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

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. Read our disclaimer for details. Identifier: NCT01284751
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : May 12, 2011
Information provided by:
Herlev Hospital

Brief 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.

Condition or disease Intervention/treatment
Depression Depressive Symptoms Other: MDI - self-rating inventory

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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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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
MDI with 12 questions to be completed approximately 1 week before surgery

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Department of Breast Surgery

Inclusion Criteria:

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

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

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 identifier (NCT number): NCT01284751

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Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
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Principal Investigator: Melissa V Hansen, MD Herlev Hospital

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Responsible Party: M.D. Melissa Voigt Hansen, Herlev Hospital - Department of surgical gastroenterology Identifier: NCT01284751     History of Changes
Other Study ID Numbers: MVH-04
H-1-2010-FSP ( Other Identifier: The Danish Ethics Committee )
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders