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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01284751 |
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Date of registration:
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24/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients
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Scientific title:
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The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01284751 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Melissa V Hansen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Herlev Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Depressive Symptoms
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Depression
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Intervention(s)
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Other: MDI - self-rating inventory
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Primary Outcome(s)
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Depressive symptoms
[Time Frame: Approximately one week before surgery]
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Secondary ID(s)
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MVH-04
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H-1-2010-FSP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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