DepressionNCT01284751
The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients
An observational study of Depression and Depressive Symptoms, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to measure depressive symptoms in breast cancer patients before surgery with Major Depression Inventory (MDI). The investigators hypothesize that this patient group will not produce scores correlating to having a mild, moderate or severe depression even though they have just recently… Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Depression, Depressive Symptoms
- What is being tested?
- MDI - self-rating inventory
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Mar 2011
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Department of Breast Surgery
Who may be able to join
- Women aged 30-70 years old, who are undergoing a lumpectomy or mastectomy
- ASA I-III
Who cannot join
- Planned or ongoing preoperative chemotherapy
- Known and treated sleep apnea syndrome
- Insulin treated diabetes mellitus
- Known or previous treated depressive illness or bipolar disorder
- Known autoimmune disease
- Incompensated cirrhosis
Show all 14Show fewer
- Other previous or ongoing cancer
- Known medically treated sleep disorder (insomnia, restless legs etc)
- Shift-work or night-work
- Daily alcohol intake of more than 5 units
- Preoperative treatment with psychopharmacological drugs, opioids or anxiolytics
- Predicted bad compliance
- Pregnant or breast feeding
- Preoperative MMSE score less than 24
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to measure depressive symptoms in breast cancer patients before surgery with Major Depression Inventory (MDI). The investigators hypothesize that this patient group will not produce scores correlating to having a mild, moderate or severe depression even though they have just recently experienced a major life crisis by receiving a malignant diagnosis.
Read the detailed description
The Major Depression Inventory is a self-rating depression scale with 12 questions. The questionnaire has previously been investigated in a Danish population. The scale contains the 10 ICD-10 (International Classification of Diseases)symptoms of depression and these symptoms are identical with the DSM-IV major depression symptoms with the exception of one symptom, low self-esteem, which in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) is incorporated in the symptom of guilt. On a six-point Likert scale, the individual items measure how much of the time the symptoms have been present during the last 14 days. The MDI is then scored according to specific guidelines and can be used as both a rating scale and a diagnostic instrument.
Patients will approximately one week after the diagnosis of breast cancer has been made, corresponding to approximately one week before surgery, be asked to complete the MDI. Patients therefore only complete the MDI once in the whole study. At the same time a Mini Mental State Examination (MMSE) and questions regarding previous illnesses and medication will be asked. Patients will not be followed up in any way.
- Conditions
- Depression, Depressive Symptoms
- Being tested
- MDI - self-rating inventory
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDI - self-rating inventoryOther
MDI with 12 questions to be completed approximately 1 week before surgery
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Patients aged 30-70 years having a lumpectomy or mastectomy at the Department of Breast Surgery at Herlev Hospital, Copenhagen, Denmark. Receives: Other: MDI - self-rating inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Total score on the Major Depression Inventory. When used as a diagnostic instruemtn patients witll according to the ICD-10 algorhythym be classified as mild, moderate or severe depression or no depression.
Measured: Approximately one week before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Melissa V Hansen, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284751
- Sponsor's protocol ID
- MVH-04
- Other IDs
- H-1-2010-FSP
- Status last verified
- May 2011
- First submitted
- 24 Jan 2011
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Olsen LR, Jensen DV, Noerholm V, Martiny K, Bech P. The internal and external validity of the Major Depression Inventory in measuring severity of depressive states. Psychol Med. 2003 Feb;33(2):351-6. doi: 10.1017/s0033291702006724.
PubMed 12622314Bech P, Rasmussen NA, Olsen LR, Noerholm V, Abildgaard W. The sensitivity and specificity of the Major Depression Inventory, using the Present State Examination as the index of diagnostic validity. J Affect Disord. 2001 Oct;66(2-3):159-64. doi: 10.1016/s0165-0327(00)00309-8.
PubMed 11578668Olsen LR, Mortensen EL, Bech P. Prevalence of major depression and stress indicators in the Danish general population. Acta Psychiatr Scand. 2004 Feb;109(2):96-103. doi: 10.1046/j.0001-690x.2003.00231.x.
PubMed 14725589
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01284751
- Acronym / sponsor ID
- MVH-04
- Conditions
- Depression, Depressive Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Jan 2011 (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.
The purpose of this study is to measure depressive symptoms in breast cancer patients before surgery with Major Depression Inventory (MDI). The investigators hypothesize that this patient group will not produce scores correlating to having a mild, moderate or severe depression even though they have just recently experienced a major life crisis by receiving a malignant diagnosis.
Detailed description
The Major Depression Inventory is a self-rating depression scale with 12 questions. The questionnaire has previously been investigated in a Danish population. The scale contains the 10 ICD-10 (International Classification of Diseases)symptoms of depression and these symptoms are identical with the DSM-IV major depression symptoms with the exception of one symptom, low self-esteem, which in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) is incorporated in the symptom of guilt. On a six-point Likert scale, the individual items measure how much of the time the symptoms have been present during the last 14 days. The MDI is then scored according to specific guidelines and can be used as both a rating scale and a diagnostic instrument.
Patients will approximately one week after the diagnosis of breast cancer has been made, corresponding to approximately one week before surgery, be asked to complete the MDI. Patients therefore only complete the MDI once in the whole study. At the same time a Mini Mental State Examination (MMSE) and questions regarding previous illnesses and medication will be asked. Patients will not be followed up in any way.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | Other: MDI - self-rating inventoryPatients aged 30-70 years having a lumpectomy or mastectomy at the Department of Breast Surgery at Herlev Hospital, Copenhagen, Denmark. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Breast Surgery
Key inclusion criteria (2 listed)
- Women aged 30-70 years old, who are undergoing a lumpectomy or mastectomy
- ASA I-III
Key exclusion criteria (14 listed)
- Planned or ongoing preoperative chemotherapy
- Known and treated sleep apnea syndrome
- Insulin treated diabetes mellitus
- Known or previous treated depressive illness or bipolar disorder
- Known autoimmune 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 |
|---|---|---|
| MDI - self-rating inventoryMDI with 12 questions to be completed approximately 1 week before surgery | Other | Breast cancer patients |
Primary outcome
Depressive symptoms
Time frame: Approximately one week before surgery
Total score on the Major Depression Inventory. When used as a diagnostic instruemtn patients witll according to the ICD-10 algorhythym be classified as mild, moderate or severe depression or no depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
- Background: PubMed 12622314Olsen LR, Jensen DV, Noerholm V, Martiny K, Bech P. The internal and external validity of the Major Depression Inventory in measuring severity of depressive states. Psychol Med. 2003 Feb;33(2):351-6. doi: 10.1017/s0033291702006724.
- Background: PubMed 11578668Bech P, Rasmussen NA, Olsen LR, Noerholm V, Abildgaard W. The sensitivity and specificity of the Major Depression Inventory, using the Present State Examination as the index of diagnostic validity. J Affect Disord. 2001 Oct;66(2-3):159-64. doi: 10.1016/s0165-0327(00)00309-8.
- Background: PubMed 14725589Olsen LR, Mortensen EL, Bech P. Prevalence of major depression and stress indicators in the Danish general population. Acta Psychiatr Scand. 2004 Feb;109(2):96-103. doi: 10.1046/j.0001-690x.2003.00231.x.
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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.
Melissa V Hansen, MD principal investigator
Herlev Hospital
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 Depression and Depressive Symptoms, run by Herlev Hospital at 1 site in Denmark.
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 2 inclusion and 14 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: finished, as of the sponsor's last update on 12 May 2011. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depressive symptoms (time frame: Approximately one week before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284751, which also lists 3 linked publications.
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 12 May 2011.