A Validation Study of the German Autobiographical Memory... | NCT04516863

Studies
A Validation Study of the German Autobiographical Memory Interview

NCT04516863

Sponsor

Rheinhessen-Fachklinik Alzey

Status

Unknown status

Last Update Posted

Aug 18, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Retrograde Amnesia

Interventions

German Autobiographical Memory Interview short-form

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2020Actual

Primary Completion Date

May 1, 2021Estimated

Completion Date

May 1, 2021Estimated

First Submitted Date

Aug 11, 2020

First Submission Date that Met QC Criteria

Aug 17, 2020

First Posted Date

Aug 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2020

Last Update Posted Date

Aug 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sarah Kayser, PD Dr. med. Sarah Kayser, MSc., Rheinhessen-Fachklinik AlzeyPrincipal Investigator

Lead Sponsor

Rheinhessen-Fachklinik AlzeyOTHER

Collaborators

Name	Class
Johannes Gutenberg University Mainz	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
German Autobiographical Memory Interview short-form	Diagnostic Test	Diagnostic Test	Healthy controls Patients with depression

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Hamilton Depression Rating Scale (HAMD-17)	Change in depression severity	pre-post (six weeks)
Inventar Depressiver Symptome (IDS)	Change in depression severity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah PD Dr. med. MSc. Kayser, MD	Contact	+ 49 6731 50 1278		s.kayser@rfk.landeskrankenhaus.de

Overall Officials

Name	Affiliation	Role
Sarah PD Dr. med. MSc. Kayser, MD	Rheinhessen-Fachklinik Alzey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rheinhessen-Fachklinik Alzey	Recruiting	Alzey	Rhineland-Palatinate	55232	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000648	Amnesia, Retrograde
D003863	Depression

Ancestor Terms

ID	Term
D000647	Amnesia
D008569	Memory Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

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Browse Branches

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