MAjor Depressive DisorderNCT03009448
The Experience of Older Adults Facing Depression for the First Time in Old Age
An observational study of MAjor Depressive Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
Analysis of recent studies show that researchers find it hard to distinguish between Late Onset Depression, a first diagnosed major depressive episode which occurs at old age, and Early Onset Depression, a depressive episode at old age with a history of previous episodes. Read more about this study
- Who is it for?
- Ages 62 years and older
- Conditions the study is for
- MAjor Depressive Disorder
- What is being tested?
- Interview
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2017to Oct 2017
- Phase
- Observational
- 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 62 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Israeli men and women after the age of retirement, 67 and 62 respectably, who are diagnosed with a major depressive episode, minor depressive episode or show depressive symptoms for the first time in their lives at old age.
Who may be able to join
- Men aged 67 or more, women aged 62 or more
- Diagnosis of Major Depressive Disorder, Minor Depressive Disorder or Adjustment Disorder with depressive features made after the age of 67 with men and 62 with women.
- Basic understanding and ability to converse in Hebrew.
Who cannot join
- History of at least one previous major depressive or minor depressive episode before the age of 62 with women or 67 with men
- Mental Retardation or Autistic Spectrum Disorder
- Significant cognitive impairment observed by the primary physician.
- Schizophrenia or Schizoaffective disorder.
- Depressive episode with psychotic features
- Substantial suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Analysis of recent studies show that researchers find it hard to distinguish between Late Onset Depression, a first diagnosed major depressive episode which occurs at old age, and Early Onset Depression, a depressive episode at old age with a history of previous episodes. Since current data, about the phenomenology and etiology of Late Onset Depression, lake conicity it is unclear whether this phenomena should be considered as a distinct subtype of depression. Nevertheless, the wide spread assumption is that Late Onset Depression has a stronger correlation with brain damage and environmental risk factors such as the common losses at old age and weaker correlation with family history and genetics when compared to Early Onset. Although many researchers consider brain damage to have the main contribution to the emerge of Late Onset Depression, the fact that depression has a negative effect on one's health supports the claim that it might be the result and not the rick factor. Since Late Onset Depression correlates with the common losses at old age, the investigators propose that an existential approach that deals with one's meaning, freedom, responsibly and death, might be more appropriate. Thus, the investigators ask how do older adults experience depression which they face for the first time in old age? Current study will seek to understand older adults' experience of Late Onset depression through existential paradigm by using a semi constructed interview.
- Conditions
- MAjor Depressive Disorder
- Being tested
- Interview
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Each subject will be interviewed using a semi constructed interview.
| Study group | Role | What they receive |
|---|---|---|
| Late onset depression | Not described Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data analysis
All the data collected, from each semi structured interview, will be analyzed by the investigator to find similarities or differences between the older adults' experience and to identify specific existential themes.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startMar 2017
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAjor Depressive DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009448
- Sponsor's protocol ID
- shalvataMHC
- Status last verified
- Dec 2016
- First submitted
- 23 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience of Older Adults Facing Depression for the First Time in Old Age
- ClinicalTrials.gov ID
- NCT03009448
- Acronym / sponsor ID
- shalvataMHC
- Conditions
- MAjor Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Mar 2017
- Primary completion
- Oct 2017 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- 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.
Analysis of recent studies show that researchers find it hard to distinguish between Late Onset Depression, a first diagnosed major depressive episode which occurs at old age, and Early Onset Depression, a depressive episode at old age with a history of previous episodes. Since current data, about the phenomenology and etiology of Late Onset Depression, lake conicity it is unclear whether this phenomena should be considered as a distinct subtype of depression. Nevertheless, the wide spread assumption is that Late Onset Depression has a stronger correlation with brain damage and environmental risk factors such as the common losses at old age and weaker correlation with family history and genetics when compared to Early Onset. Although many researchers consider brain damage to have the main contribution to the emerge of Late Onset Depression, the fact that depression has a negative effect on one's health supports the claim that it might be the result and not the rick factor. Since Late Onset Depression correlates with the common losses at old age, the investigators propose that an existential approach that deals with one's meaning, freedom, responsibly and death, might be more appropriate. Thus, the investigators ask how do older adults experience depression which they face for the first time in old age? Current study will seek to understand older adults' experience of Late Onset depression through existential paradigm by using a semi constructed interview.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Late onset depression | – | Other: Interview |
Who may qualify
- Ages
- 62 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Israeli men and women after the age of retirement, 67 and 62 respectably, who are diagnosed with a major depressive episode, minor depressive episode or show depressive symptoms for the first time in their lives at old age.
Key inclusion criteria (3 listed)
- Men aged 67 or more, women aged 62 or more
- Diagnosis of Major Depressive Disorder, Minor Depressive Disorder or Adjustment Disorder with depressive features made after the age of 67 with men and 62 with women.
- Basic understanding and ability to converse in Hebrew.
Key exclusion criteria (6 listed)
- History of at least one previous major depressive or minor depressive episode before the age of 62 with women or 67 with men
- Mental Retardation or Autistic Spectrum Disorder
- Significant cognitive impairment observed by the primary physician.
- Schizophrenia or Schizoaffective disorder.
- Depressive episode with psychotic features
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 |
|---|---|---|
| InterviewEach subject will be interviewed using a semi constructed interview. | Other | Late onset depression |
Primary outcome
Data analysis
Time frame: 10 weeks
All the data collected, from each semi structured interview, will be analyzed by the investigator to find similarities or differences between the older adults' experience and to identify specific existential themes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MAjor Depressive Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
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 3 inclusion and 6 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 4 Jan 2017. 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 Israel. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data analysis (time frame: 10 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 4 Jan 2017.