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Unknown statusPhase 1

Touchscreen-based Cognitive Tests in Healthy Volunteers

NCT03469089 · University of Eastern Finland

Closed to entry
Status
Not accepting participants
Phase 1
Phase
16
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This phase Ib study aims to evaluate applicability of touchscreen-based cognitive test battery for assessment of ketamine-induced schizophrenia-like cognitive deficits in healthy volunteers. Additionally, the study aims to assess whether ketamine-induced cognitive deficits are reversed by modafinil using touchscreen-based test battery for testing of cognition.

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

  • Ketamine-induced cognitive deficits

    Measured over 15-60 min after initiation of ketamine or placebo infusion

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

20 Years to 40 Years
Ages
MALE
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Healthy Caucasian men aged 20-40 years * Body weight 50-100 kg * Body mass index 19-26 kg/cm2 * Normal physical examination including heart rate (HR; 50-90/min) blood pressure (BP; diastolic 65-90 and systolic 110-140) normal haematological and clinical chemistry variables normal ECG as judged by the investigator Exclusion Criteria: * Visual disability or red-green color blindness * History of mental health disorders as determined by self-reported a) physician-determined diagnoses of mental health disorders, except for nicotine and caffeine dependence, or history of suicide attempt; b) medications for mental health disorders * History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or neurological disorder * History of orthostatic syncope * History of head injury with sequelae * First-degree relative with a history of psychosis or epilepsy/seizure disorder or of a condition with risk of seizures * Current regular medication * Vaccination 2 weeks prior to study or during the study * Known or suspected allergy/hypersensitivity to any drug * History of regular alcohol consumption * Current substance dependence (excluding nicotine and caffeine). * Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day * Use of any medication or alcohol 24 hours before each study visit * Education less than high school * Clinically relevant symptoms of depression, anxiety or sleep disturbances * Donation of blood within 1 month prior to study * Participation in any study with an investigational product within 2 months prior to study * Clinical signs of suicidal or violent behaviour or psychotic symptoms

Where

1 study site

FacilityCityRegionCountry
University of Eastern Finland, Clinical Research Centre, Brain Research UnitKuopioFinland

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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NCT03469089 on ClinicalTrials.gov →

Last updated in the registry 2018-10-16. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication