A Phase 1 interventional study of Ketamine 0.58 and Ketamine 0.31 in Cognitive Symptom and Schizophrenia, sponsored by University of Eastern Finland. Status unknown at 1 site in Finland. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by University of Eastern Finland · Phase 1, Interventional, and Basic science
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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.
130 studies on the registry are indexed under Neurobehavioral Manifestations; 27 are open to participants now.
This study's enrollment of 16 is below the median of 74 across 96 interventional studies indexed under Neurobehavioral Manifestations.
Browse Neurobehavioral Manifestations studies →University of Eastern Finland is the lead sponsor of 54 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Drug: Placebo for ketamine · Drug: Placebo for modafinil
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Drug: Ketamine 0.58 · Drug: Placebo for modafinil
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Drug: Ketamine 0.58 · Drug: Modafinil
Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
Drug: Ketamine 0.31 · Drug: Placebo for modafinil
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Also known as: Ketalar
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
Also known as: Ketalar
Modafinil tablet 100 mg placed in a capsule
Also known as: Modafinil Orion
0.9 % NaCl infusion solution
Also known as: Placebo
Placebo capsule for modafinil capsule
Also known as: Placebo
Ketamine-induced cognitive deficits
Ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
Time frame: 15-60 min after initiation of ketamine or placebo infusion
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
Time frame: 15-60 min after initiation of ketamine or placebo infusion
Ketamine plasma levels
Assessment of ketamine plasma levels
Time frame: 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
Time frame: 14 and 60 min after initiation of ketamine of placebo infusion
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in May 2018, 2 months.
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This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ketamine · Modafinil
Neurobehavioral Manifestations →
University of Eastern Finland