- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03469089
Touchscreen-based Cognitive Tests in Healthy Volunteers
October 15, 2018 updated by: University of Eastern Finland
Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kuopio, Finland, 70210
- University of Eastern Finland, Clinical Research Centre, Brain Research Unit
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo/placebo
Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
|
0.9 % NaCl infusion solution
Other Names:
Placebo capsule for modafinil capsule
Other Names:
|
Experimental: Ketamine 0.58/placebo
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
|
Placebo capsule for modafinil capsule
Other Names:
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Other Names:
|
Experimental: Ketamine 0.58/modafinil
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
|
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Other Names:
Modafinil tablet 100 mg placed in a capsule
Other Names:
|
Experimental: Ketamine 0.31/placebo
Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
|
Placebo capsule for modafinil capsule
Other Names:
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ketamine-induced cognitive deficits
Time Frame: 15-60 min after initiation of ketamine or placebo infusion
|
Ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
|
15-60 min after initiation of ketamine or placebo infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of modafinil on ketamine-induced cognitive deficits
Time Frame: 15-60 min after initiation of ketamine or placebo infusion
|
The effect of modafinil on ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
|
15-60 min after initiation of ketamine or placebo infusion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ketamine plasma levels
Time Frame: 14 and 60 min after initiation of ketamine or placebo infusion
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Assessment of ketamine plasma levels
|
14 and 60 min after initiation of ketamine or placebo infusion
|
Brain-derived neurotrophic factor serum levels
Time Frame: 14 and 60 min after initiation of ketamine of placebo infusion
|
Assessment of Brain-derived neurotrophic factor serum levels
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14 and 60 min after initiation of ketamine of placebo infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Markus M Forsberg, PhD, University of Eastern Finland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2018
Primary Completion (Actual)
May 16, 2018
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
March 12, 2018
First Submitted That Met QC Criteria
March 12, 2018
First Posted (Actual)
March 19, 2018
Study Record Updates
Last Update Posted (Actual)
October 16, 2018
Last Update Submitted That Met QC Criteria
October 15, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Neurobehavioral Manifestations
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Ketamine
- Modafinil
Other Study ID Numbers
- REVISE28347
- 2017-004455-22 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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