Translational Neuroscience Optimization of GlyT1 Inhibitor
Completed · Phase 2 · Has a placebo group
Conditions studied: Cognitive Impairments Associated With Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT01911676
- Run by
- Yale University
- People needed
- 71
- Starts
- 2013-08-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2024-08-19
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Connecticut Mental Health Center — New Haven, Connecticut, United States
- VA Connecticut Healthcare System — West Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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