Translational Neuroscience Optimization of GlyT1 Inhibitor

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this study is to test the efficacy of treatment with one of two does of a glycine transporter inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function. Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I) and placebo twice daily in addition to their antipsychotic medication for 2 treatment periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout period lasting approximately 3 weeks.

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

Details

• Lead Sponsor: Yale University

Criteria

Inclusion Criteria:

• 1) Males or females 21 to 65 years of age (inclusive).

• 2) Diagnosis of Schizophrenia or Schizoaffective Disorder

• 3) Able to provide written informed consent.

• 4) Only CYP2D6 extensive metabolizers.

Exclusion Criteria:

• 1) No ongoing acute medical issues

• 2) Clinically significant ECG abnormality

• 3) Blood donation within eight weeks of the start of the study

• 4) Current treatment with Clozapine