Schizophrenia Clinical Trial
Official title:
Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers
Verified date | October 2018 |
Source | University of Eastern Finland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Finland | University of Eastern Finland, Clinical Research Centre, Brain Research Unit | Kuopio |
Lead Sponsor | Collaborator |
---|---|
University of Eastern Finland |
Finland,
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 |
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