Touchscreen-based Cognitive Tests in Healthy Volunteers

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03469089
• Other study ID #: REVISE28347
• Secondary ID: 2017-004455-22
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 12, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 31, 2019
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Symptom
• Neurobehavioral Manifestations
• Schizophrenia

Intervention

Drug:
• Ketamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
• Ketamine 0.31
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
• Modafinil
Modafinil tablet 100 mg placed in a capsule
• Placebo for ketamine
0.9 % NaCl infusion solution
• Placebo for modafinil
Placebo capsule for modafinil capsule

Locations

Country	Name	City	State
Finland	University of Eastern Finland, Clinical Research Centre, Brain Research Unit	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ketamine plasma levels	Assessment of ketamine plasma levels	14 and 60 min after initiation of ketamine or placebo infusion
Other	Brain-derived neurotrophic factor serum levels	Assessment of Brain-derived neurotrophic factor serum levels	14 and 60 min after initiation of ketamine of placebo infusion
Primary	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	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