A phase-III clinical trial to study the effects of vitamin D3 add on therapy with escitalopram in depression.

Randomized, double-blind, placebo-controlled trial on the impact of vitamin D supplementation on treatment and outcome of depression

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027428

Enrollment

Registered

2020-08-27

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: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: vitamin D: Oral vitamin D capsule (50,000 IU every 5 days for 12 weeks Control Intervention1: Placebo: Identical oral dummy placebo capsule once in 5 days for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: No antidepressant and antipsychotic exposure for the past 2 months Serum 25-hydroxy vitamin D levels score of >= 15 on the 17-item Hamilton Depression Rating Scale

Exclusion criteria

Exclusion criteria: Other psychiatric disorders Pregnancy and lactation Concurrent major life-threatening illness like malignancy, cardiac failure, renal failure etc Suicidal patients Alcohol and substance abuse and smokers

Design outcomes

Primary

Measure	Time frame
17-item Hamilton Depression Rating Scale scoreTimepoint: Change from baseline to 4th, 8th and 12th weeks	—

Secondary

Measure	Time frame
Montgomery Asberg Depression Rating Scale Beck Depression Inventory scoreTimepoint: baseline, 4th, 8th and 12th weeks	—

Countries

India

Contacts

Public ContactDrPNSuresh Kumar

IQRAA International Hospital and Research Center

drpnsuresh@gmail.com04952379246

Outcome results

None listed

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