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Status unknownNCT03469089Updated Oct 16, 2018

Touchscreen-based Cognitive Tests in Healthy Volunteers

A Phase 1 interventional study of Ketamine 0.58 and Ketamine 0.31 in Cognitive Symptom and Schizophrenia, sponsored by University of Eastern Finland. Status unknown at 1 site in Finland. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by University of Eastern Finland · Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Cognitive Symptom
  • Schizophrenia

Keywords

  • schizophrenia
  • cognitive symptom
  • healthy volunteer
  • cognitive testing
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Placebo comparator
    Placebo/placebo

    Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)

    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

    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)

    Drug: Ketamine 0.58 · Drug: Modafinil

  • Experimental
    Ketamine 0.31/placebo

    Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil

    Drug: Ketamine 0.31 · Drug: Placebo for modafinil

Interventions

  • DrugKetamine 0.58

    Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)

    Also known as: Ketalar

  • DrugKetamine 0.31

    Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)

    Also known as: Ketalar

  • DrugModafinil

    Modafinil tablet 100 mg placed in a capsule

    Also known as: Modafinil Orion

  • DrugPlacebo for ketamine

    0.9 % NaCl infusion solution

    Also known as: Placebo

  • DrugPlacebo for modafinil

    Placebo capsule for modafinil capsule

    Also known as: Placebo

05

What researchers measure

Primary outcomes

  1. Ketamine-induced cognitive deficits

    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 outcomes

  1. 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

    Time frame: 15-60 min after initiation of ketamine or placebo infusion

Other outcomes

  1. Ketamine plasma levels

    Assessment of ketamine plasma levels

    Time frame: 14 and 60 min after initiation of ketamine or placebo infusion

  2. Brain-derived neurotrophic factor serum levels

    Assessment of Brain-derived neurotrophic factor serum levels

    Time frame: 14 and 60 min after initiation of ketamine of placebo infusion

06

Study locations

1 site
  • University of Eastern Finland, Clinical Research Centre, Brain Research Unit
    Kuopio, 70210, Finland
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03469089
Lead sponsor
University of Eastern Finland
Responsible party
Sponsor
First posted
Mar 19, 2018
Start date
Mar 12, 2018
Primary completion
May 16, 2018
Completion
Dec 31, 2019 (estimated)
Last update
Oct 16, 2018

Study contacts

Markus M Forsberg, PhD
study director · University of Eastern Finland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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