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A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Collaborative Neuroscience Network, LLC (Investigator Site File Location)
Garden Grove, California, 92845 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cognitive Impairment Associated With Schizophrenia (CIAS)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Otherwise healthy male and/or female subjects between the ages of 18 and 50 years,
inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition
(DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the
M.I.N.I 7.0 for Psychotic Disorders

- Evidence of stable schizophrenia symptomatology >=3 months (ie, no hospitalizations
for schizophrenia, no increase in level of psychiatric care due to worsening of
symptoms of schizophrenia).

- Subjects must be in ongoing maintenance atypical antipsychotic therapy (except
clozapine), on a stable treatment regimen for >=2 months prior to Baseline/Day 1,
including concomitant psychotropic treatments. Subjects should be on no more than 2
background antipsychotics.

- Subject must have an identified informant

- Subject must reside in a stable living situation for at least 12 weeks prior to
Screening.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of
the investigator.

- Subjects with a current DSM-5 diagnosis of major depressive episode, manic and
hypomanic episode, panic disorder, agoraphobia, social anxiety disorder,
obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety
disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the
investigator.

- Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia
nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic
Disorders or in the judgment of the investigator.

- Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use
disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I
7.0 for Psychotic Disorders interview and as determined by the investigator.

- Subjects with significant extrapyramidal symptoms which have not been stabilized with
anticholinergics.

NCT02855411
Pfizer
Terminated
A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)

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A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
A 12 Week, Phase 2, Randomized, Double-blind, Placebo Controlled, Parallel Group Study To Evaluate The Safety And Efficacy Of Pf-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (Cias)
The purpose of this study is to determine whether PF-04958242 is safe and effective in the treatment of cognitive dysfunction in schizophrenia subjects
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cognitive Impairment Associated With Schizophrenia (CIAS)
  • Drug: PF-04958242
    0.15 mg or 0.5 mg, twice daily (BID) for 12 weeks, capsule
  • Drug: placebo
    placebo, twice daily (BID) for 12 weeks, capsule
  • Experimental: 0.15 mg PF-04958242
    Intervention: Drug: PF-04958242
  • Experimental: 0.5 mg PF-04958242
    Intervention: Drug: PF-04958242
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
September 26, 2016
September 23, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Otherwise healthy male and/or female subjects between the ages of 18 and 50 years, inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the M.I.N.I 7.0 for Psychotic Disorders
  • Evidence of stable schizophrenia symptomatology >=3 months (ie, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).
  • Subjects must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for >=2 months prior to Baseline/Day 1, including concomitant psychotropic treatments. Subjects should be on no more than 2 background antipsychotics.
  • Subject must have an identified informant
  • Subject must reside in a stable living situation for at least 12 weeks prior to Screening.

Exclusion Criteria:

  • Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of the investigator.
  • Subjects with a current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
  • Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
  • Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I 7.0 for Psychotic Disorders interview and as determined by the investigator.
  • Subjects with significant extrapyramidal symptoms which have not been stabilized with anticholinergics.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02855411
B1701019
POC ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

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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1-800-718-1021

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[email protected]



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