NCT04657575

Brief Summary

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (\>15sec), the sympathic response and the postictal EEG-suppression. \- Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation. The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

November 3, 2023

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

November 23, 2020

Last Update Submit

November 2, 2023

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Convulsion Quality

    Adequate seizure quality was defined as \> 20 seconds motor response on the right forearm, \>25 seconds EEG seizure activity, postictal suppression index \> 80%, maximum sustained coherence \> 90% and 5.midictal amplitude \> 180µV

    One hour

Study Arms (2)

ASTI

NO INTERVENTION

ECT guided with ASTi 2-4 min

Narcotrend

ACTIVE COMPARATOR

ECT guided with ECT

Procedure: Narcotrend

Interventions

NarcotrendPROCEDURE

ECT stimulation within an anaesthesia depth range of 41-64

Narcotrend

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-3
  • Age: 18 -90 years
  • Signed informed consent
  • Severe depressive disorder

You may not qualify if:

  • ASA \>3
  • Age \< 18 or \> 90
  • denial of the patient
  • Impossibility to fix Narcotrend electrodes
  • Patients unable to consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Hospital Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 8, 2020

Study Start

March 1, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

November 3, 2023

Record last verified: 2022-04

Locations

AU(1)