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:
Collaborator:
Organon
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00700076
First received: June 13, 2008
Last updated: September 13, 2013
Last verified: March 2013

June 13, 2008
September 13, 2013
December 2006
December 2013   (final data collection date for primary outcome measure)
Attenuation of ketamine-induced cognitive deficits by Org 25935 [ Time Frame: +20 to +100 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00700076 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • 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)
  • 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)
  • Active Comparator: 1
    Intervention: Drug: Ketamine and Org 25935
  • Placebo Comparator: 2
    Intervention: Drug: Placebo and Ketamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00700076
0701002174
Yes
Deepak C. D'Souza, Yale University
Yale University
Organon
Principal Investigator: Deepak C D'Souza, M.D. Yale University, School of Medicine, Department of Psychiatry
Yale University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP