EUCTR2010-022460-12-DK
Active, not recruiting
Not Applicable
The effect of melatonin on depression, anxiety, cogntive function and sleep disturbances in breast cancer patients - MELODY
DrugsBio-Melatonin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Herlev Hospital
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women aged 30\-70 years who are admitted to have a lumpectomy or mastectomy at Herlev Hospital \- department F.
- •ASA score I\-III
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Known and treated sleep apnea syndrome
- •2\.Diabetes mellitus – treated with insulin
- •3\.Known depressive illness \- medically treated
- •4\.Previous medically treated depression or bipolar disorder
- •5\.Previous or ongoing cancer\-disease
- •6\.Other medically treated sleep disorders
- •7\.Shiftwork
- •8\.Pre\-operative treatment with psychopharmaceuticals (narcotics and sedatives)
- •9\.Pregnant or breastfeeding women
- •10\.Pre\-operative mini mental state examination score (MMSE) \< 24
Outcomes
Primary Outcomes
Not specified
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