Translational Neuroscience Optimization of GlyT1 Inhibitor (NCATS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT01911676
First received: July 10, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

This study involves an interlinked design to determine the dose associated with optimal activity and occupancy of the Glyt1I PF-03463275 in healthy subjects and schizophrenia subjects and to test this dose in combination with cognitive remediation in the treatment of cognitive impairments of Schizophrenia.


Condition Intervention Phase
Cognitive Impairments Associated With Schizophrenia
Drug: PF-03463275
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Translational Neuroscience Optimization of GlyT1 Inhibitor

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Receptor Occupancy after administration of PF-03463275 using PET. [ Time Frame: Change from Baseline in Receptor Occupancy at 6 weeks ] [ Designated as safety issue: No ]
    To examine the receptor occupancy associated with PF-03463275.


Secondary Outcome Measures:
  • Alteration in Pre-Frontal Cortex function with PF-03463275 [ Time Frame: Change from Baseline in Pre-frontal Cortex Function at 6 weeks ] [ Designated as safety issue: No ]
    To test whether PF-03463275 alters Pre-Frontal Cortex function during a working memory task in a dose-related manner, as measured with fMRI.


Other Outcome Measures:
  • Efficacy of PF03463275 on cognitive measures in Schizophrenic subjects. [ Time Frame: Change from Baseline in cognitive measures at 5 weeks ] [ Designated as safety issue: No ]
    To test the efficacy of PF03463275 on Cognitive Test Performance in subjects with Schizophrenia


Estimated Enrollment: 36
Study Start Date: August 2013
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-03463275 Active Dose#1
Active Dose between 10 mg
Drug: PF-03463275
Experimental: PF-03463275 Active Dose #2
Active dose between 20 mg
Drug: PF-03463275
Experimental: PF-03463275 Active Dose #3
Active dose between 40mg
Drug: PF-03463275
Placebo Comparator: Placebo
Placebo- no active dose of PF-03463275.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) Males or females 21 to 55 years of age (inclusive).
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911676

Contacts
Contact: Michelle Carbuto, BA (203) 376-3850 michelle.carbuto@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Michelle Carbuto, BA    203-376-3850    michelle.carbuto@yale.edu   
Principal Investigator: Deepak C D'Souza, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Deepak C D'Souza, MD Yale University
  More Information

No publications provided

Responsible Party: Deepak C. D'Souza, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01911676     History of Changes
Other Study ID Numbers: 1303011716
Study First Received: July 10, 2013
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cognition Disorders
Schizophrenia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 20, 2014