Touchscreen-based Cognitive Tests in Healthy Volunteers

Phase 1

• Conditions: Schizophrenia; Cognitive Symptom
• Interventions: Drug: Ketamine 0.58; Drug: Placebo for ketamine; Drug: Ketamine 0.31; Drug: Modafinil; Drug: Placebo for modafinil

• Registration Number: NCT03469089
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-03-12
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Primary Completion: 2018-05-16
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketamine 0.58/placebo	Ketamine 0.58	Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Ketamine 0.58/modafinil	Ketamine 0.58	Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Ketamine 0.58/modafinil	Modafinil	Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Placebo/placebo	Placebo for ketamine	Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Ketamine 0.58/placebo	Placebo for modafinil	Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Placebo/placebo	Placebo for modafinil	Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Ketamine 0.31/placebo	Ketamine 0.31	Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
Ketamine 0.31/placebo	Placebo for modafinil	Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil

Primary Outcome Measures

Name	Time	Method
Ketamine-induced cognitive deficits	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

Name	Time	Method
Effect of modafinil on ketamine-induced cognitive deficits	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

Trial Locations

Locations (1)

University of Eastern Finland, Clinical Research Centre, Brain Research Unit; 🇫🇮 Kuopio, Finland