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

Biogen

Status and phase: Terminated; Phase 2

Conditions: Cognitive Impairment Associated With Schizophrenia (CIAS)

Treatments: Drug: PF-04958242; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02855411

B1701019

POC (Other Identifier)

Details and patient eligibility

About

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

Full description

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Enrollment: 35 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 3 patient groups, including a placebo group

0.15 mg PF-04958242

Experimental group

Description:

Participants received 0.15 mg oral capsule, twice daily (BID) for 12 weeks

Treatment:

Drug: PF-04958242

0.5 mg PF-04958242

Experimental group

Description:

Participants received 0.5 mg oral capsule, twice daily (BID) for 12 weeks

Treatment:

Drug: PF-04958242

Placebo

Placebo Comparator group

Description:

Participants received matching placebo oral capsule, twice daily (BID) for 12 weeks

Treatment:

Drug: placebo