NCT03469089|UnknownPhase 1DMC
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
16
1 country
1
Study Start
March 12, 2018
Actual (reported)Primary Completion
May 16, 2018
Actual (reported)Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2018
Actual (reported)March 12, 2018
Actual (reported)March 19, 2018
Actual (reported)May 16, 2018
Actual (reported)December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Effect of modafinil on ketamine-induced cognitive deficits
15-60 min after initiation of ketamine or placebo infusion
Ketamine plasma levels
14 and 60 min after initiation of ketamine or placebo infusion
Brain-derived neurotrophic factor serum levels
14 and 60 min after initiation of ketamine of placebo infusion
Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Placebo for ketamine
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordControl intervention
Placebo for modafinil
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordUniversity of Eastern Finland, Clinical Research Centre, Brain Research Unit
Kuopio, 70210, Finland
Markus M Forsberg, PhD
University of Eastern Finland
16 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2018
First Posted
March 19, 2018
Study Start
March 12, 2018
PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
Modafinil tablet 100 mg placed in a capsule
0.9 % NaCl infusion solution
Placebo capsule for modafinil capsule
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 16, 2018
Actual (reported)Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 16, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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