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Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT00700076
Recruitment Status : Active, not recruiting
First Posted : June 18, 2008
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Organon
Information provided by (Responsible Party):
Deepak C. D'Souza, 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ketamine and Org 25935 Drug: Placebo and Ketamine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Study Start Date : December 2006
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: 1 Drug: 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: 2 Drug: 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 Outcome Measures :
  1. Attenuation of ketamine-induced cognitive deficits by Org 25935 [ Time Frame: +20 to +100 minutes ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700076


Locations
United States, Connecticut
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Organon
Investigators
Principal Investigator: Deepak C D'Souza, M.D. Yale University, School of Medicine, Department of Psychiatry

Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00700076     History of Changes
Other Study ID Numbers: 0701002174
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Keywords provided by Deepak C. D'Souza, Yale University:
ORG 25935
Ketamine
healthy subjects

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action