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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226 United States
Contact
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
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.

NCT01939548
Pfizer
Terminated
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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An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Experimental: PF-02545920 (5mg)
    Intervention: Drug: PF-02545920
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-02545920 (15mg)
    Intervention: Drug: PF-02545920
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.
 
Terminated
240
October 2014
October 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01939548
A8241019
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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