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Touchscreen-based Cognitive Tests in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03469089
Recruitment Status : Active, not recruiting
First Posted : March 19, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Eastern Finland

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.

Condition or disease Intervention/treatment Phase
Cognitive Symptom Schizophrenia Drug: Ketamine 0.58 Drug: Ketamine 0.31 Drug: Modafinil Drug: Placebo for ketamine Drug: Placebo for modafinil Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals
Masking: Double (Participant, Investigator)
Masking Description: Double blinded
Primary Purpose: Basic Science
Official Title: Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : May 16, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo/placebo
Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Drug: Placebo for ketamine
0.9 % NaCl infusion solution
Other Name: Placebo

Drug: Placebo for modafinil
Placebo capsule for modafinil capsule
Other Name: Placebo

Experimental: Ketamine 0.58/placebo
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Drug: Ketamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Other Name: Ketalar

Drug: Placebo for modafinil
Placebo capsule for modafinil capsule
Other Name: Placebo

Experimental: Ketamine 0.58/modafinil
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Drug: Ketamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Other Name: Ketalar

Drug: Modafinil
Modafinil tablet 100 mg placed in a capsule
Other Name: Modafinil Orion

Experimental: Ketamine 0.31/placebo
Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
Drug: Ketamine 0.31
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
Other Name: Ketalar

Drug: Placebo for modafinil
Placebo capsule for modafinil capsule
Other Name: Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Ketamine plasma levels [ Time Frame: 14 and 60 min after initiation of ketamine or placebo infusion ]
    Assessment of ketamine plasma levels

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469089


Locations
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Finland
University of Eastern Finland, Clinical Research Centre, Brain Research Unit
Kuopio, Finland, 70210
Sponsors and Collaborators
University of Eastern Finland
Investigators
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Study Director: Markus M Forsberg, PhD University of Eastern Finland

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Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT03469089     History of Changes
Other Study ID Numbers: REVISE28347
2017-004455-22 ( EudraCT Number )
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Eastern Finland:
schizophrenia
cognitive symptom
healthy volunteer
cognitive testing

Additional relevant MeSH terms:
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Ketamine
Schizophrenia
Neurobehavioral Manifestations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Modafinil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers