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



Status:Terminated
Conditions:Cognitive Studies, Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:10/6/2017
Start Date:August 2016
End Date:September 26, 2016

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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


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.
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16
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1066
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San Diego, CA
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Bellevue, Washington 98007
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Berlin, New Jersey
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Dallas, Texas 75243
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Gaithersburg, Maryland 20877
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Garden Grove, CA
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Garden Grove, California 92845
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1786 Moon Lake Boulevard
Hoffman Estates, Illinois 60169
1704
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1786 Moon Lake Boulevard
Hoffman Estates, Illinois 60169
1704
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Lake Charles, Louisiana 70601
1954
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Marlton, New Jersey 08053
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Memphis, Tennessee 38119
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Oceanside, California 92056
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Orange, California 92868
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Torrance, California 90502
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