Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy

NCT05388461 | Recruiting

• 1 other identifier: 2018/2541
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

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

  up to 8 weeks

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

  up to 8 weeks

• Change of Subjective cognitive function score from pretreatment at posttreatment

  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)

  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

  6 months

Interventions

electroconvulsive therapy OTHER

electroconvulsive therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

population based cohort from ordinary clinical activity

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Stavanger HF: collaborator

Study Sites (2)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Ute Kessler, PhD

CONTACT

ute.kessler@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 24, 2022
• Study Start: March 13, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

NO (2)