DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017