NCT05315401

The Efficacy of Probiotic Compared With Placebo Commitment Therapy for Treatment of Major Depressive Disorder

The Efficacy of Probiotic Compared With Placebo and Acceptance and Commitment Therapy for the Treatment of Major Depressive Disorder Among Adult Females

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Min-Tze LIONG · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity of depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via the use of questionnaires.

Detailed description

1. To assess the differences in quality of life among patients on probiotic, placebo and ACT via the use of questionnaire, at 4 timelines (baseline, 6 weeks after starting intervention, 12 weeks after starting intervention, and 24 weeks after starting intervention which is 12 weeks post-termination of intervention). 2. To assess the differences in blood biological markers such as BDNF, TNF-α, IL-6, IL-1β, CRP, and VEGF among patients on probiotic, placebo and ACT via blood biochemical analyses, at 4 timelines (baseline, 6 weeks after starting intervention, 12 weeks after starting intervention, and 24 weeks after starting intervention which is 12 weeks post-termination of intervention). 3. To assess the differences in gut microbiota profiles of patients on probiotic, placebo and ACT via the use of fecal samples, at 3 timelines (baseline, 12 weeks after starting intervention, and 24 weeks after starting intervention which is 12 weeks post-termination of intervention).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	This project aims to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via use of questionnaires.
DIETARY_SUPPLEMENT	Placebo	This project aims to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via use of questionnaires.
BEHAVIORAL	Acceptance and commitment therapy (ACT)	Patients will be provided with ACT for 12 weeks with treatment as usual. The ACT intervention will be conducted in a group of 10 for each session. The ACT modules covered over 12 sessions, 1 hour in each session. The sessions will be held every week.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-04-07
• Last updated: 2023-05-10

Locations

1 site across 1 country: Malaysia