Retrograde AmnesiaNCT04516863
A Validation Study of the German Autobiographical Memory Interview
A study testing German Autobiographical Memory Interview short-form in people with Retrograde Amnesia, run by Rheinhessen-Fachklinik Alzey at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Retrograde Amnesia
- What is being tested?
- German Autobiographical Memory Interview short-form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MDD
- HDRS > 17
- Age 18-80
- Ability to give informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Rheinhessen-Fachklinik Alzey
Alzey, Rhineland-Palatinate, 55232
Sarah Kayser, MD, +49 6731 50 1278, s.kayser@rfk.landeskrankenhaus.de
About this study
Official title: Validation of the German Short Version of the Autobiographical Memory Interview in Patients With Depression and Healthy Controls
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.
Read the 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.
- Conditions
- Retrograde Amnesia
- Being tested
- German Autobiographical Memory Interview short-form
- Keywords
- Electroconvulsive therapy, Depression, Cognitive side effects
- Medical subject headings
- Amnesia, Retrograde, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
German Autobiographical Memory Interview short-formDiagnostic test
Also called D-AMI
Diagnostic Test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: German Autobiographical Memory Interview short-form |
| Healthy controls | Active comparator | - Mental health Receives: Diagnostic Test: German Autobiographical Memory Interview short-form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-post (six weeks)
Secondary outcomes (4)
Hamilton Depression Rating Scale (HAMD-17)
Change in depression severity
Measured: pre-post (six weeks)
Inventar Depressiver Symptome (IDS)
Change in depression severity
Measured: pre-post (six weeks)
36-item Health Survey (SF-36)
Change in qualtiy of life
Measured: pre-post (six weeks)
Global Self-Evaluation-Memory (GSE-My)
Change in self-evaluation of memory
Measured: pre-post (six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start15 Aug 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrograde AmnesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rheinhessen-Fachklinik Alzey
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Responsible party
- Principal investigator, Sarah Kayser, Rheinhessen-Fachklinik Alzey
- Investigators
- Sarah PD Dr. med. MSc. Kayser, MD, Principal investigator, Rheinhessen-Fachklinik Alzey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516863
- Sponsor's protocol ID
- D-AMI 1.1
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the German Short Version of the Autobiographical Memory Interview in Patients With Depression and Healthy Controls
- ClinicalTrials.gov ID
- NCT04516863
- Acronym / sponsor ID
- D-AMI 1.1
- Conditions
- Retrograde Amnesia
- Keywords
- Electroconvulsive therapy, Depression, Cognitive side effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rheinhessen-Fachklinik AlzeyUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with depression | Active comparator | Diagnostic Test: German Autobiographical Memory Interview short-form* 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 |
| Healthy controls | Active comparator | Diagnostic Test: German Autobiographical Memory Interview short-form- Mental health |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MDD
- HDRS > 17
- Age 18-80
- Ability to give informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| German Autobiographical Memory Interview short-formAlso: D-AMIDiagnostic Test | Diagnostic test | Healthy controls, Patients with depression |
Primary outcome
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.
4 secondary outcomes
Hamilton Depression Rating Scale (HAMD-17)
Time frame: pre-post (six weeks)
Inventar Depressiver Symptome (IDS)
Time frame: pre-post (six weeks)
36-item Health Survey (SF-36)
Time frame: pre-post (six weeks)
Global Self-Evaluation-Memory (GSE-My)
Time frame: pre-post (six weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah PD Dr. med. MSc. Kayser, MD principal investigator
Rheinhessen-Fachklinik Alzey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing German Autobiographical Memory Interview short-form in people with Retrograde Amnesia, run by Rheinhessen-Fachklinik Alzey at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah PD Dr. med. MSc. Kayser, MD (+ 49 6731 50 1278, s.kayser@rfk.landeskrankenhaus.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
German Autobiographical Memory Interview short-form (time frame: pre-post (six weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020; AzTrials last refreshed its copy on 27 Oct 2026.