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Effect of Agomelatine and Sertraline on Major Depressive Disorders in Patient with Chronic Kidney Disease: A Double-Blinded Randomized Controlled Trial

Effect of Agomelatine and Sertraline on Major Depressive Disorders in Patient with Chronic Kidney Disease: A Double-Blinded Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200319005
Enrollment
Unknown
Registered
2020-03-19
Start date
2019-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Major depressive disorder in chronic kidney disease Major depressive disorders&#44

Interventions

Sertraline&#44
a standard antidepressant for CKD patients in Thai depression guideline,Agomelatine&#44
a novel antidepressant
Active Comparator Drug,Experimental Drug
Sertraline,Agomelatine

Sponsors

Phramongkutklao Hospital
Lead Sponsor
Phramongkutklao Hospital
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Change of depression score 8 weeks Thai HRSD

Secondary

MeasureTime frame
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&#45;9 8 weeks PHQ&#45;9 score,Quality of life 8 weeks WHOQoL BREF THAI

Countries

Thailand

Contacts

Public ContactFadhil Saleh&#45;arong

Phramongkutklao Hospital

fadhil2internist@gmail.com(66)91 717 1347

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026