Touchscreen-based Cognitive Tests in Healthy Volunteers
NCT ID: NCT03469089
Last Updated: 2018-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
16 participants
INTERVENTIONAL
2018-03-12
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo/placebo
Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Placebo for ketamine
0.9 % NaCl infusion solution
Placebo for modafinil
Placebo capsule for modafinil capsule
Ketamine 0.58/placebo
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Ketamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Placebo for modafinil
Placebo capsule for modafinil capsule
Ketamine 0.58/modafinil
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Ketamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Modafinil
Modafinil tablet 100 mg placed in a capsule
Ketamine 0.31/placebo
Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
Ketamine 0.31
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
Placebo for modafinil
Placebo capsule for modafinil capsule
Interventions
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Ketamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Ketamine 0.31
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
Modafinil
Modafinil tablet 100 mg placed in a capsule
Placebo for ketamine
0.9 % NaCl infusion solution
Placebo for modafinil
Placebo capsule for modafinil capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
40 Years
MALE
Yes
Sponsors
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University of Eastern Finland
OTHER
Responsible Party
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Principal Investigators
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Markus M Forsberg, PhD
Role: STUDY_DIRECTOR
University of Eastern Finland
Locations
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University of Eastern Finland, Clinical Research Centre, Brain Research Unit
Kuopio, , Finland
Countries
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Other Identifiers
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2017-004455-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REVISE28347
Identifier Type: -
Identifier Source: org_study_id
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