Health Condition 1: F331- Major depressive disorder, recurrent, moderate Health Condition 2: F321- Major depressive disorder, singleepisode, moderate Health Condition 3: F322- Major depressive disorder, singleepisode, severe without psychotic features
Conditions
Interventions
Intervention1: Melatonin: Melatonin 6 mg orally at bedtime + standard SSRI therapy.
Control Intervention1: Placebo: Placebo orally at bedtime + standard SSRI therapy.
Sponsors
Dr. Yuvraj Rathore
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with Major Depressive Disorder as per DSM 5 criteria. 2. HAM D score is equal or greater than 17. 3. Willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Bipolar disorder, schizophrenia, or any other major psychiatric comorbidity. 2. Substance abuse within the last 6 months. 3. Severe suicidal ideation or attempt. 4. Use of melatonin, benzodiazepines, or antipsychotics in past 2 weeks. 5. Pregnancy or lactation. 6. Known hypersensitivity to melatonin. 7. Severe hepatic or renal impairment or with any other major physical comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HAM-D score from baseline to week 8 (clinician-rated depression severity).Timepoint: Baseline. Week 2, 4 and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PSQI score from baseline to week 8 (sleep quality).Timepoint: Baseline. Week 2, 4 and 8;Change in PHQ-9 score from baseline to week 8 (self-reported depression severity)Timepoint: Baseline. Week 2, 4 and 8;Change in WHOQOL-BREF scores from baseline to week 8 (quality of life).Timepoint: Baseline and Week 8;Frequency and type of adverse events (AEs).Timepoint: Throughout the study period. | — |
Countries
India
Contacts
Public ContactDr Gaurav Gulrez
Government Medical College, Dungarpur
Outcome results
None listed