An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
NCT01939548
Last updated date
ABOUT THIS STUDY
This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of
sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment
period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change
in symptoms for PF-02545920 from baseline compared to placebo.
Study Location
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Psychiatrically stable subjects with schizophrenia who have had a suboptimal response to current treatment
- Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
- Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- History of seizures or of a condition with risk of seizures.
- Subjects with schizophrenia that have not responded at all to current treatment.
- Pregnant or nursing females, and females of child bearing potential.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia | |||
| Official Title ICMJE | A 12-week , Randomized, Phase 2, Double-blind, Parallel-group Study Of Two Dose Levels Of Pf-02545920 Compared To Placebo In The Adjunctive Treatment Of Outpatients With Sub-optimally Controlled Symptoms Of Schizophrenia | |||
| Brief Summary | This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 from baseline compared to placebo. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Schizophrenia | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Targum SD, Cara Pendergrass J, Toner C, Zumpano L, Rauh P, DeMartinis N. Impact of BPRS interview length on ratings reliability in a schizophrenia trial. Eur Neuropsychopharmacol. 2015 Mar;25(3):312-8. doi: 10.1016/j.euroneuro.2014.11.023. Epub 2014 Dec 13. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 240 | |||
| Original Estimated Enrollment ICMJE | 249 | |||
| Actual Study Completion Date ICMJE | October 2014 | |||
| Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01939548 | |||
| Other Study ID Numbers ICMJE | A8241019 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||