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

NCT05315401 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National University of Malaysia

    collaborator OTHER

  • Min-Tze LIONG

    lead OTHER

Principal Investigators

  • Min Tze Liong, Prof.Dr · School of Industrial Technology, University of Science Malaysia

  • Luke Woon Sy-Cherng, Dr · Department of Psychiatry Hospital Canselor Tuanku Muhriz UKM medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Malaysia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05315401 on ClinicalTrials.gov