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Depressive DisorderNCT05388461

Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

An observational study of Depressive Disorder, run by Haukeland University Hospital at 2 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Disorder
What is being tested?
electroconvulsive therapy
How many people
600 participants
Where
2 sitesNorway
Study dates
13 Mar 2013to Dec 2028
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: population based cohort from ordinary clinical activity

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ute Kessler, PhD contact

ute.kessler@helse-bergen.no

Norway2 sites, 2 recruiting

  • Haukeland University Hospital

    Bergen, 5021

    Ute Kessler, PhD, ute.kessler@helse-bergen.no

    Ute Kessler, PhD

    Recruiting

  • Stavanger University Hospital

    Stavanger

    Pernille Hegre Sørensen, pernille.hegre.sorensen@sus.no

    Recruiting

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
electroconvulsive therapy
Medical subject headings
Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electroconvulsive therapyOther

    electroconvulsive therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    depressive symptoms

    Measured: up to 8 weeks

  2. 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

    overall cognitive function

    Measured: up to 8 weeks

  3. Change of Beck depression inventory (BDI) score from pretreatment at posttreatment; BDI range 0-63, with higher scores indicating more severe depression

    depressive symptoms, patient rated

    Measured: up to 8 weeks

  4. Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairment

    overall subjective cognitive function, patient rated

    Measured: up to 8 weeks

Secondary outcomes (9)

  1. Change of Patient rated improvement (PGI) score from pretreatment at posttreatment

    Likert scale

    Measured: up to 8 weeks

  2. Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment

    Likert scale

    Measured: up to 8 weeks

  3. Change of Subjective cognitive function score from pretreatment at posttreatment

    Likert scale

    Measured: up to 8 weeks

  4. 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)

    depressive symptoms

    Measured: 6 months

  5. 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

    overall cognitive function

    Measured: 6 months

  6. Change of Beck depression inventory (BDI) score from pretreatment at follow up, BDI range 0-63, with higher scores indicating more severe depression

    depressive symptoms, patient rated

    Measured: 6 months

  7. Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up

    overall subjective cognitive function, patient rated

    Measured: 6 months

  8. Change of Patient rated improvement (PGI) score from pretreatment at follow up

    Likert scale

    Measured: 6 months

  9. Change of Clinical Global Impression scale (CGI) from pretreatment at follow up

    Likert scale

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start13 Mar 2013
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388461
Sponsor's protocol ID
2018/2541
Status last verified
Sep 2023
First submitted
13 May 2022
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: after approval from data protection manager IPD will be shared on reasonable request

Questions about this trial

What is this clinical trial studying?

An observational study of Depressive Disorder, run by Haukeland University Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ute Kessler, PhD (ute.kessler@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05388461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.

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