Evaluation the Effect of Agomelatine on Sleep, Anxiety, Depression, Appetite and Fatigue in Hematopoietic Stem Cells Transplant Recipients
- Conditions
- Patients with various Blood Malignancies who are candidates for Hematopoietic Stem Cell Transplantation..Hodgkin lymphoma
- Registration Number
- IRCT20100127003210N28
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Patients' satisfaction to enter the study
Patients aged more than 18 years and less than 75 years old who are candidates for bone marrow stem cell transplantation.
Weight of at least 40 kg
Creatinine clearance = 30 mL/min due to renal elimination of drug metabolites
Liver enzymes (ALT, AST) less than three times the upper limit of normal
If the patients suffer from anxiety or depression, they are equally divided into two groups, case and control.
Patients' lack of consent to enter the study
Pregnancy and breastfeeding
History of allergy to agomelatine or any of the components of the drug formulation
History of underlying liver, kidney, thyroid disorders and untreated anemia in patients
History of bipolar disorder, mania and hypomania
Taking drugs that affect appetite, such as vitamins of group B and zinc
Consumption of stimulants such as amphetamine derivatives, or consumption of narcotic drugs
Simultaneous use of drugs with significant interactions with agomelatine, such as rifampin, ciprofloxacin, and fluvoxamine.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method