A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158687
• Other study ID #: CP692.2001
• Status: Completed
• Phase: Phase 2
• Start date: November 26, 2019
• Est. completion date: December 22, 2020

Study information

• Verified date: December 2023
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• CTP-692
Administered as powder for oral solution.
• Placebo
Administered as powder for oral solution.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Synexus Clinical Research US, Inc.	Atlanta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	Donald J. Garcia Jr., MD, PA	Austin	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Synexus Clinical Research US, Inc.	Cerritos	California
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	Uptown Research Institute, LLC	Chicago	Illinois
United States	ProScience Research Group	Culver City	California
United States	InSite Clinical Research, LLC	DeSoto	Texas
United States	CBH Health, LLC	Gaithersburg	Maryland
United States	Collaborative Neuroscience Network, LLC	Garden Grove	California
United States	Synexus Clinical Research US, Inc.	Jamaica	New York
United States	Altea Research Institute	Las Vegas	Nevada
United States	Innovative Clinical Research, Inc.	Lauderhill	Florida
United States	Synergy San Diego	Lemon Grove	California
United States	Pillar Clinical Research, LLC	Lincolnwood	Illinois
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	Hassman Research Institute	Marlton	New Jersey
United States	Behavioral Clinical Research, Inc.	North Miami	Florida
United States	Pacific Research Partners, LLC	Oakland	California
United States	Pillar Clinical Research, LLC	Richardson	Texas
United States	Woodland Research Northwest, LLC	Rogers	Arkansas
United States	Arch Clinical Trials, LLC	Saint Louis	Missouri
United States	Collaborative Neuroscience Network, LLC	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Concert Pharmaceuticals	Cognitive Research Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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