Phase 2
Completed N=71
Translational Neuroscience Optimization of GlyT1 Inhibitor
Cognitive Impairments Associated With Schizophrenia
Source: ClinicalTrials.gov NCT01911676 ↗
Enrolled (actual)
71
Serious AEs
1.1%
Results posted
Feb 2023
Primary outcomePrimary: Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) — 28.15; 25.22; 31.71; 28.3 score on scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) |
28.15; 25.22; 31.71; 28.3; 29.25; 26.33 | — |
| SECONDARY Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275 |
-0.169; 0.084; -0.629; -0.111; -0.544; -0.013 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01911676). 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.