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CompletedPhase 1

The Effect of Ketamine on Attentiveness

NCT01165294 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Closed to entry
Status
Not accepting participants
Phase 1
Phase
24
Target enrolment
Study sites

What it is testing

Summary

The objective of this study is to develop an exploratory design for future Proof-of-Concept trials which reliably and accurately measure the central nervous system (CNS) effects of potentially new drugs that oppose the effects of ketamine at a subanesthetic dose level given to healthy volunteers. A functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) performed simultaneously during a ketamine challenge will register the effects triggered by Ketamine.

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

  • Cerebral activation of ketamine as determined by functional MRI

    Measured over 25 and 40 minutes after end of bolus injection of ketamine/placebo

  • Cerebral activation of ketamine as determined by electroencephalogram (EEG) during an oddball-task

    Measured over 25 and 40 minutes after end of bolus injection of ketamine/placebo

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 35 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Normal ECG and safety assessments, or minor no-relevant deviations, at screening * Vital signs: systolic between 100 and 140 mmHg and diastolic between 50 and 90 mmHg and heart rate between 45 and 90 beats/min * No medication intake in the last four weeks * Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to adhere to the prohibitions and restrictions specified in the protocol * Negative drug screen Exclusion Criteria: * Participation in another clinical trial in the last 3 months * Significant allergies, allergic diathesis or known hypersensitivity for ketamine or its ingredients (ie, Benzethonium chloride) * History of or current significant respiratory disease, cardiovascular disease, endocrinological, gastrointestinal, neurological, glaucoma and known liver and kidney failure * Contraindications for an MRI being performed (claustrophobia, metal parts, pacemaker) * oxygen saturation pO2 \< 90 mmHg * Clinically significant abnormalities in ECG or laboratory values * Recent history (within previous 6 months) of alcohol or drug abuse * History of or current psychiatric diagnoses (DSM-IV, II) or neurological disorders * Relatives in first or second degree with a schizophrenic disorder * Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies * Signs of hyperthyroidism based on the determination of T3, T4 and TSH

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.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01165294 on ClinicalTrials.gov →

Last updated in the registry 2010-08-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits