Health Condition 1: F331- Major depressive disorder, recurrent, moderate
Conditions
Interventions
Intervention1: Aceclofenac Tablet [with standard therapy Escitalopram (10-20 mg/day) or Sertraline (50-100 mg/day)]: 100 mg twice daily for 12 weeks
Intervention2: Fixed-dose combination of Aceclofena
Sponsors
Dr Sunita Goswami
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of 18-65 years of age, both inclusive 2. Patient with diagnosis of major depressive disorder (based on DSM-V criteria) 3. Patient with Hamilton Depression Rating Scale (HAM-D17) score 8 to 18 (both inclusive) (mild to moderate depression) at screening and enrolment 4. Patient on stable treatment with escitalopram (10-20 mg/day) or sertraline (50-100 mg/day) since last 4 weeks (minimum) and/or patient with inadequate response to escitalopram or sertraline as per investigatorâ??s discretion 5. Patient willing to give written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patient with a history of hypersensitivity to aceclofenac or serratiopeptidase or escitalopram/citalopram or sertraline or its excipients 2. Patient with history of GI bleeding/perforation or active/suspected gastrointestinal ulcer within the past 2 years prior to screening 3. Patient with history of clinically significant renal or hepatic impairment prior to screening as per investigator discretion 4. Patient with history of angle closure glaucoma, mania/hypomania, hyponatremia, psychotic symptoms, or other DSM-IV axis I and II psychiatric disease or physical co-morbidity 5. Patient with active or recent (within past 2 months) infection at screening (temperature > 100.30C or total WBC count > 11000/microL based on past history will be considered as active infection even in the absence of other symptoms) 6. Alcohol or substance use disorder except nicotine and caffeine within the past 6 months prior to screening 7. Patient with active suicidal ideation or high risk of suicide (patient who score > 2 on suicidal item of HAM-D17 or who will be judged to have significant suicidal potential in the view of investigator) 8. History of clinically significant thyroid disease, hematological disease, CNS disease, seizure disease, gastrointestinal disease, cardiovascular/thromboembolic disease, respiratory disease, immune system disease/autoimmune disease, skin disease, diabetes mellitus, gout or any other concurrent medical illness which may compromises the safety of patient or interfere with study outcome or contraindicate the use of study medication (aceclofenac-/serratiopeptidase or escitalopram or sertraline) as per investigator opinion prior to screening 9. Patient currently being treated with steroids, immunomodulating agents, MAO inhibitors, pimozide, linezolide, vitamin B complex supplements, serotonergic agents except escitalopram, quinolone antibiotics, sulfonylurea, or any other concomitant agents which may compromises safety of patient or interfere with study outcome or contraindicate the use of study medication (aceclofenac-/Serratiopeptidase or escitalopram or sertraline) within the past 4 weeks prior to screening 10. Patient currently being treated with psychotherapy or any other non-pharmacological therapy (cognitive behaviour therapy, electroconvulsive therapy, sleep deprivation, trans-cranial magnetic stimulation etc.) within the past 4 weeks prior to screening 11. Pregnant or lactating women 12. Women of child bearing age who do not agree to use an approved method of contraception during the study 13. Patient is either unable to cooperate or unlikely to adhere with any study procedures in an opinion of investigator 14. Patient who have participated in any other clinical trial within the past 4 weeks of the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in HAM-D17 scoreTimepoint: Week 0 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression-Improvement assessmentTimepoint: Week 12;Mean Change in biomarker levels (quinolinic acid, IL-6, cortisol) in bloodTimepoint: week 0 and week 12;Mean Change in Clinical Global Impression-Severity of IllnessTimepoint: week 0 and week 12;Mean Change in HAM-D17 scoreTimepoint: week 4, week 8;Mean Change in MADRS (Montgomery â??Asberg Depression Rating Scale) total score Timepoint: Week 0 and Week 12;Remission rate (HAM-D17 score â?¤7)Timepoint: week 12;Response rate/Treatment responseTimepoint: week 4, week 8 and week 12 | — |
Countries
India
Contacts
Public ContactHardikkumar Dodiya
L M College of Pharmacy
Outcome results
None listed