Translational Neuroscience Optimization of GlyT1 Inhibitor (NCATS)

Yale University

Status and phase: Completed; Phase 2

Conditions: Cognitive Impairments Associated With Schizophrenia

Treatments: Drug: PF-03463275; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01911676

4UH3TR000960-02 (U.S. NIH Grant/Contract)

1303011716

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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71 participants in 3 patient groups, including a placebo group

PF-03463275 Active Dose #1

Experimental group

Description:

Active dose between 40mg

Treatment:

Drug: PF-03463275

PF-03463275 Active Dose #2

Experimental group

Description:

Active dose between 60mg

Treatment:

Drug: PF-03463275

Placebo

Placebo Comparator group

Description:

Placebo- no active dose of PF-03463275.

Treatment:

Drug: Placebo