UnknownPhase 1ketamine

Touchscreen-based Cognitive Tests in Healthy Volunteers

Sponsored by University of Eastern Finland

NCT ID
NCT03469089
Target Enrollment
16 participants
Start Date
2018-03-12
Est. Completion
2019-12-31

About This Study

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.

Conditions Studied

Cognitive SymptomSchizophrenia

Interventions

  • Ketamine 0.58
  • Ketamine 0.31
  • Modafinil
  • Placebo for ketamine
  • Placebo for modafinil

Eligibility

Sex:MALE
Age:20 Years - 40 Years
Healthy Volunteers:Yes
View full 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

Study Locations (1)

University of Eastern Finland, Clinical Research Centre, Brain Research Unit
Kuopio, Finland

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source