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

• Status: Completed
• Trial end date: 2020-12-22
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the safety and efficacy of 3 different doses of CTP-692 administered once daily for 12 weeks to adult patients with schizophrenia on stable dopaminergic antipsychotic medication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Concert Pharmaceuticals
• Collaborator: Cognitive Research Corporation

Criteria

Inclusion Criteria:

• Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years

• Patients with clinically stable schizophrenia with residual symptoms defined as 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-5 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