UnknownPhase 1ketamine
Touchscreen-based Cognitive Tests in Healthy Volunteers
Sponsored by University of Eastern Finland
NCT ID
NCT03469089
Target Enrollment
16 participants
Start Date
2018-03-12
Est. Completion
2019-12-31
About This Study
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.
Conditions Studied
Interventions
- •Ketamine 0.58
- •Ketamine 0.31
- •Modafinil
- •Placebo for ketamine
- •Placebo for modafinil
Eligibility
Sex:MALE
Age:20 Years - 40 Years
Healthy Volunteers:Yes
View full eligibility 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
Study Locations (1)
University of Eastern Finland, Clinical Research Centre, Brain Research Unit
Kuopio, Finland