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NCT Number: NCT05388461

Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

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.

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroconvulsive therapy

Other

electroconvulsive therapy

Primary outcomes

  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)

    Time frame: up to 8 weeks

    depressive symptoms

  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

    Time frame: up to 8 weeks

    overall cognitive function

  3. 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

    depressive symptoms, patient rated

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

    Time frame: up to 8 weeks

    overall subjective cognitive function, patient rated

Secondary outcomes

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

    Time frame: up to 8 weeks

    Likert scale

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

    Time frame: up to 8 weeks

    Likert scale

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

    Time frame: up to 8 weeks

    Likert scale

  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)

    Time frame: 6 months

    depressive symptoms

  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

    Time frame: 6 months

    overall cognitive function

  6. 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

    depressive symptoms, patient rated

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

    Time frame: 6 months

    overall subjective cognitive function, patient rated

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

    Time frame: 6 months

    Likert scale

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

    Time frame: 6 months

    Likert scale

Study contacts

Contact information is provided by the study sponsor or research team.

Ute Kessler, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Stavanger HF

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2028
Study completion
2028
First posted
May 24, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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