Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00700076
- Lead Sponsor
- Yale University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Ketamine and Org 25935 - 2 Placebo and Ketamine -
- Primary Outcome Measures
Name Time Method Attenuation of ketamine-induced cognitive deficits by Org 25935 +20 to +100 minutes
- Secondary Outcome Measures
Name Time Method Attenuation of ketamine-induced schizophrenia-like psychotic symptoms, perceptual alterations, subjective high and deficits in attention and working memory by Org 25935. 0 to +100 minutes 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. 0 to +100 minutes
Trial Locations
- Locations (1)
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
🇺🇸West Haven, Connecticut, United States