A Validation Study of the German Autobiographical Memory Interview

NCT ID: NCT04516863

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retrograde Amnesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with depression

* 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

Group Type ACTIVE_COMPARATOR

German Autobiographical Memory Interview short-form

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test

Healthy controls

\- Mental health

Group Type ACTIVE_COMPARATOR

German Autobiographical Memory Interview short-form

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

German Autobiographical Memory Interview short-form

Diagnostic Test

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

D-AMI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johannes Gutenberg University Mainz

OTHER

Sponsor Role collaborator

Rheinhessen-Fachklinik Alzey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sarah Kayser

PD Dr. med. Sarah Kayser, MSc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah PD Dr. med. MSc. Kayser, MD

Role: PRINCIPAL_INVESTIGATOR

Rheinhessen-Fachklinik Alzey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rheinhessen-Fachklinik Alzey

Alzey, Rhineland-Palatinate, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah PD Dr. med. MSc. Kayser, MD

Role: CONTACT

+ 49 6731 50 1278

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sarah Kayser, MD

Role: primary

+49 6731 50 1278

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D-AMI 1.1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Memory Flexibility Training for Depression
NCT02371291 COMPLETED PHASE1/PHASE2