drugset / Trial / NCT01355523
The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients
Phase 2/3
Terminated
54 enrolled
Melissa Voigt Hansen
Pharma Nord · collabRigshospitalet, Denmark · collabUniversity of Copenhagen · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to investigate the effect of 6 mg melatonin daily for 1 week preoperatively to 12 weeks postoperatively on depressive symptoms, anxiety, cognitive function and sleep disturbances in breast cancer patients. Furthermore the investigators will examine whether a specific clock-gene (HPER3) is correlated with an increased risk of depression, sleep disturbances or cognitive dysfunction.
Timeline
- Start
- 2011-07
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melatonin | Small molecule | 6 mg | Oral |