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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 : Completed
First Posted : July 30, 2013
Results First Posted : February 27, 2023
Last Update Posted : February 27, 2023
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)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Translational Neuroscience Optimization of GlyT1 Inhibitor
Study Start Date : August 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

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. Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) [ Time Frame: Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm. ]
    To test the efficacy of PF-03463275 on cognitive test performance specifically, the MCCB composite score was used. The MCCB consists of 10 tests and provides standard scores and percentiles for each of seven cognitive domains and an overall composite score. Domains assessed include: speed of processing, attention/vigilance, working memory (verbal and visual), verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB overall composite score is presented as a T-score. The range of T-scores is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning.


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. A more positive value reflects a better outcome - there is no established range to report. A Z-score of 0 indicates the mean score. A positive z-score indicates the mean is higher than average.


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
  Study Documents (Full-Text)

Documents provided by Yale University:
Study Protocol  [PDF] May 28, 2021
Statistical Analysis Plan  [PDF] May 28, 2021
Informed Consent Form  [PDF] July 12, 2018

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
Results First Posted: February 27, 2023
Last Update Posted: February 27, 2023
Last Verified: February 2023
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders