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Translational Neuroscience Optimization of GlyT1 Inhibitor (NCATS)

This study is currently recruiting participants.
Verified June 2017 by Deepak C. D'Souza, Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01911676
First Posted: July 30, 2013
Last Update Posted: June 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
  Purpose
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 Intervention Phase
Cognitive Impairments Associated With Schizophrenia Drug: PF-03463275 Drug: Placebo Phase 2

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

Resource links provided by NLM:


Further study details as provided by Deepak C. D'Souza, Yale University:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 90
Study Start Date: August 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (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
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


Contacts
Contact: Emma Deaso, BA 203-974-7489 emma.deaso@yale.edu
Contact: Kimberlee Forselius-Bielen, BS 203-974-7540 kimberlee.forselius@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Emma Deaso, BA    203-974-7489    emma.deaso@yale.edu   
Contact: Kimberlee Forselius-Bielen, BS    203-974-7540    kimberlee.forselius@yale.edu   
Principal Investigator: Deepak C D'Souza, MD         
Sub-Investigator: Mohini Ranganathan, MD         
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Christina Luddy, BS    203-932-5711 ext 4549    christina.luddy@yale.edu   
Principal Investigator: Deepak C D'Souza, MD         
Sub-Investigator: Mohini Ranganathan, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Deepak C D'Souza, MD Yale University
  More Information

Responsible Party: Deepak C. D'Souza, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01911676     History of Changes
Other Study ID Numbers: 1303011716
First Submitted: July 10, 2013
First Posted: July 30, 2013
Last Update Posted: June 23, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders