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:
Yale University
Collaborator:
Organon
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00700076
First received: June 13, 2008
Last updated: March 25, 2013
Last verified: March 2013
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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: Double Blind (Subject, Caregiver, 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 Yale University:
Primary Outcome Measures:
- Attenuation of ketamine-induced cognitive deficits by Org 25935 [ Time Frame: +20 to +100 minutes ] [ Designated as safety issue: No ]
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 ] [ 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 ]
| Estimated Enrollment: | 18 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Deepak C. D'Souza, Associate Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00700076 History of Changes |
| Other Study ID Numbers: | 0701002174 |
| Study First Received: | June 13, 2008 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Yale University:
|
ORG 25935 Ketamine healthy subjects |
Additional relevant MeSH terms:
|
Ketamine Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013