Touchscreen-based Cognitive Tests in Healthy Volunteers

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Eastern Finland
• Treatments: Armodafinil; Ketamine; Modafinil

Criteria

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