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A Validation Study of the German Autobiographical Memory Interview

R

Rheinhessen-Fachklinik Alzey

Status

Unknown

Conditions

Retrograde Amnesia

Treatments

Diagnostic Test: German Autobiographical Memory Interview short-form

Study type

Interventional

Funder types

Other

Identifiers

NCT04516863
D-AMI 1.1

Details and patient eligibility

About

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.

Full description

To measure retrograde amnesia of autobiographical memory after ECT, various tests were used so far. Currently, the short form of the Autobiographical Memory Interview (AMI-SF) was used most frequently internationally. In Germany there is no validated translation of the AMI-SF. However, in order to be able to systematically record the cognitive side effects of ECT in clinical practice as well as in research in the German-speaking area, it is important to have validated test procedures that can be successfully used in repeated measurements. In this study, the German version of the AMI (D-AMI), i.e. the specificity of the German short version of the autobiographical memory in patients with depression will be investigated. It is also known in healthy people that autobiographical memory contents can no longer be called up over time. Therefore, the aim of this study is to investigate whether a change in autobiographical memory over the course of time in depressed patients differs from healthy control subjects. It should also be shown whether this German short version for examining autobiographical memory (D-AMI) can be carried out.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Patients with depression
Active Comparator group
Description:
* 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
Treatment:
Diagnostic Test: German Autobiographical Memory Interview short-form
Healthy controls
Active Comparator group
Description:
- Mental health
Treatment:
Diagnostic Test: German Autobiographical Memory Interview short-form

Trial contacts and locations

1

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Central trial contact

Sarah PD Dr. med. MSc. Kayser, MD

Data sourced from clinicaltrials.gov

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