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

Yale University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo and Ketamine; Drug: Ketamine and Org 25935

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00700076

0701002174

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Ketamine and Org 25935

2

Placebo Comparator group

Treatment:

Drug: Placebo and Ketamine