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Translational Neuroscience Optimization of GlyT1 Inhibitor (NCATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01911676
Recruitment Status : Active, not recruiting
First Posted : July 30, 2013
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairments Associated With Schizophrenia Drug: PF-03463275 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Translational Neuroscience Optimization of GlyT1 Inhibitor
Study Start Date : August 2013
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-03463275 Active Dose #1
Active dose between 40mg
 Drug: PF-03463275
Experimental: PF-03463275 Active Dose #2
Active dose between 60mg
 Drug: PF-03463275
Placebo Comparator: Placebo
Placebo- no active dose of PF-03463275.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Effect of PF-03463275 on Specific Cognitive Domains [ Time Frame: Change from baseline in cognitive measures at approximately 5 weeks ]
    To test the efficacy of PF-03463275 on cognitive test performance specifically, with change in specific cognitive domains including verbal and visual learning and short-term/working memory examined as exploratory analyses.


Secondary Outcome Measures :
  1. Alteration in symptom domain scores and event related potentials (ERPs) with PF-03463275 [ Time Frame: Change from Baseline at approximately 1 week ]
    To determine whether PF-03463275 impacts symptom domain scores and visual event related potentials (ERPs), analogous to long-term potentiation (LTP) with PF-03463275 treatment.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911676


Locations
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United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Deepak C D'Souza, MD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01911676    
Other Study ID Numbers: 1303011716
4UH3TR000960-02 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Cognition Disorders
Neurocognitive Disorders