To compare the efficacy of escitalopram versus escitalopram and melatonin combination therapy in treating major depressive disorder.

Comparative Efficacy of Escitalopram Monotherapy and Escitalopram-Melatonin Combination Therapy in Treating Major Depressive Disorder-A Randomized Interventional Study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070641

Enrollment

200

Registered

2024-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified

Interventions

Intervention1: Escitalopram and Melatonin: Tab Escitalopram 10 mg once daily in the morning and Tab Melatonin 3mg at night for total duration of 6 months. Control Intervention1: Tab Escitalopram 10 mg

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with MDD but without history of insomnia according to DSM V criteria. 2. Patients of either sexes above 18 years of age.

Exclusion criteria

Exclusion criteria: 1. Patients with organic cause of depression such as stroke, Alzheimer’s, Parkinsons, intracranial tumors, epilepsy etc. 2. Patients with severe depressive episodes with psychotic symptoms. 3. Pregnant and lactating females. 4. Patients in which these medications are contraindicated

Design outcomes

Primary

Measure	Time frame
1.To compare the efficacy of combination therapy of escitalopram and melatonin versus escitalopram alone in the treatment of MDD using Hamilton Depression Rating Scale (HDRS). 2.To compare the safety of the combination therapy of escitalopram and melatonin versus escitalopram monotherapy using AE (Adverse Event) and ADR (Adverse Drug Reaction) in adult patients of MDD. Timepoint: 3 months and 6 months	—

Measure

Time frame

1.To compare the efficacy of combination therapy of escitalopram and melatonin versus escitalopram alone in the treatment of MDD using Hamilton Depression Rating Scale (HDRS). 2.To compare the safety of the combination therapy of escitalopram and melatonin versus escitalopram monotherapy using AE (Adverse Event) and ADR (Adverse Drug Reaction) in adult patients of MDD. Timepoint: 3 months and 6 months

—

Secondary

Measure	Time frame
To assess the quality of life of patients of MDD taking escitalopram versus escitalopram and melatonin combination therapy using WHO BREF questionnaire.Timepoint: 3 months and 6 months	—

Countries

India

Contacts

Public ContactDr Sakshi Sharma

Indira Gandhi Medical College, Shimla (H.P.)

pkkaundal66@gmail.com9816120050

Outcome results

None listed

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