Back to resultsThe Efficacy of Probiotic Compared With Placebo Commitment Therapy for Treatment of Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Withdrawn
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Probiotic
Placebo
Acceptance and commitment therapy (ACT)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Probiotics
Eligibility Criteria
Inclusion Criteria:
- Female patient diagnosed with major depressive disorder (confirmed by DSM-5 for depression). There is a strong gender predisposition in depression and anxiety disorders, in which females are more prone to have depressive disorders and anxiety disorders than males. Hence, we will only recruit female patients in this study to control for confounding bias.
- Those with score of more than 8 based on Hamilton Depression Rating Scale (HAMD), indicative of mild to moderate severity of depressive symptoms.
- Age 18 to 35 years old
Exclusion Criteria:
- Pregnant women
- Those who have current and lifetime history of engaging in any psychotherapy
- Those who consumed alcohol and illicit drugs (Heavy or mild)
- Those who has current and lifetime history of other psychiatric illnesses, such as other depressive disorders (persistent depressive disorder, premenstrual dysphoric disorder), anxiety disorders (panic disorder, agoraphobia, generalized anxiety disorder, specific anxiety disorder, and social anxiety disorder), psychotic disorders (schizophrenia, schizophreniform disorder, schizoaffective disorders, brief psychotic disorder, and delusional disorder), bipolar mood disorder, obsessive compulsive disorder, posttraumatic stress disorder, and attention deficit hyperactive disorder, and autism spectrum disorder
- Those who are on medications that can induce psychiatric symptoms, such as cardiovascular agents (clonidine, guanethidine, methyldopa, reserpine, beta blockers), dermatologic agents (isotretinoin), anticonvulsants (levetiracetam), antimigraine medications (triptans), hormonal agents (corticosteroids, oral contraceptives, gonadotropin-releasing hormone agonists, tamoxifen), varenicline, immunological agents (interferons), and levodopa
- Severe gastritis with regular intake omeprazole medication (proton pump inhibitors)
- Women on regular steroid treatment
- Those on long term medication for any illnesses (≥ 6 months)
- Those who are currently on antibiotics or with history of taking antibiotic for the past 2 weeks.
- Those with abnormal full blood count, renal profile, liver function test, fasting blood glucose, fasting lipid profile and ESR (blood collection for all these blood investigations will be carried out in the pre-intervention assessment).
- Patient who has suicidal tendency
Sites / Locations
- Hospital Canselor Tuanku Muhriz UKM Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Probiotic 9 log CFU/day
Placebo
Acceptance and commitment therapy (ACT)
Arm Description
The intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.
placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as a light-yellow powder.
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
Outcomes
Primary Outcome Measures
differences in severity of depression in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
To evaluate differences in severity of depression via the use of the Montgomery and Åsberg (MADRS) Depression Rating Scale questionnaire containing 10-items on a 7-point scale with higher scores indicating more severe depression
Secondary Outcome Measures
differences in quality of life in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
To evaluate differences in quality of life via the use of the RAND-36 questionnaire containing 36-items on a varying point scale including some items with reverse scoring, with higher scores indicating better health status.
differences in blood depression biomarkers in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
To evaluate differences in depression blood biological markers such as BDNF, TNF-α, IL-6, IL-1β, CRP, and VEGF via measuring concentrations using commercially available ELISA kit.
differences in gut microbiota profiles of patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
To evaluate differences in gut microbiota profiles via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.
Full Information
NCT ID
NCT05315401
First Posted
March 30, 2022
Last Updated
May 8, 2023
Sponsor
Min-Tze LIONG
Collaborators
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT05315401
Brief Title
The Efficacy of Probiotic Compared With Placebo Commitment Therapy for Treatment of Major Depressive Disorder
Official Title
The Efficacy of Probiotic Compared With Placebo and Acceptance and Commitment Therapy for the Treatment of Major Depressive Disorder Among Adult Females
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Fail to recruit
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min-Tze LIONG
Collaborators
National University of Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
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).
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A double-blind three-armed randomized controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria
Masking
ParticipantCare ProviderInvestigator
Masking Description
. The randomization will be performed by the study statistician, who had no contact with the patients and not involve in the research project. The allocation sequence will not be available to any member of the research team until databases had been completed and locked. Since this is a double-blinded study, both the research team and subject will not know in which group the subject is assigned to.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic 9 log CFU/day
Arm Type
Experimental
Arm Description
The intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as a light-yellow powder.
Arm Title
Acceptance and commitment therapy (ACT)
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and commitment therapy (ACT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
differences in severity of depression in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
Description
To evaluate differences in severity of depression via the use of the Montgomery and Åsberg (MADRS) Depression Rating Scale questionnaire containing 10-items on a 7-point scale with higher scores indicating more severe depression
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
differences in quality of life in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
Description
To evaluate differences in quality of life via the use of the RAND-36 questionnaire containing 36-items on a varying point scale including some items with reverse scoring, with higher scores indicating better health status.
Time Frame
24 weeks
Title
differences in blood depression biomarkers in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
Description
To evaluate differences in depression blood biological markers such as BDNF, TNF-α, IL-6, IL-1β, CRP, and VEGF via measuring concentrations using commercially available ELISA kit.
Time Frame
24 weeks
Title
differences in gut microbiota profiles of patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
Description
To evaluate differences in gut microbiota profiles via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.
Time Frame
24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patient diagnosed with major depressive disorder (confirmed by DSM-5 for depression). There is a strong gender predisposition in depression and anxiety disorders, in which females are more prone to have depressive disorders and anxiety disorders than males. Hence, we will only recruit female patients in this study to control for confounding bias.
Those with score of more than 8 based on Hamilton Depression Rating Scale (HAMD), indicative of mild to moderate severity of depressive symptoms.
Age 18 to 35 years old
Exclusion Criteria:
Pregnant women
Those who have current and lifetime history of engaging in any psychotherapy
Those who consumed alcohol and illicit drugs (Heavy or mild)
Those who has current and lifetime history of other psychiatric illnesses, such as other depressive disorders (persistent depressive disorder, premenstrual dysphoric disorder), anxiety disorders (panic disorder, agoraphobia, generalized anxiety disorder, specific anxiety disorder, and social anxiety disorder), psychotic disorders (schizophrenia, schizophreniform disorder, schizoaffective disorders, brief psychotic disorder, and delusional disorder), bipolar mood disorder, obsessive compulsive disorder, posttraumatic stress disorder, and attention deficit hyperactive disorder, and autism spectrum disorder
Those who are on medications that can induce psychiatric symptoms, such as cardiovascular agents (clonidine, guanethidine, methyldopa, reserpine, beta blockers), dermatologic agents (isotretinoin), anticonvulsants (levetiracetam), antimigraine medications (triptans), hormonal agents (corticosteroids, oral contraceptives, gonadotropin-releasing hormone agonists, tamoxifen), varenicline, immunological agents (interferons), and levodopa
Severe gastritis with regular intake omeprazole medication (proton pump inhibitors)
Women on regular steroid treatment
Those on long term medication for any illnesses (≥ 6 months)
Those who are currently on antibiotics or with history of taking antibiotic for the past 2 weeks.
Those with abnormal full blood count, renal profile, liver function test, fasting blood glucose, fasting lipid profile and ESR (blood collection for all these blood investigations will be carried out in the pre-intervention assessment).
Patient who has suicidal tendency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Tze Liong, Prof.Dr
Organizational Affiliation
School of Industrial Technology, University of Science Malaysia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luke Woon Sy-Cherng, Dr
Organizational Affiliation
Department of Psychiatry Hospital Canselor Tuanku Muhriz UKM medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Canselor Tuanku Muhriz UKM Medical Centre
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
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The Efficacy of Probiotic Compared With Placebo Commitment Therapy for Treatment of Major Depressive Disorder
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