SchizophreniaPhase 2NCT00977522
A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia
A Phase 2 study testing PF-03463275 in people with Schizophrenia, run by Pfizer at 37 sites in United States.
Trial summary
This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with 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-03463275
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 37 sitesUnited States
- Study dates
- Nov 2009to Sep 2010
- Phase
- Phase 2
- 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
- Subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase.
- Subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. Subjects must be on a stable medication treatment regimen for at least 2 months.
- Evidence of stable symptomatology at least 3 months.
Who cannot join
- Female subjects who are pregnant or breastfeeding.
- Subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results.
- Subjects who have DSM IV defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Austin, Texas, 78731
Pfizer Investigational Site
Austin, Texas, 78754
Pfizer Investigational Site
Bellaire, Texas, 77401
Pfizer Investigational Site
Cerritos, California, 90703
Pfizer Investigational Site
Chula Vista, California, 91910
Pfizer Investigational Site
Decatur, Georgia, 30333
Pfizer Investigational Site
Edmond, Oklahoma, 73034
Pfizer Investigational Site
Escondido, California, 92025
Pfizer Investigational Site
Flowood, Mississippi, 39232
Pfizer Investigational Site
Fresh Meadows, New York, 11366
Pfizer Investigational Site
Garden Grove, California, 92845
Pfizer Investigational Site
Glendale, California, 91436
Pfizer Investigational Site
Holliswood, New York, 11423
Pfizer Investigational Site
Houston, Texas, 77008
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Long Beach, California, 90805
Pfizer Investigational Site
Long Beach, California, 90808
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73116
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Park Ridge, Illinois, 60068
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19139
Pfizer Investigational Site
Runnemede, New Jersey, 08078
Pfizer Investigational Site
Staten Island, New York, 10304
Pfizer Investigational Site
Staten Island, New York, 10305
Pfizer Investigational Site
Toms River, New Jersey, 08755
Pfizer Investigational Site
Torrance, California, 90502
Pfizer Investigational Site
Washington D.C., District of Columbia, 20016
Pfizer Investigational Site
Washington D.C., District of Columbia, 20036
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Wichita, Kansas, 67211
Pfizer Investigational Site
Willingboro, New Jersey, 08046
About this study
Official title: A Randomized Phase 2, Double-Blind, Placebo-Controlled, Multi-Center Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia Treated With A Stable Dose Of A Second Generation Antipsychotic
This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.
Read the detailed description
The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.
- Conditions
- Schizophrenia
- Being tested
- PF-03463275, Placebo
- Keywords
- schizophrenia negative symptoms adjunctive
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03463275Drug
30 mg Controlled Release tablet BID for 12 weeks
PlaceboDrug
Placebo tablet BID
| Study group | Role | What they receive |
|---|---|---|
| PF-03463275 | Experimental | Not described Receives: Drug: PF-03463275 |
| Placebo | 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 Positive and Negative Syndrome Scale (PANSS) Negative Subscale score
Measured: 12 weeks
Vital Signs (Blood pressure, heart rate)
Measured: 15 weeks
ECG
Measured: 15 weeks
Safety laboratory assessments
Measured: 15 weeks
Adverse events
Measured: 15 weeks
Secondary outcomes (12)
Change from baseline in Quality of Life Scale (QLS)
Measured: 12 weeks
Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores
Measured: 12 weeks
Change from baseline in PANSS Total
Measured: 12 weeks
Change from baseline in PANSS Positive Subscale
Measured: 12 weeks
Change from baseline in PANSS General Subscale
Measured: 12 weeks
Change from baseline in Clinical Global Impression Severity (CGI-S)
Measured: 12 weeks
Clinical Global Impression Improvement (CGI-I) Total Score
Measured: 12 weeks
Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified
Measured: 12 weeks
Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale
Measured: 12 weeks
Change from baseline in Global Assessment of Functioning
Measured: 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: 15 weeks
Pharmacokinetic assays
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: See termination reason in detailed description.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977522
- Sponsor's protocol ID
- A9131005
- Status last verified
- Feb 2012
- First submitted
- 14 Sep 2009
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2, Double-Blind, Placebo-Controlled, Multi-Center Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia Treated With A Stable Dose Of A Second Generation Antipsychotic
- ClinicalTrials.gov ID
- NCT00977522
- Acronym / sponsor ID
- A9131005
- Conditions
- Schizophrenia
- Keywords
- schizophrenia negative symptoms adjunctive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 207 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Sep 2009 (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.
This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.
Detailed description
The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-03463275 | Experimental | Drug: PF-03463275 |
| Placebo | 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)
- Subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase.
- Subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. Subjects must be on a stable medication treatment regimen for at least 2 months.
- Evidence of stable symptomatology at least 3 months.
Key exclusion criteria (3 listed)
- Female subjects who are pregnant or breastfeeding.
- Subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results.
- Subjects who have DSM IV defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.
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-0346327530 mg Controlled Release tablet BID for 12 weeks | Drug | PF-03463275 |
| PlaceboPlacebo tablet BID | Drug | Placebo |
Primary outcome
Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score
Time frame: 12 weeks
Vital Signs (Blood pressure, heart rate)
Time frame: 15 weeks
ECG
Time frame: 15 weeks
Safety laboratory assessments
Time frame: 15 weeks
Adverse events
Time frame: 15 weeks
12 secondary outcomes
Change from baseline in Quality of Life Scale (QLS)
Time frame: 12 weeks
Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores
Time frame: 12 weeks
Change from baseline in PANSS Total
Time frame: 12 weeks
Change from baseline in PANSS Positive Subscale
Time frame: 12 weeks
Change from baseline in PANSS General Subscale
Time frame: 12 weeks
Change from baseline in Clinical Global Impression Severity (CGI-S)
Time frame: 12 weeks
Clinical Global Impression Improvement (CGI-I) Total Score
Time frame: 12 weeks
Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified
Time frame: 12 weeks
Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale
Time frame: 12 weeks
Change from baseline in Global Assessment of Functioning
Time frame: 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 15 weeks
Pharmacokinetic assays
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
- 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
37 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 Schizophrenia, run by Pfizer at 37 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: stopped early, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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?
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
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 Positive and Negative Syndrome Scale (PANSS) Negative Subscale score (time frame: 12 weeks). The study lists 5 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 7 Feb 2012.