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