DEKSEL Nano Syrup [Vitamin D 6000IU/5mL] in patients with Major Depressive Disorder
- Conditions
- Health Condition 1: F330- Major depressive disorder, recurrent, mild
- Registration Number
- CTRI/2020/12/030020
- Lead Sponsor
- Pulse Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients suffering from mild to severe depression.
2.18â??65 Years of age, of either gender.
3.Willing to give signed Informed Consent.
1.Patients suffering from bipolar affective disorder, any form of schizophrenia, tuberculosis, and sarcoidosis.
2.Pregnant or lactating women.
3.Intake of more than 10 μg vitamin D daily.
4.Known allergy, intolerance or contraindication to study medication.
5.Women of childbearing potential not willing to utilize effective contraception. A negative human chorionic gonadotropin (HCG) pregnancy test is required.
6. Patients were excluded if they at baseline had: serum 25(OH)D <10 nmol/L or >100 nmol/L, serum calcium (ionized) >1.40 mmol/L, estimated glomerular filtration rate (eGFR) <60 mL/min/1.72 m2, serum phosphate <1.50 mmol/L (females) and <1.60 mmol/L (males aged between 18-49 years) or <1.35 mmol/L (males >49 years), or serum parathyroid hormone (PTH) >9.2 pmol/L.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be assessed using HAM-D17 and MADRSTimepoint: At baseline, 12 weeks
- Secondary Outcome Measures
Name Time Method 1.Clinicians Global Impressions (CGI) Score <br/ ><br>2.Incidence of adverse events. <br/ ><br>Timepoint: 90 DAYS