A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
NCT ID: NCT02855411
Last Updated: 2020-01-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
35 participants
INTERVENTIONAL
2016-08-29
2016-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0.15 mg PF-04958242
Participants received 0.15 mg oral capsule, twice daily (BID) for 12 weeks
PF-04958242
Administered as specified in the treatment arm
0.5 mg PF-04958242
Participants received 0.5 mg oral capsule, twice daily (BID) for 12 weeks
PF-04958242
Administered as specified in the treatment arm
Placebo
Participants received matching placebo oral capsule, twice daily (BID) for 12 weeks
placebo
placebo, twice daily (BID) for 12 weeks, capsule
Interventions
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PF-04958242
Administered as specified in the treatment arm
placebo
placebo, twice daily (BID) for 12 weeks, capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
50 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Collaborative Neuroscience Network, LLC (Investigator Site File Location)
Garden Grove, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Excell Research, Inc
Oceanside, California, United States
NRC Research Institute
Orange, California, United States
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
San Diego, California, United States
Collaborative Neuroscience Network, LLC
Torrance, California, United States
Atlanta Center For Medical Research
Atlanta, Georgia, United States
Alexian Brothers Centers for Psychiatric Research
Hoffman Estates, Illinois, United States
Chinmay K. Patel, D.O.
Hoffman Estates, Illinois, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
CBH Health, LLC
Gaithersburg, Maryland, United States
Hassman Research Institute
Berlin, New Jersey, United States
CRI Worldwide, LLC
Marlton, New Jersey, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States
Pillar Clinical Research, LLC
Dallas, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Other Identifiers
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POC
Identifier Type: OTHER
Identifier Source: secondary_id
B1701019
Identifier Type: -
Identifier Source: org_study_id
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