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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700076
First Posted: June 18, 2008
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Organon
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
  Purpose
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 Intervention Phase
Healthy Drug: Ketamine and Org 25935 Drug: Placebo and Ketamine Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Deepak C. D'Souza, Yale University:

Primary Outcome Measures:
  • Attenuation of ketamine-induced cognitive deficits by Org 25935 [ Time Frame: +20 to +100 minutes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 18
Study Start Date: December 2006
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00700076     History of Changes
Other Study ID Numbers: 0701002174
First Submitted: June 13, 2008
First Posted: June 18, 2008
Last Update Posted: June 23, 2017
Last Verified: June 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