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DEKSEL Nano Syrup [Vitamin D 6000IU/5mL] in patients with Major Depressive Disorder

A Double Blind Study to Assess Efficacy of Add-on Vitamin D over Escitalopram in Major Depressive Disorder

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030020
Enrollment
70
Registered
2020-12-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: F330- Major depressive disorder, recurrent, mild

Interventions

Intervention1: DEKSEL: Cholicalciferol OR VITAMIN-D3 60000IU/5ml Control Intervention1: PLACEBO: Plain syrup OF 5ml

Sponsors

Pulse Pharmaceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients suffering from mild to severe depression. 2.18â??65 Years of age, of either gender. 3.Willing to give signed Informed Consent.

Exclusion criteria

Exclusion criteria: 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 100 nmol/L, serum calcium (ionized) >1.40 mmol/L, estimated glomerular filtration rate (eGFR) 49 years), or serum parathyroid hormone (PTH) >9.2 pmol/L.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be assessed using HAM-D17 and MADRSTimepoint: At baseline, 12 weeks

Secondary

MeasureTime frame
1.Clinicians Global Impressions (CGI) Score 2.Incidence of adverse events. Timepoint: 90 DAYS

Countries

India

Contacts

Public ContactDr G Prasad Rao

ASHA HOSPITAL

prasad40@gmail.com9121106683

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026