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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05388461
Enrollment
600
Registered
2022-05-24
Start date
2013-03-13
Completion date
2028-12-31
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

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.

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

OTHERelectroconvulsive therapy

electroconvulsive therapy

Sponsors

Helse Stavanger HF
CollaboratorOTHER_GOV
Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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)up to 8 weeksdepressive symptoms
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 impairmentup to 8 weeksoverall cognitive function
Change of Beck depression inventory (BDI) score from pretreatment at posttreatment; BDI range 0-63, with higher scores indicating more severe depressionup to 8 weeksdepressive symptoms, patient rated
Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairmentup to 8 weeksoverall subjective cognitive function, patient rated

Secondary

MeasureTime frameDescription
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 impairment6 monthsoverall cognitive function
Change of Beck depression inventory (BDI) score from pretreatment at follow up, BDI range 0-63, with higher scores indicating more severe depression6 monthsdepressive symptoms, patient rated
Change of Patient rated improvement (PGI) score from pretreatment at posttreatmentup to 8 weeksLikert scale
Change of Patient rated improvement (PGI) score from pretreatment at follow up6 monthsLikert scale
Change of Clinical Global Impression scale (CGI) from pretreatment at follow up6 monthsLikert scale
Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up6 monthsoverall subjective cognitive function, patient rated
Change of Clinical Global Impression (CGI) score from pretreatment at posttreatmentup to 8 weeksLikert scale
Change of Subjective cognitive function score from pretreatment at posttreatmentup to 8 weeksLikert scale
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 monthsdepressive symptoms

Countries

Norway

Contacts

Primary ContactUte Kessler, PhD
ute.kessler@helse-bergen.no

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026