Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Ketamine and Org 25935 (Drug); Placebo and Ketamine (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Deepak C D'Souza, M.D., Principal Investigator, Affiliation: Yale University, School of Medicine, Department of Psychiatry
Summary
Org 25935 is a new putative antipsychotic agent developed by N. V. Organon. The primary
objective of this study is to investigate the effect of Org 25935 on ketamine-induced
impairments in immediate recall.
Clinical Details
Official title: Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Attenuation of ketamine-induced cognitive deficits by Org 25935
Secondary outcome: Attenuation of ketamine-induced schizophrenia-like psychotic symptoms, perceptual alterations, subjective high and deficits in attention and working memory by Org 25935.Investigation of interaction of polymorphisms of candidate genes e.g., BDNF, COMT with the effect of Org 25935 on ketamine induced psychotomimetic and amnestic deficits.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Male, 18 - 55 years
Exclusion Criteria:
- History of sensitivity/idiosyncrasy to the drugs used in the study or chemically
related compounds or excipients which may be employed in the study or to any other
unknown drug used in the past.
Locations and Contacts
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine, West Haven, Connecticut 06516, United States
Additional Information
Starting date: December 2006
Last updated: September 24, 2014
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