Translational Neuroscience Optimization of GlyT1 Inhibitor (NCATS)
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ClinicalTrials.gov Identifier: NCT01911676 |
Recruitment Status :
Completed
First Posted : July 30, 2013
Results First Posted : February 27, 2023
Last Update Posted : February 27, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognitive Impairments Associated With Schizophrenia | Drug: PF-03463275 Drug: Placebo | Phase 2 |
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 |

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.
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Drug: Placebo |
- 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.
- 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.

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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 |
Documents provided by 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 |
Results First Posted: | February 27, 2023 |
Last Update Posted: | February 27, 2023 |
Last Verified: | February 2023 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |