Clinical trial NCT04158687: A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Cognitive Research Corporation
First posted: 2019-11-12
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group, LLC
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC
state: Arkansas
city: Cerritos
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute, LLC
state: Illinois
city: Lincolnwood
country: United States
facility: Pillar Clinical Research, LLC
state: Illinois
city: Gaithersburg
country: United States
facility: CBH Health, LLC
state: Maryland
city: Saint Louis
country: United States
facility: Arch Clinical Trials, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Jamaica
country: United States
facility: Synexus Clinical Research US, Inc.
state: New York
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Austin
country: United States
facility: Donald J. Garcia Jr., MD, PA
state: Texas
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research, LLC
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
Study officials:
References: