Touchscreen-based Cognitive Tests in Healthy Volunteers

NCT03469089 | Unknown Phase 1 DMC

• 2 other identifiers: REVISE283472017-004455-22
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Symptom; Schizophrenia

Keywords

schizophrenia; cognitive symptom; healthy volunteer; cognitive testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of modafinil on ketamine-induced cognitive deficits

  15-60 min after initiation of ketamine or placebo infusion

Other Outcomes (2)

• Ketamine plasma levels

  14 and 60 min after initiation of ketamine or placebo infusion

• Brain-derived neurotrophic factor serum levels

  14 and 60 min after initiation of ketamine of placebo infusion

Study Arms (4)

Placebo/placebo

PLACEBO COMPARATOR

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

Drug: Placebo for ketamine; Drug: Placebo for modafinil

Ketamine 0.58/placebo

EXPERIMENTAL

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

Drug: Ketamine 0.58; Drug: Placebo for modafinil

Ketamine 0.58/modafinil

EXPERIMENTAL

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

Drug: Ketamine 0.58; Drug: Modafinil

Ketamine 0.31/placebo

EXPERIMENTAL

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

Drug: Ketamine 0.31; Drug: Placebo for modafinil

Interventions

Ketamine 0.58 DRUG

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

Also known as: Ketalar

Ketamine 0.58/modafinil; Ketamine 0.58/placebo

Ketamine 0.31 DRUG

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

Also known as: Ketalar

Ketamine 0.31/placebo

Modafinil DRUG

Modafinil tablet 100 mg placed in a capsule

Also known as: Modafinil Orion

Ketamine 0.58/modafinil

Placebo for ketamine DRUG

0.9 % NaCl infusion solution

Also known as: Placebo

Placebo/placebo

Placebo for modafinil DRUG

Placebo capsule for modafinil capsule

Also known as: Placebo

Ketamine 0.31/placebo; Ketamine 0.58/placebo; Placebo/placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Eastern Finland: lead

Study Sites (1)

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

Kuopio, 70210, Finland

Location

MeSH Terms

Conditions

Neurobehavioral Manifestations; Schizophrenia

Interventions

Ketamine; Modafinil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Markus M Forsberg, PhD

  University of Eastern Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: March 12, 2018
• Primary Completion: May 16, 2018
• Study Completion: December 31, 2019
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

FI (1)