Touchscreen-based Cognitive Tests in Healthy Volunteers
Primary Purpose
Cognitive Symptom, Schizophrenia
Status
Unknown status
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Ketamine 0.58
Ketamine 0.31
Modafinil
Placebo for ketamine
Placebo for modafinil
Sponsored by
About this trial
This is an interventional basic science trial for Cognitive Symptom focused on measuring schizophrenia, cognitive symptom, healthy volunteer, cognitive testing
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
Sites / Locations
- University of Eastern Finland, Clinical Research Centre, Brain Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo/placebo
Ketamine 0.58/placebo
Ketamine 0.58/modafinil
Ketamine 0.31/placebo
Arm Description
Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
Outcomes
Primary Outcome Measures
Ketamine-induced cognitive deficits
Ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
Secondary Outcome Measures
Effect of modafinil on ketamine-induced cognitive deficits
The effect of modafinil on ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
Full Information
NCT ID
NCT03469089
First Posted
March 12, 2018
Last Updated
October 15, 2018
Sponsor
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT03469089
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Eastern Finland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Symptom, Schizophrenia
Keywords
schizophrenia, cognitive symptom, healthy volunteer, cognitive testing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals
Masking
ParticipantInvestigator
Masking Description
Double blinded
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo/placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Arm Title
Ketamine 0.58/placebo
Arm Type
Experimental
Arm Description
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Arm Title
Ketamine 0.58/modafinil
Arm Type
Experimental
Arm Description
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Arm Title
Ketamine 0.31/placebo
Arm Type
Experimental
Arm Description
Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.58
Other Intervention Name(s)
Ketalar
Intervention Description
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.31
Other Intervention Name(s)
Ketalar
Intervention Description
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Modafinil Orion
Intervention Description
Modafinil tablet 100 mg placed in a capsule
Intervention Type
Drug
Intervention Name(s)
Placebo for ketamine
Other Intervention Name(s)
Placebo
Intervention Description
0.9 % NaCl infusion solution
Intervention Type
Drug
Intervention Name(s)
Placebo for modafinil
Other Intervention Name(s)
Placebo
Intervention Description
Placebo capsule for modafinil capsule
Primary Outcome Measure Information:
Title
Ketamine-induced cognitive deficits
Description
Ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
Time Frame
15-60 min after initiation of ketamine or placebo infusion
Secondary Outcome Measure Information:
Title
Effect of modafinil on ketamine-induced cognitive deficits
Description
The effect of modafinil on ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
Time Frame
15-60 min after initiation of ketamine or placebo infusion
Other Pre-specified Outcome Measures:
Title
Ketamine plasma levels
Description
Assessment of ketamine plasma levels
Time Frame
14 and 60 min after initiation of ketamine or placebo infusion
Title
Brain-derived neurotrophic factor serum levels
Description
Assessment of Brain-derived neurotrophic factor serum levels
Time Frame
14 and 60 min after initiation of ketamine of placebo infusion
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus M Forsberg, PhD
Organizational Affiliation
University of Eastern Finland
Official's Role
Study Director
Facility Information:
Facility Name
University of Eastern Finland, Clinical Research Centre, Brain Research Unit
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Touchscreen-based Cognitive Tests in Healthy Volunteers
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