90703
      • Synexus Clinical Research US, Inc.
    • Culver City, California, United States, 90230
      • ProScience Research Group
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network, LLC
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Oakland, California, United States, 94607
      • Pacific Research Partners, LLC
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Network, LLC
  • Florida
    • Lauderhill, Florida, United States, 33319
      • Innovative Clinical Research, Inc.
    • North Miami, Florida, United States, 33161
      • Behavioral Clinical Research, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Atlanta, Georgia, United States, 30328
      • Synexus Clinical Research US, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Uptown Research Institute, LLC
    • Lincolnwood, Illinois, United States, 60712
      • Pillar Clinical Research, LLC
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health, LLC
  • Missouri
    • Saint Louis, Missouri, United States, 63118
      • Arch Clinical Trials, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute
  • New York
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc.
    • Jamaica, New York, United States, 11432
      • Synexus Clinical Research US, Inc.
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Carolina Clinical Trials, Inc.
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • Austin, Texas, United States, 78737
      • Donald J. Garcia Jr., MD, PA
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research, LLC
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks.	Drug: Placebo; Administered as powder for oral solution.
Experimental: CTP-692 1 gram QD; Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks.	Drug: CTP-692; Administered as powder for oral solution.
Experimental: CTP-692 2 grams QD; Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks.	Drug: CTP-692; Administered as powder for oral solution.
Experimental: CTP-692 4 grams QD; Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks.	Drug: CTP-692; Administered as powder for oral solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at 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.	Baseline, Week 12
Change From Baseline in Personal and Social Performance (PSP) Scale at 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.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Concert Pharmaceuticals
• Collaborators: Cognitive Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): December 22, 2020
• Study Completion (Actual): December 22, 2020

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CP692.2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No