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Recruiting NCT05388461

Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

— Observational Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: electroconvulsive therapy.
Who it may be relevant to
Registry conditions: Depressive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy for Severe or Treatment Resistant Depression - Predictors of Response, Side Effects, and Relapse

Overview

The overall aim of the current project is to assess the acute and long term outcome of ECT (both patient and clinician rated) in a non-selected patient cohort from ordinary clinical activity, and to seek out factors predicting response and remission, side effects and relapse.

Detailed description

Patients reffered to electroconvulsive ECT are (after written consent) enroled in a research registry. Based on (clinician and patient rated) measures of depressive symptoms and overall cognitive function, the short and long-term (6 months) efficacy of ECT will be described, and factors predicting response and relapse identified.

The duration of possible cognitive impairment and factors predicting cognitive outcome will be examined.

Interventions

  • Other electroconvulsive therapy
    electroconvulsive therapy

Primary outcome measures

  • Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at posttreatment; MADRS range 0 - 60, with higher scores indicating more severe depression) [Time frame: up to 8 weeks]
  • Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at posttreatment; MMS-E range 0-30 with lower scores indicating more severe cognitive impairment [Time frame: up to 8 weeks]
  • Change of Beck depression inventory (BDI) score from pretreatment at posttreatment; BDI range 0-63, with higher scores indicating more severe depression [Time frame: up to 8 weeks]
  • Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairment [Time frame: up to 8 weeks]
Secondary outcome measures (9)
  • Change of Patient rated improvement (PGI) score from pretreatment at posttreatment [Time frame: up to 8 weeks]
  • Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment [Time frame: up to 8 weeks]
  • Change of Subjective cognitive function score from pretreatment at posttreatment [Time frame: up to 8 weeks]
  • Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at follow up, MADRS range 0 - 60, with higher scores indicating more severe depression) [Time frame: 6 months]
  • Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at follow up, MMS-E range 0-30 with lower scores indicating more severe cognitive impairment [Time frame: 6 months]
  • Change of Beck depression inventory (BDI) score from pretreatment at follow up, BDI range 0-63, with higher scores indicating more severe depression [Time frame: 6 months]
  • Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up [Time frame: 6 months]
  • Change of Patient rated improvement (PGI) score from pretreatment at follow up [Time frame: 6 months]
  • Change of Clinical Global Impression scale (CGI) from pretreatment at follow up [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Patients treated with ECT for major depression (F31.3-5, F32, F33) at Haukeland University Hospital or Stavanger University Hospital after 2013,
  • written consent to enrolment into the Regional Register for neurostimulation.

Exclusion criteria

  • ECT performed on other indications than major depression.
  • No consent to the register.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Norway · 2 centers
  • Haukeland University Hospital — Bergen
  • Stavanger University Hospital — Stavanger

Identifiers

NCT: NCT05388461 · 2018/2541

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗