NCT04516863

Brief Summary

Electroconvulsive therapy (ECT) is recommended for the treatment of severe depression. But, despite the high remission rates the use of ECT is strongly limited by the social stigma and treatment-emergent cognitive side effects in patients. The most relevant is retrograde amnesia (RA), because it can persists for months and years. To measure RA after ECT the short-form of the Autobiographical Memory Interview (SF-AMI) is commonly used. However, the validation of the German SF-AMI has not yet been carried out. Thus, the aim of this study is to validate the German SF-AMI in depressed patient and healthy controls. The investigators hypothesize that the German SF-AMI is reliable and valid to quantify RA.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

9 months

First QC Date

August 11, 2020

Last Update Submit

August 17, 2020

Conditions

Retrograde Amnesia

Keywords

Electroconvulsive therapyDepressionCognitive side effects

Outcome Measures

Primary Outcomes (1)

  • German Autobiographical Memory Interview short-form

    Changes in autobiographical memory measured with the German Autobiographical Memory Interview short-form pre-post in depressed patients vs. a healthy control Group.

    pre-post (six weeks)

Secondary Outcomes (4)

  • Hamilton Depression Rating Scale (HAMD-17)

    pre-post (six weeks)

  • Inventar Depressiver Symptome (IDS)

    pre-post (six weeks)

  • 36-item Health Survey (SF-36)

    pre-post (six weeks)

  • Global Self-Evaluation-Memory (GSE-My)

    pre-post (six weeks)

Study Arms (2)

Patients with depression

ACTIVE COMPARATOR

* Major depression according to DSM-V and ICD-10 (ICD F32.1, F32.2, F32.3, F33.1, F33.2, F33.3) * Hamilton Depression Rating Scale \> 17

Diagnostic Test: German Autobiographical Memory Interview short-form

Healthy controls

ACTIVE COMPARATOR

\- Mental health

Diagnostic Test: German Autobiographical Memory Interview short-form

Interventions

German Autobiographical Memory Interview short-formDIAGNOSTIC_TEST

Diagnostic Test

Also known as: D-AMI
Healthy controlsPatients with depression

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MDD
  • HDRS \> 17
  • Age 18-80
  • Ability to give informed consent

You may not qualify if:

  • Drugs or drug abuse or addictions
  • Use of benzodiazepine equivalent to lorazepam\> 1.5 mg per day
  • Cognitive impairments
  • History of traumatic brain injury
  • Relevant organic disease, e.g. Multiple sclerosis, Parkinson's disease
  • Bipolar illness, dementia or schizophrenic disorder
  • German is not the mother tongue
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheinhessen-Fachklinik Alzey

Alzey, Rhineland-Palatinate, 55232, Germany

RECRUITING

MeSH Terms

Conditions

Amnesia, RetrogradeDepression

Condition Hierarchy (Ancestors)

AmnesiaMemory DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Sarah PD Dr. med. MSc. Kayser, MD

    Rheinhessen-Fachklinik Alzey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah PD Dr. med. MSc. Kayser, MD

CONTACT

+ 49 6731 50 1278s.kayser@rfk.landeskrankenhaus.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. Sarah Kayser, MSc.

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 18, 2020

Study Start

August 15, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)