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CompletedNCT01284751Updated May 12, 2011

The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients

An observational study in Depression and Depressive Symptoms, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to female participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-05-12.

Sponsored by Herlev Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
21
Ages
30 Years to 70 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Depression
  • Depressive Symptoms

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03

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 21 is below the median of 158 across 1,111 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Herlev Hospital is the lead sponsor of 201 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Department of Breast Surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women aged 30-70 years old, who are undergoing a lumpectomy or mastectomy
  • ASA I-III

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
21 participants (actual)

Groups and cohorts

  • Breast cancer patients

    Patients aged 30-70 years having a lumpectomy or mastectomy at the Department of Breast Surgery at Herlev Hospital, Copenhagen, Denmark.

    Other: MDI - self-rating inventory

Interventions

  • OtherMDI - self-rating inventory

    MDI with 12 questions to be completed approximately 1 week before surgery

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately one week before surgery

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Study locations

1 site
  • Herlev Hospital
    Herlev, 2730, Denmark
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References and documents

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 12622314 ↗
  • Bech 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 11578668 ↗
  • Olsen 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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Mar 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2011
First posted
Jan 27, 2011
Start
Jan 2011
Primary completionActual
Mar 2011
CompletionActual
Mar 2011
Last update
May 12, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01284751
Lead sponsor
Herlev Hospital
First posted
Jan 27, 2011
Start date
Jan 2011
Primary completion
Mar 2011
Completion
Mar 2011
Last update
May 12, 2011

Study contacts

Melissa V Hansen, MD
principal investigator · Herlev Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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