Depressive Disorder Clinical Trial
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
NCT number | NCT05388461 |
Other study ID # | 2018/2541 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 13, 2013 |
Est. completion date | December 2028 |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2028 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen | |
Norway | Stavanger University Hospital | Stavanger |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | Helse Stavanger HF |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change of Patient rated improvement (PGI) score from pretreatment at posttreatment | Likert scale | up to 8 weeks | |
Secondary | Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment | Likert scale | up to 8 weeks | |
Secondary | Change of Subjective cognitive function score from pretreatment at posttreatment | Likert scale | up to 8 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up | overall subjective cognitive function, patient rated | 6 months | |
Secondary | Change of Patient rated improvement (PGI) score from pretreatment at follow up | Likert scale | 6 months | |
Secondary | Change of Clinical Global Impression scale (CGI) from pretreatment at follow up | Likert scale | 6 months |
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