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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004455-22 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/placebo | Placebo Comparator | Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule) |
|
| Ketamine 0.58/placebo | Experimental | Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil |
|
| Ketamine 0.58/modafinil | Experimental | Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg) |
|
| Ketamine 0.31/placebo | Experimental | Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine 0.58 | Drug | Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h) |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ketamine plasma levels | Assessment of ketamine plasma levels | 14 and 60 min after initiation of ketamine or placebo infusion |
| Brain-derived neurotrophic factor serum levels | Assessment of Brain-derived neurotrophic factor serum levels |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus M Forsberg, PhD | University of Eastern Finland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Eastern Finland, Clinical Research Centre, Brain Research Unit | Kuopio | 70210 | Finland |
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| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals
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Double blinded
| Ketamine 0.31 | Drug | Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h) |
|
|
| Modafinil | Drug | Modafinil tablet 100 mg placed in a capsule |
|
|
| Placebo for ketamine | Drug | 0.9 % NaCl infusion solution |
|
|
| Placebo for modafinil | Drug | Placebo capsule for modafinil capsule |
|
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| 14 and 60 min after initiation of ketamine of placebo infusion |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |