Status:
UNKNOWN
Touchscreen-based Cognitive Tests in Healthy Volunteers
Lead Sponsor:
University of Eastern Finland
Conditions:
Cognitive Symptom
Schizophrenia
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief 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. Additiona...
Detailed Description
Ketamine-induced schizophrenia-like cognitive deficits in healthy volunteers are measured by using touchscreen-based cognitive tests. In addition, the study aims to assess whether ketamine-induced cog...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03469089
Start Date
March 12 2018
End Date
December 31 2019
Last Update
October 16 2018
Active Locations (1)
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1
University of Eastern Finland, Clinical Research Centre, Brain Research Unit
Kuopio, Finland, 70210