Effect of Agomelatine and Sertraline on Major Depressive Disorders in Patient with Chronic Kidney Disease: A Double-Blinded Randomized Controlled Trial
- Conditions
- Major depressive disorder in chronic kidney diseaseMajor depressive disorders,chronic kidney disease,depression,agomelatine,sertraline
- Registration Number
- TCTR20200319005
- Lead Sponsor
- Phramongkutklao Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
1. CKD stage 3 †5
2. Diagnosed MDD by psychiatrist
3 Age ≥ 18 years
4. Performed PHQ-9 score ≥ 7
. Performed Thai HRSD ≥ 8
6. Give written an informed consent
1. Previous diagnosed with depressive disorders & other psychiatric disorders (Esp. Schizophrenia, Bipolar disorder)
2. History of previous antidepressants treatment
3. Severe depression who needs hospitalization
4. Used the following of drugs : Fluvoxamine, MAO inhibitors, Pimozide, Cimethidine, Ciprofloxacin, Ticlopidine, anti-arrhythmic drug 1C, anti-epileptic drugs, Tramadol, Tryptophan, St. John’s wort
5. History of allergy to Agomelatine & Sertraline
6. Patients in comatose or emergency state
7. History of previous kidney transplantation
8. Medical history of COPD, Alzheimer’s dz, end stage of malignancy
9. History of alcoholism or substance used
10. Liver enzyme impairment 3-fold increased
11. Pregnant or breast feeding woman
12. Suicide score (PHQ-8) ≥ 17
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of depression score 8 weeks Thai HRSD
- Secondary Outcome Measures
Name Time Method Responsiveness of antidepressant 8 weeks Change of Thai HRSD > 50%,Remission of depression 8 weeks Thai HRSD score < 8,Remission of depression 8 weeks Thai HRSD score < 8,Change of PHQ-9 8 weeks PHQ-9 score,Quality of life 8 weeks WHOQoL BREF THAI