A Phase 1 interventional study of PF-04958242 and Ketamine in Schizophrenia, sponsored by Biogen. Completed at 2 sites in United States. Open to male participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by Biogen · Phase 1, Interventional, and Basic science
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.
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 29 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PF-04958242 and ketamine
Drug: PF-04958242 · Drug: Ketamine
Placebo and ketamine
Drug: Placebo · Drug: Ketamine
PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5
At 60 minutes after the 0.25 mg dose of PF-04958242 on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.
Placebo capsule orally administered on Days 1 - 5
At 60 minutes after Placebo on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.
Test score on the Hopkins Verbal Learning Test - Immediate Recall
Time frame: Day 5
Test score on the Weschler Digit Span Test
Time frame: Day 5
Test score on the CogState N-back test
Time frame: Day 5
Test score on the CogState Spatial Working memory test
Time frame: Day 5
Test score on the CogState One Card Learning test
Time frame: Day 5
Test score on the Hopkins Verbal Learning test - Delayed Recall
Time frame: Day 5
Retrospective rating on the Positive and Negative Syndrome Scale -modified scale'
Time frame: Day 5
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Biogen