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Touchscreen-based Cognitive Tests in Healthy Volunteers

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

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE March 19, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE March 12, 2018
Actual Primary Completion Date May 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2018)
  • Ketamine plasma levels [ Time Frame: 14 and 60 min after initiation of ketamine or placebo infusion ]
    Assessment of ketamine plasma levels
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Touchscreen-based Cognitive Tests in Healthy Volunteers
Official Title  ICMJE Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Cognitive Symptom
  • Schizophrenia
Intervention  ICMJE
  • Drug: Ketamine 0.58
    Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
    Other Name: Ketalar
  • Drug: Ketamine 0.31
    Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
    Other Name: Ketalar
  • Drug: Modafinil
    Modafinil tablet 100 mg placed in a capsule
    Other Name: Modafinil Orion
  • Drug: Placebo for ketamine
    0.9 % NaCl infusion solution
    Other Name: Placebo
  • Drug: Placebo for modafinil
    Placebo capsule for modafinil capsule
    Other Name: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo/placebo
    Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
    Interventions:
    • Drug: Placebo for ketamine
    • Drug: Placebo for modafinil
  • Experimental: Ketamine 0.58/placebo
    Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
    Interventions:
    • Drug: Ketamine 0.58
    • Drug: Placebo for modafinil
  • Experimental: Ketamine 0.58/modafinil
    Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
    Interventions:
    • Drug: Ketamine 0.58
    • Drug: Modafinil
  • Experimental: Ketamine 0.31/placebo
    Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
    Interventions:
    • Drug: Ketamine 0.31
    • Drug: Placebo for modafinil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 12, 2018)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date May 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03469089
Other Study ID Numbers  ICMJE REVISE28347
2017-004455-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party University of Eastern Finland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Eastern Finland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Markus M Forsberg, PhD University of Eastern Finland
PRS Account University of Eastern Finland
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP