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

Ketamine

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.

Intervention / Treatment

  • Ketamine and Org 25935 (DRUG)
    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 and Ketamine (DRUG)
    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)

Condition or Disease

  • Healthy

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 15 (ACTUAL)
    Funded by: Other|Industry
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 22, 2008 ACTUAL
    Primary Completion: Mar 09, 2009 ACTUAL
    Completion Date: Mar 09, 2009 ACTUAL
    Study First Posted: Jun 18, 2008 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 02, 2022

    Sponsors / Collaborators

    Lead Sponsor: Yale University
    Responsible Party: N/A

    Location

    West Haven, Connecticut, USA

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • Attenuation of ketamine-induced cognitive deficits by Org 25935 +20 to +100 minutes
    Secondary Outcomes
    • Attenuation of ketamine-induced schizophrenia-like psychotic symptoms, perceptual alterations, subjective high and deficits in attention and working memory by Org 25935. 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. 0 to +100 minutes

    More Details

    NCT Number: NCT00700076
    Other IDs: 0701002174
    Study URL: https://clinicaltrials.gov/study/NCT00700076
    Last updated: Sep 29, 2023