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

This study has been completed.
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01284751
First received: January 24, 2011
Last updated: May 11, 2011
Last verified: May 2011

January 24, 2011
May 11, 2011
January 2011
March 2011   (final data collection date for primary outcome measure)
Depressive symptoms [ Time Frame: Approximately one week before surgery ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01284751 on ClinicalTrials.gov Archive Site
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The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients
The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Department of Breast Surgery

  • Depression
  • Depressive Symptoms
Other: MDI - self-rating inventory
MDI with 12 questions to be completed approximately 1 week before surgery
Breast cancer patients
Patients aged 30-70 years having a lumpectomy or mastectomy at the Department of Breast Surgery at Herlev Hospital, Copenhagen, Denmark.
Intervention: Other: MDI - self-rating inventory

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Female
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01284751
MVH-04, H-1-2010-FSP
No
M.D. Melissa Voigt Hansen, Herlev Hospital - Department of surgical gastroenterology
Herlev Hospital
Not Provided
Principal Investigator: Melissa V Hansen, MD Herlev Hospital
Herlev Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP