Overview

This trial is active, not recruiting.

Condition healthy
Treatments ketamine and org 25935, placebo and ketamine
Phase phase 1
Sponsor Yale University
Collaborator Organon
Start date December 2006
End date December 2016
Trial size 18 participants
Trial identifier NCT00700076, 0701002174

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
ketamine and org 25935
Oral administration of Org 25935 16 mg and intravenous administration of ketamine (0.23 mg/kg bolus over 1 minute, followed by 0.58 mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 69 minutes)
(Placebo Comparator)
placebo and ketamine
Oral administration of placebo and intravenous administration of ketamine (0.23 mg/kg bolus over 1 minute, followed by 0.58 mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 69 minutes)

Primary Outcomes

Measure
Attenuation of ketamine-induced cognitive deficits by Org 25935
time frame: +20 to +100 minutes

Secondary Outcomes

Measure
Attenuation of ketamine-induced schizophrenia-like psychotic symptoms, perceptual alterations, subjective high and deficits in attention and working memory by Org 25935.
time frame: 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.
time frame: 0 to +100 minutes

Eligibility Criteria

Male participants from 18 years up to 55 years old.

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.

Additional Information

Official title Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Principal investigator Deepak C D'Souza, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Yale University.