Translational Neuroscience Optimization of GlyT1 Inhibitor

Status:	Recruiting
Conditions:	Cognitive Studies, Schizophrenia
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	21 - 65
Updated:	10/10/2018
Start Date:	August 2013
End Date:	January 2019
Contact:	Emma Deaso, BA
Email:	emma.deaso@yale.edu
Phone:	203-974-7489

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.

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

We found this trial at

sites

Connecticut Mental Health Center

New Haven, Connecticut 06508

Principal Investigator: Deepak C D'Souza, MD

Phone: 203-974-7489

from

New Haven, CT