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CompletedPhase 1

Ketamine Challenge Study With JNJ-40411813

NCT01101659 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Closed to entry
Status
Not accepting participants
Phase 1
Phase
40
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • 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

    Measured over 15 minutes after start of bolus injection of ketamine

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
MALE
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
—Neuss—Germany

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT01101659 on ClinicalTrials.gov →

Last updated in the registry 2014-04-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication

All 2 trials from Johnson & Johnson Pharmaceutical Research & Development, L.L.C. →