Trial Outcomes & Findings for A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder (NCT NCT01957410)
NCT ID: NCT01957410
Last Updated: 2017-01-27
Results Overview
SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 64-channel EEG system at baseline (predose) and regularly after study drug administration. The change from baseline was calculated as post-baseline value minus baseline value for each participant. Since the number of participants at baseline differ from the number of participants at post-baseline measure (that is \[i.e.\] not all baseline values are paired), the mean change is not equal to the difference between the means at the two time points.
TERMINATED
PHASE2
13 participants
Baseline and Day 1 (4 hours postdose)
2017-01-27
Participant Flow
A total of 13 participants were enrolled, treated and completed the study.
Participant milestones
| Measure |
Ketamine IV 0.5mg/kg
Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
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|---|---|
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Open Label
STARTED
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13
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Open Label
COMPLETED
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13
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Open Label
NOT COMPLETED
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0
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Optional Open Label
STARTED
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13
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Optional Open Label
COMPLETED
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13
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Optional Open Label
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Ketamine IV 0.5mg/kg
n=13 Participants
Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
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Age, Continuous
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40.9 years
STANDARD_DEVIATION 11.45 • n=5 Participants
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Gender
Female
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9 Participants
n=5 Participants
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Gender
Male
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4 Participants
n=5 Participants
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Region of Enrollment
USA
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13 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and Day 1 (4 hours postdose)Population: Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of SEP (P40).
SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 64-channel EEG system at baseline (predose) and regularly after study drug administration. The change from baseline was calculated as post-baseline value minus baseline value for each participant. Since the number of participants at baseline differ from the number of participants at post-baseline measure (that is \[i.e.\] not all baseline values are paired), the mean change is not equal to the difference between the means at the two time points.
Outcome measures
| Measure |
Ketamine IV 0.5mg/kg
n=13 Participants
Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
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|---|---|
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1
Responders: Baseline (n=9)
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1.83 millivolts (mV)
Standard Deviation 1.13
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1
Responders: Day 1, 4 Hours (n=6)
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2.58 millivolts (mV)
Standard Deviation 1.24
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1
Responders: Change from Baseline (n=6)
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0.47 millivolts (mV)
Standard Deviation 1.68
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1
Non-Responders: Baseline (n=4)
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1.70 millivolts (mV)
Standard Deviation 1.10
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1
Non-Responders: Day 1, 4 Hours (n=3)
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1.84 millivolts (mV)
Standard Deviation 1.48
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1
Non-Responders: Change from Baseline (n=3)
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0.47 millivolts (mV)
Standard Deviation 0.43
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PRIMARY outcome
Timeframe: Baseline and Day 1 (4 hours postdose)Population: Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of MEP.
MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation \[TMS\]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles. The Motor Evoked Response to Transcranial Magnetic Stimulation (TMS MEPs) was evaluated at baseline and regularly after study drug administration. Intracortical inhibition and facilitation was also evaluated using TMS. A figure-of-eight coil with external loop diameters of 9 cm was used to elicit motor responses in the contralateral first dorsal interosseus.
Outcome measures
| Measure |
Ketamine IV 0.5mg/kg
n=13 Participants
Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
|
|---|---|
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1
Responders: Baseline (n=9)
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0.874 mV
Standard Deviation 0.710
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1
Responders: Day 1, 4 hour (H) (n=9)
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1.052 mV
Standard Deviation 0.867
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1
Responders: Change from Baseline (n=9)
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0.179 mV
Standard Deviation 0.765
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1
Non-Responders: Baseline (n=4)
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1.257 mV
Standard Deviation 1.055
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1
Non-Responders: Day 1, 4H (n=4)
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1.197 mV
Standard Deviation 1.067
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Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1
Non-Responders: Change from Baseline (n=4)
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-0.060 mV
Standard Deviation 0.088
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Adverse Events
Ketamine IV 0.5mg/kg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine IV 0.5mg/kg
n=13 participants at risk
Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
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Gastrointestinal disorders
Nausea
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7.7%
1/13 • Number of events 1 • Up to 1 week after the last dose administration (6 weeks)
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General disorders
Infusion site bruising
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15.4%
2/13 • Number of events 2 • Up to 1 week after the last dose administration (6 weeks)
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Infections and infestations
Bacterial vaginosis
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7.7%
1/13 • Number of events 1 • Up to 1 week after the last dose administration (6 weeks)
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Infections and infestations
Oral herpes
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7.7%
1/13 • Number of events 1 • Up to 1 week after the last dose administration (6 weeks)
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Infections and infestations
Respiratory tract infection
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7.7%
1/13 • Number of events 1 • Up to 1 week after the last dose administration (6 weeks)
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Infections and infestations
Urinary tract infection
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7.7%
1/13 • Number of events 2 • Up to 1 week after the last dose administration (6 weeks)
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Musculoskeletal and connective tissue disorders
Myalgia
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7.7%
1/13 • Number of events 1 • Up to 1 week after the last dose administration (6 weeks)
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Nervous system disorders
Headache
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30.8%
4/13 • Number of events 4 • Up to 1 week after the last dose administration (6 weeks)
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Psychiatric disorders
Panic attack
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15.4%
2/13 • Number of events 3 • Up to 1 week after the last dose administration (6 weeks)
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Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
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7.7%
1/13 • Number of events 1 • Up to 1 week after the last dose administration (6 weeks)
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Skin and subcutaneous tissue disorders
Dermatitis contact
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7.7%
1/13 • Number of events 1 • Up to 1 week after the last dose administration (6 weeks)
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Skin and subcutaneous tissue disorders
Rash
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7.7%
1/13 • Number of events 1 • Up to 1 week after the last dose administration (6 weeks)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER