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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: PF-04958242; Drug: Placebo; Drug: Ketamine

• Registration Number: NCT01749098
• Lead Sponsor: Biogen

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-04958242	PF-04958242	PF-04958242 and ketamine
Placebo	Placebo	Placebo and ketamine
Placebo	Ketamine	Placebo and ketamine
PF-04958242	Ketamine	PF-04958242 and ketamine

Primary Outcome Measures

Name	Time	Method
Test score on the Hopkins Verbal Learning Test - Immediate Recall	Day 5

Secondary Outcome Measures

Name	Time	Method
Test score on the CogState One Card Learning test	Day 5
Test score on the Weschler Digit Span Test	Day 5
Test score on the CogState N-back test	Day 5
Test score on the CogState Spatial Working memory test	Day 5
Test score on the Hopkins Verbal Learning test - Delayed Recall	Day 5
Retrospective rating on the Positive and Negative Syndrome Scale -modified scale'	Day 5

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 West Haven, Connecticut, United States