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The effect of melatonin on depression, anxiety, cogntive function and sleep disturbances in breast cancer patients - MELODY

The effect of melatonin on depression, anxiety, cogntive function and sleep disturbances in breast cancer patients - MELODY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-022460-12-DK
Enrollment
Unknown
Registered
2011-02-11
Start date
2011-03-23
Completion date
Unknown
Last updated
2013-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Anxiety Postoperative cognitive dysfunction Sleep disturbances MedDRA version: 12.1 Level: LLT Classification code 10012378 Term: Depression MedDRA version: 12.1 Level: LLT Classification code 10002855 Term: Anxiety MedDRA version: 12.1 Level: LLT Classification code 10009845 Term: Cognitive disturbance MedDRA version: 12.1 Level: LLT Classification code 10040997 Term: Sleep disturbances

Interventions

Trade Name: Bio-Melatonin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Melatonin CAS Number: 73-31-4 Other descriptive name: MELATONIN Concentration unit: mg milligram(s) Concentration

Sponsors

Herlev Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 11. Planned or on-going preoperative chemotherapy

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate if melatonin has an effect on depressive symptoms measured by MDI (Major Depression Inventory) in breast cancer patients;Secondary Objective: To investigate if melatonin has an effect on anxiety, cognitive dysfunction and sleep disturbances in breast cancer patients;Primary end point(s): Major Depression Inventory (MDI) to determine depressive symptoms—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026