Touchscreen-based Cognitive Tests in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers

Conditions
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Cognitive Symptom, Schizophrenia

Intervention / Treatment
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* Drug: Ketamine 0.58
* Drug: Ketamine 0.31
* Drug: Modafinil
* Drug: Placebo for ketamine
* Drug: Placebo for modafinil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo/placebo<br>Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule) | Drug: Placebo for ketamine<br>* 0.9 % NaCl infusion solution<br>* Other names: Placebo;Drug: Placebo for modafinil<br>* Placebo capsule for modafinil capsule<br>* Other names: Placebo;|
| Experimental: Ketamine 0.58/placebo<br>Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil | Drug: Ketamine 0.58<br>* Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)<br>* Other names: Ketalar;Drug: Placebo for modafinil<br>* Placebo capsule for modafinil capsule<br>* Other names: Placebo;|
| Experimental: Ketamine 0.58/modafinil<br>Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg) | Drug: Ketamine 0.58<br>* Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)<br>* Other names: Ketalar;Drug: Modafinil<br>* Modafinil tablet 100 mg placed in a capsule<br>* Other names: Modafinil Orion;|
| Experimental: Ketamine 0.31/placebo<br>Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil | Drug: Ketamine 0.31<br>* Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)<br>* Other names: Ketalar;Drug: Placebo for modafinil<br>* Placebo capsule for modafinil capsule<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ketamine-induced cognitive deficits | Ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery | 15-60 min after initiation of ketamine or placebo infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 15-60 min after initiation of ketamine or placebo infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, cognitive symptom, healthy volunteer, cognitive testing