Cognitive Impairments Associated With SchizophreniaPhase 2NCATSNCT01911676
Translational Neuroscience Optimization of GlyT1 Inhibitor
A Phase 2 study testing PF-03463275 in people with Cognitive Impairments Associated With Schizophrenia, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Cognitive Impairments Associated With Schizophrenia
- What is being tested?
- PF-03463275
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Connecticut Mental Health Center
New Haven, Connecticut, 06519
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
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.
- Being tested
- PF-03463275, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03463275Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PF-03463275 Active Dose #1 | Experimental | Active dose between 40mg Receives: Drug: PF-03463275 |
| PF-03463275 Active Dose #2 | Experimental | Active dose between 60mg Receives: Drug: PF-03463275 |
| Placebo | Placebo comparator | Placebo- no active dose of PF-03463275. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
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.
Measured: Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm.
Secondary outcomes (1)
Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275
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.
Measured: Change from Baseline at approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Impairments Associated With SchizophreniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Deepak C D'Souza, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911676
- Sponsor's protocol ID
- 1303011716
- Other IDs
- 4UH3TR000960-02
- Acronym
- NCATS
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2013
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Surti TS, Ranganathan M, Johannesen JK, Gueorguieva R, Deaso E, Kenney JG, Krystal JH, D'Souza DC. Randomized controlled trial of the glycine transporter 1 inhibitor PF-03463275 to enhance cognitive training and neuroplasticity in schizophrenia. Schizophr Res. 2023 Jun;256:36-43. doi: 10.1016/j.schres.2023.04.010. Epub 2023 May 2.
PubMed 37141764
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Neuroscience Optimization of GlyT1 Inhibitor
- ClinicalTrials.gov ID
- NCT01911676
- Acronym / sponsor ID
- NCATS / 1303011716
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Aug 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-03463275 Active Dose #1 | Experimental | Drug: PF-03463275Active dose between 40mg |
| PF-03463275 Active Dose #2 | Experimental | Drug: PF-03463275Active dose between 60mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo- no active dose of PF-03463275. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-03463275 | Drug | PF-03463275 Active Dose #1, PF-03463275 Active Dose #2 |
| Placebo | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275
Time frame: Change from Baseline at approximately 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37141764Surti TS, Ranganathan M, Johannesen JK, Gueorguieva R, Deaso E, Kenney JG, Krystal JH, D'Souza DC. Randomized controlled trial of the glycine transporter 1 inhibitor PF-03463275 to enhance cognitive training and neuroplasticity in schizophrenia. Schizophr Res. 2023 Jun;256:36-43. doi: 10.1016/j.schres.2023.04.010. Epub 2023 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak C D'Souza, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-03463275 in people with Cognitive Impairments Associated With Schizophrenia, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.