Phase 2 Completed N=326 Randomized Quadruple-blind Treatment

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

Schizophrenia

Source: ClinicalTrials.gov NCT04158687 ↗

Enrolled (actual)

326

Serious AEs

0.6%

Results posted

Dec 2023

Primary outcomePrimary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 — 82.1; 81.2; 81.6; 82.9 score on a scale — p=0.6003

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12	82.1; 81.2; 81.6; 82.9; -14.1; -15.9	0.6003
SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12	4.2; 4.1; 4.1; 4.2; -0.8; -0.8	0.8065
SECONDARY Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12	57.5; 58.7; 58.4; 58.0; 4.3; 4.6	0.6101

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

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Data sourced from ClinicalTrials.gov (NCT04158687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.