Schizophrenia Clinical Trial
Official title:
A Double-Blind, 2-Way Crossover Study to Investigate the Effects of JNJ-40411813 on Ketamine-Induced Alterations in Neuropsychiatric Performance
The objective of this study is to investigate whether JNJ-40411813 versus placebo reduces psychosis-like symptoms, induced by infusion of a low dose of ketamine. Effects of JNJ-40411813 on ketamine-induced symptoms will be evaluated about 3 hours after a single oral dose when the concentration of JNJ-40411813 in the blood is at its maximum and up to 24 hours after dose administration to assess the duration of a potential JNJ-40411813 effect.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2010 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Body mass index (BMI) between 18 and 30 kg/m2 - Nonsmokers - Healthy on the basis of a psychiatric examination according to the MINI screen - Healthy on the basis of clinical laboratory tests performed at screening - Healthy on the basis of physical examination, vital signs (including standing blood pressure and heart rate) or 12 lead ECG at Screening Exclusion Criteria: - Having a contra-indication for the use of ketamine - Significant history of or current psychiatric or neurological illness - Positive urine screen for drugs of abuse at Screening or admission - Positive alcohol breath test at Screening or admission - History of alcohol or drug abuse |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate the effect of JNJ- 40411813 on ketamine-induced positive psychotic symptoms based on 4 items of the brief psychiatric rating scale (BPRS) in healthy male volunteers | 15 minutes after start of bolus injection of ketamine | No | |
Secondary | Investigate the effects of JNJ 40411813 on ketamine-induced negative symptoms,based on 3 items of the BPRS, dissociative effects (based on the 5-dimensions altered state of consciousness (5D-ASC), and cognitive performance | 15 min, 30 to 60 min after start of bolus injection of ketamine and at the end of ketamine infusion | No | |
Secondary | Investigate the duration of action and the concentration-effect relationship of JNJ 40411813 | 3, 12 and 24 hours after dosing of JNJ 40411813 | No | |
Secondary | Investigate the safety, tolerability, and pharmacokinetics of JNJ 40411813 in healthy volunteers | During each Period on Days 1, 2 and 3 (if applicable) and at follow up | No |
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