An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia

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NCT01939548

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Study Location
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226, United States
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Contact
1-800-718-1021
[email protected]
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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
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
  • Drug: PF-02545920
    PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit
    Other Name: 5 mg BID
  • Drug: Placebo
    Placebo BID until the Week 12 visit
  • Drug: PF-02545920
    PF-02545920 5 mg BID x 7 days, then 10 mg BID x 7 days, then 15 mg BID until the Week 12 visit
    Other Name: 15 mg BID
Study Arms  ICMJE
  • Experimental: PF-02545920 (5mg)
    Intervention: Drug: PF-02545920
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-02545920 (15mg)
    Intervention: Drug: PF-02545920
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
 (submitted: January 8, 2015)		240
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)		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:

  • 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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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