A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Condition: Cognitive Impairment Associated With Schizophrenia (CIAS)
MeSH terms: Schizophrenia; Cognitive Dysfunction
Intervention: PF-04958242; placebo
Intervention description: Administered as specified in the treatment arm; placebo, twice daily (BID) for 12 weeks, capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether PF-04958242 is safe and effective in the
      treatment of cognitive dysfunction in schizophrenia subjects
    

Eligibility criteria:

        Key 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.

        Key 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.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply