Health Condition 1: F334- Major depressive disorder, recurrent, in remission
Conditions
Interventions
Intervention1: Arm 1
Escitalopram 20 mg + Lactobacillus rhamnosus
: Intervention Description:
Tab. Escitalopram 20 mg orally once daily (baseline dose
may be tapered up to 5 mg based on clinical response and HAM-D scoring) + probiotic sachet containing Lactobacillus rhamnosus administered orally once daily for 8 weeks.
Duration of Intervention:
8 w
may be tapered up to 5 mg based on clinical response and HAM-D scoring) + probiotic sachet containing Bacillus coagulans administered orally once daily for 8 weeks. Duration of Intervention: 8 weeks R
Sponsors
Self
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients newly diagnosed with major depressive disorder as per DSM-V criteria. 2 Sex/Age: -Either sex from 18 55 years of age. 3. Patients willing to participate and comply with the follow-up visits and study procedures. 4. Patients who will give informed written consent. 5. HAM-D assessment score of more than 10 will be included.
Exclusion criteria
Exclusion criteria: 1. Patient already on any other antidepressant, antipsychotic or probiotic supplementation. 2. Past history of any substance abuse by the patient 3. Pregnant women 4. Intellectual disable and developmental delay patients 5. Patients with comorbidities like hypertension, uncontrolled diabetes, coronary artery disease, gastrointestinal disorders and any other organic disorder 6. All those who report any serious adverse drug reaction during the course of study will be treated accordingly and will be excluded from the study and will be analyzed separately
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in severity of depressive symptoms as assessed by change in HAM-D score.Timepoint: Baseline (Day 0), 2 weeks, 4 weeks, 6 weeks, and 8 weeks (final assessment at 8 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety by monitoring adverse drug reactions (ADRs) associated with probiotic strains and escitalopram using the Naranjo ADR Probability Scale.Timepoint: At baseline and at 2nd week, 4th week, 6th week, and 8th week follow-up visits. | — |
Countries
India
Contacts
Public ContactDr Amisha Rathee
Maharaja Agrasen Medical College, Agroha
Outcome results
None listed