Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder
• Intervention / Treatment: Other: electroconvulsive therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Ute Kessler, PhD; Email: ute.kessler@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Ute Kessler, PhD; Email: ute.kessler@helse-bergen.no
    • Principal Investigator: Ute Kessler, PhD
  • Stavanger, Norway
    • Recruiting
    • Stavanger University Hospital
    • Contact: Pernille Hegre Sørensen; Email: pernille.hegre.sorensen@sus.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

population based cohort from ordinary clinical activity

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	overall cognitive function	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	depressive symptoms, patient rated	up to 8 weeks
Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairment	overall subjective cognitive function, patient rated	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Patient rated improvement (PGI) score from pretreatment at posttreatment	Likert scale	up to 8 weeks
Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment	Likert scale	up to 8 weeks
Change of Subjective cognitive function score from pretreatment at posttreatment	Likert scale	up to 8 weeks
Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up	overall subjective cognitive function, patient rated	6 months
Change of Patient rated improvement (PGI) score from pretreatment at follow up	Likert scale	6 months
Change of Clinical Global Impression scale (CGI) from pretreatment at follow up	Likert scale	6 months
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	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	overall cognitive function	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	depressive symptoms, patient rated	6 months

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: 2018/2541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: after approval from data protection manager IPD will be shared on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No