Cognitive Symptom, Schizophrenia
Conditions
Keywords
schizophrenia, cognitive symptom, healthy volunteer, cognitive testing
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.
Detailed 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.
Interventions
DRUGKetamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
DRUGKetamine 0.31
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
DRUGModafinil
Modafinil tablet 100 mg placed in a capsule
DRUGPlacebo for ketamine
0.9 % NaCl infusion solution
DRUGPlacebo for modafinil
Placebo capsule for modafinil capsule
Sponsors
University of Eastern Finland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded
Intervention model description
All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ketamine-induced cognitive deficits | 15-60 min after initiation of ketamine or placebo infusion | Ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of modafinil on ketamine-induced cognitive deficits | 15-60 min after initiation of ketamine or placebo infusion | The effect of modafinil on ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ketamine plasma levels | 14 and 60 min after initiation of ketamine or placebo infusion | Assessment of ketamine plasma levels |
| Brain-derived neurotrophic factor serum levels | 14 and 60 min after initiation of ketamine of placebo infusion | Assessment of Brain-derived neurotrophic factor serum levels |
Countries
Finland
Outcome results
None listed