Translational Neuroscience Optimization of GlyT1 Inhibitor (NCATS)
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ClinicalTrials.gov Identifier: NCT01911676 |
Recruitment Status :
Active, not recruiting
First Posted : July 30, 2013
Last Update Posted : January 7, 2021
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Condition or disease | Intervention/treatment | Phase |
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Cognitive Impairments Associated With Schizophrenia | Drug: PF-03463275 Drug: Placebo | Phase 2 |
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 2021 |
Estimated Study Completion Date : | December 2021 |

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

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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 |
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

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
United States, Connecticut | |
Connecticut Mental Health Center | |
New Haven, Connecticut, United States, 06519 | |
VA Connecticut Healthcare System | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Deepak C D'Souza, MD | Yale University |
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: | January 7, 2021 |
Last Verified: | January 2021 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |