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

Phase 2/3

Not yet recruiting

Conditions: Major depressive disorder, recurrent, mild,

Registration Number: CTRI/2020/12/030020

Lead Sponsor: Pulse Pharmaceuticals Pvt Ltd

Brief Summary: Participants were randomly assigned to receive either Vitamin D or placebo. Participants will be provided with 12 weeks of study medication. Vitamin D will be given as DEKEL Nano Syrup once a day for 10-days. Apart from Vitamin D, both groups will receive treatment as usual including prescription of Escitalopram 10 mg or 20 mg, along with Clonazepam and a proton pump inhibitor (PPI). Both groups will also undergo psychiatric examination with diagnostic interview, cognitive behavior therapy, psycho-education and any other medication according to the treatment guidelines.

**Randomization and Blinding**

The participants will be randomized into two groups, intervention (Vitamin D with Standard Treatment) or control (Standard Treatment only) using blocks of four. The randomization procedure will be computer-generated and conducted in a labelling procedure concealed from the staff and investigators. Both the active drug and the placebo will be identical in size, smell, and taste.

**Outcome Measures**

Â· **Primary Outcome:**

1. Sum of the Hamilton Rating Scale for Depression (17-items) (HAM-D17).

2. Score in Montgomery-Asberg Depression Rating Scale (MADRS).

**Secondary Outcome:**

1.Clinicians Global Impressions (CGI) Score

2. Incidence of adverse events.

**Study Assessments:**

Depression level and mental health will beassessed and diagnosed by an experienced Psychiatrist. The primary outcome willbe assessed using HAM-D17 and MADRS whereas the secondary outcomes are assessed using CGIand the incidence of adverse events. All outcomes will be assessed at baselineand at the end of 3 months. Socio-demographic factors will be assessed at baseline. Known side effects of vitamin D supplementation, and severe adverse events, use of dietary supplements and a full medication list are recorded at baseline and follow-up.

Treatment adherence will be assessed by counting the number of bottles returned by the patients at 12 weeks.

25(OH) D, phosphate, calcium, PTH, HbA1c, TSH, T3 and T4 will be estimated, at baseline and then at the end of three months.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

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

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 Î¼g 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.
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 MADRS	At baseline, 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.Clinicians Global Impressions (CGI) Score	2.Incidence of adverse events.

Trial Locations

Locations (1): Asha Hospital
🇮🇳
Hyderabad, TELANGANA, India
Asha Hospital
🇮🇳Hyderabad, TELANGANA, India
Dr G Prasad Rao
Principal investigator
9121106683
prasad40@gmail.com