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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT04158687

Run by

Concert Pharmaceuticals

People needed

326

Starts

2019-11-26

Expected to finish

2020-12-22

Last updated by the study team

2023-12-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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