SchizophreniaPhase 1NCT00567203
A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
A Phase 1 study testing PF-3463275 in people with Schizophrenia, run by Pfizer at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- PF-3463275
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia
- In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
- Stable symptoms of schizophrenia for at least 3 months.
Who cannot join
- Subjects with a psychiatric disorder other than schizophrenia
- Substance dependence or abuse
- Women who have child bearing potential.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Willingboro, New Jersey, 08046
About this study
Official title: A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- PF-3463275, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-3463275Drug
PF-3463275 10mg
PF-3463275Drug
PF-3463275 25mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PF-3463275 |
| 2 | Experimental | Not described Receives: Drug: PF-3463275 |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the CNS Vital Signs Cognition Battery composite score
Measured: 6 days
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
Measured: 38 days
Pharmacokinetics of PF-3463275
Measured: 6 days
Secondary outcomes (2)
Positive and Negative Syndrome Scale (PANSS)
Measured: 6 days
Change from baseline in the CNS Vital Signs Cognition Battery domain scores
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567203
- Sponsor's protocol ID
- A9131004
- Status last verified
- Oct 2008
- First submitted
- 3 Dec 2007
- Last updated
- 2 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
- ClinicalTrials.gov ID
- NCT00567203
- Acronym / sponsor ID
- A9131004
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PF-3463275 |
| 2 | Experimental | Drug: PF-3463275 |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia
- In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
- Stable symptoms of schizophrenia for at least 3 months.
Key exclusion criteria (3 listed)
- Subjects with a psychiatric disorder other than schizophrenia
- Substance dependence or abuse
- Women who have child bearing potential.
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-3463275PF-3463275 10mg | Drug | 1 |
| PF-3463275PF-3463275 25mg | Drug | 2 |
| PlaceboPlacebo | Drug | 3 |
Primary outcome
Change from baseline in the CNS Vital Signs Cognition Battery composite score
Time frame: 6 days
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
Time frame: 38 days
Pharmacokinetics of PF-3463275
Time frame: 6 days
2 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: 6 days
Change from baseline in the CNS Vital Signs Cognition Battery domain scores
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-3463275 in people with Schizophrenia, run by Pfizer 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 3 inclusion and 3 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 2 Oct 2008. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in the CNS Vital Signs Cognition Battery composite score (time frame: 6 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2008.