Clinical trial NCT03469089: Touchscreen-based Cognitive Tests in Healthy Volunteers
Official title: Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cognitive Symptom
Schizophrenia
Keywords: schizophrenia
cognitive symptom
healthy volunteer
cognitive testing
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals
Primary purpose: BASIC_SCIENCE

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. Additionally, the study aims to assess whether ketamine-induced cognitive deficits are reversed by modafinil using touchscreen-based test battery for testing of cognition.

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 cognitive deficits detected by touchscreen-based cognitive tests are reversed by modafinil.

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

Primary outcomes:
measure: Ketamine-induced cognitive deficits
timeFrame: 15-60 min after initiation of ketamine or placebo infusion
Secondary outcomes:
measure: Effect of modafinil on ketamine-induced cognitive deficits
timeFrame: 15-60 min after initiation of ketamine or placebo infusion
Other outcomes:
measure: Ketamine plasma levels
timeFrame: 14 and 60 min after initiation of ketamine or placebo infusion
measure: Brain-derived neurotrophic factor serum levels
timeFrame: 14 and 60 min after initiation of ketamine of placebo infusion
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland, Clinical Research Centre, Brain Research Unit
Study officials:
affiliation: University of Eastern Finland
name: Markus M Forsberg, PhD
role: STUDY_DIRECTOR
References: