CompletedPhase 2

Translational Neuroscience Optimization of GlyT1 Inhibitor

United States71 participantsStarted 2013-08

Plain-language 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.

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

Timeframe: Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm.

Trial details

NCT IDNCT01911676

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

Results submitted2021-07-08

View on ClinicalTrials.gov More Cognitive Impairments Associated With Schizophrenia trials