ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01911676
Recruitment Status : Recruiting
First Posted : July 30, 2013
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: July 30, 2013    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

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