Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Validation Study of the German Autobiographical Memory Interview

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04516863
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Collaborator:
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Sarah Kayser, Rheinhessen-Fachklinik Alzey

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Retrograde Amnesia Diagnostic Test: German Autobiographical Memory Interview short-form Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of the German Short Version of the Autobiographical Memory Interview in Patients With Depression and Healthy Controls
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 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
 Diagnostic Test: German Autobiographical Memory Interview short-form
Diagnostic Test
Other Name: D-AMI
Active Comparator: Healthy controls
- Mental health
 Diagnostic Test: German Autobiographical Memory Interview short-form
Diagnostic Test
Other Name: D-AMI


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. German Autobiographical Memory Interview short-form [ Time Frame: pre-post (six weeks) ]
    Changes in autobiographical memory measured with the German Autobiographical Memory Interview short-form pre-post in depressed patients vs. a healthy control Group.


Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: pre-post (six weeks) ]
    Change in depression severity

  2. Inventar Depressiver Symptome (IDS) [ Time Frame: pre-post (six weeks) ]
    Change in depression severity

  3. 36-item Health Survey (SF-36) [ Time Frame: pre-post (six weeks) ]
    Change in qualtiy of life

  4. Global Self-Evaluation-Memory (GSE-My) [ Time Frame: pre-post (six weeks) ]
    Change in self-evaluation of memory


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516863


Contacts
Layout table for location contacts
Contact: Sarah PD Dr. med. MSc. Kayser, MD + 49 6731 50 1278 s.kayser@rfk.landeskrankenhaus.de

Locations
Layout table for location information
Germany
Rheinhessen-Fachklinik Alzey Recruiting
Alzey, Rheinland-Pfalz, Germany, 55232
Contact: Sarah Kayser, MD    +49 6731 50 1278    s.kayser@rfk.landeskrankenhaus.de   
Sponsors and Collaborators
Rheinhessen-Fachklinik Alzey
Johannes Gutenberg University Mainz
Investigators
Layout table for investigator information
Principal Investigator: Sarah PD Dr. med. MSc. Kayser, MD Rheinhessen-Fachklinik Alzey
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sarah Kayser, PD Dr. med. Sarah Kayser, MSc., Rheinhessen-Fachklinik Alzey
ClinicalTrials.gov Identifier: NCT04516863    
Other Study ID Numbers: D-AMI 1.1
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Kayser, Rheinhessen-Fachklinik Alzey:
Electroconvulsive therapy
Depression
Cognitive side effects
Additional relevant MeSH terms:
Layout table for MeSH terms
Amnesia
Amnesia, Retrograde
Memory Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders