Evaluation of sertraline in depressed or anxious HSCT patients?
- Conditions
- Depression and anxiety.Depressive episode,Generalized anxiety disorderF32,F41.1
- Registration Number
- IRCT201310083210N4
- Lead Sponsor
- School of pharmacy,Research of deputy ,Shahid Beheshti University Of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Age between 18 to 60 ?years for allo-HSCT and auto-HSCT; presence of depression ?or based on Hospital Anxiety & Depression Scale (HADS) ; ?Stable & normal renal and liver function and ; Ability for oral ?taking of medication . Exclusion criteria: Patients with ?baseline kidney dysfunction (GFR less than 60 mL/min) ;Patients with ?abnormal LFT (bilirubin & ?aminotransferases level of more than 2 normal) ; Patient with sepsis or uncontrolled ?infection at baseline ; Patients unable to take orally ; Non-?cooporable patients with mental dysfunctionality ; pregnant or ?lactating women ; HIV+ patients ; Patients who who have taken ?antidepressant medication later than a month ago ;Intolerance of Sertraline adverse ?effects. ?
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression. Timepoint: Baseline 2 ,4, 8 and 12 weeks after. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire.;Anxiety. Timepoint: Baseline 2 ,4, 8 and 12 weeks after. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire.;IL-10 Inflammatort biomarker. Timepoint: Baseline, 2 and 4weeks after. Method of measurement: serum level pg/ml.;IL-6 inflammatory biomarker. Timepoint: Baseline, 4 and 8 weeks after. Method of measurement: Serum level pg / mL.;Hs-CRP inflammatory biomarker. Timepoint: Baseline, 4 and 8 weeks after. Method of measurement: Serum level mg / dl.
- Secondary Outcome Measures
Name Time Method Engraftment time. Timepoint: Daily until absolute neutrophil count (ANC) more than 500 and platelet more than 20000 for 3 consecutive days. Method of measurement: Cell blood count(CBC).