Translational Neuroscience Optimization of GlyT1 Inhibitor

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cognitive Impairments Associated With Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-03463275 Active Dose #1

Active dose between 40mg

Group Type EXPERIMENTAL

PF-03463275

Intervention Type DRUG

PF-03463275 Active Dose #2

Active dose between 60mg

Group Type EXPERIMENTAL

PF-03463275

Intervention Type DRUG

Placebo

Placebo- no active dose of PF-03463275.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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PF-03463275

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No