A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers

Biogen

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Ketamine; Drug: PF-04958242; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01749098

B1701013

Details and patient eligibility

About

To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal learning and memory, episodic memory and spatial working memory in healthy volunteers.

Full description

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

Enrollment: 29 patients

Sex: Male

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects 21 - 45 years old.
• Able to read and write English as primary language.
• Subjects who are willing to comply with study procedures.

Exclusion criteria

• History of any substance abuse or dependence disorder meeting DSM-IV criteria and/or by SCID-NP within the past 12 months, with the exception of nicotine.
• Known sensitivity to ketamine
• Any history of DSM-IV Axis I psychiatric disorders, determined by SCID-NP interview or diagnoses in the view of the investigator.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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29 participants in 2 patient groups, including a placebo group

PF-04958242

Experimental group

Description:

PF-04958242 and ketamine

Treatment:

Drug: Ketamine

Drug: PF-04958242

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

Placebo and ketamine

Treatment:

Drug: Ketamine

Drug: Ketamine

Drug: Placebo