Touchscreen-based Cognitive Tests in Healthy Volunteers

University of Eastern Finland

Status and phase: Unknown; Phase 1

Conditions: Schizophrenia; Cognitive Symptom

Treatments: Drug: Placebo for modafinil; Drug: Ketamine 0.31; Drug: Ketamine 0.58; Drug: Modafinil; Drug: Placebo for ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03469089

2017-004455-22 (EudraCT Number)

REVISE28347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 4 patient groups, including a placebo group

Placebo/placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for ketamine

Drug: Placebo for modafinil

Ketamine 0.58/placebo

Experimental group

Description:

Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil

Treatment:

Drug: Ketamine 0.58

Drug: Placebo for modafinil

Ketamine 0.58/modafinil

Experimental group

Description:

Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)

Treatment:

Drug: Modafinil

Drug: Ketamine 0.58

Ketamine 0.31/placebo

Experimental group

Description:

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

Treatment:

Drug: Ketamine 0.31

Drug: Placebo for modafinil