Clinical Trial Results:
Electroconvulsive therapy vs. esketamine nasal spray in treatment-resistant depression: a longitudinal, randomized efficacy comparison pilot study
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Summary
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EudraCT number |
2020-004172-17 |
Trial protocol |
AT |
Global end of trial date |
01 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jan 2023
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First version publication date |
29 Jan 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ETES
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medizinische Universität Innsbruck
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Sponsor organisation address |
Innrain 52, Innsbruck, Austria, 6020
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Public contact |
Kompetenzzentrum klinische Studien, Medizinische Universität Innsbruck, kks-regulatory@i-med.ac.at
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Scientific contact |
Kompetenzzentrum klinische Studien, Medizinische Universität Innsbruck, kks-regulatory@i-med.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
25 Jul 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jun 2022
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To compare the effectiveness of electroconvulsive therapy (ECT) vs. esketamine nasal spray using the Montgomery Asberg Depression Rating Scale (MADRS)
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Protection of trial subjects |
weekly assesment
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 99999999
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Worldwide total number of subjects |
99999999
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EEA total number of subjects |
99999999
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
99999999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
no patients recruited | |||||||||
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Pre-assignment
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Screening details |
no patients recruited | |||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ketamine | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Spravato
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Intranasal use
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Dosage and administration details |
56 mg (2 devices of SPRAVATO™)
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Arm title
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ECT-Arm | |||||||||
Arm description |
- | |||||||||
Arm type |
Electroconvulsive Therapy | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: we did not enroll any patients. |
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End points reporting groups
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Reporting group title |
Ketamine
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Reporting group description |
- | ||
Reporting group title |
ECT-Arm
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Reporting group description |
- | ||
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End point title |
effect of treatment (ECT vs. esketamine) on depression MADRS [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
non, because no patients recruited
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: we did not recruit any patients. Therefor we have no statistical analysis |
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| Notes [2] - no patients recruited, study suspended [3] - no patients recruited |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
n.a.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
n.a. | ||
Dictionary version |
n.a.
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: we did not recruit any patients. Therefor we have no non-serious adverse events |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
