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Efficacy and safety of Morinda officinalis oligosaccharide combined with probiotics in the treatment of major depressive disorder

Efficacy and safety of Morinda officinalis oligosaccharide combined with probiotics in the treatment of major depressive disorder: A double-blind randomized placebo-controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055780
Enrollment
Unknown
Registered
2022-01-19
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

test group :Morinda officinalis oligosaccharide capsules combined with probiotics
placebo group:Morinda officinalis oligosaccharide capsules combined with placebo

Sponsors

Beijing Anding Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for major depressive disorder in the American Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5), with either first episode or relapse, without psychotic symptoms; 2. Aged 18 to 65 years, male or female; 3. 14 = 5; 5. At least 3 symptom scores between 4 and 6 on the GSRS scale (moderate to severe discomfort); 6. The subjects can understand and comply with the research requirements and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who are currently or previously diagnosed with other disorders than major depressive disorder according to the MINI; 2. Current or past substance abuse; 3. Subjects who have received any surgical treatment, vagus nerve stimulation, deep brain stimulation treatment or stem cell treatment for depression; 4. Patients currently undergoing MECT and other physical therapy; 5. The patient currently has a serious risk of suicide, and the HAMD-17 suicide risk item is >= 3; 6. Subjects with unstable physical diseases that require medical or surgical treatment; 7. Suffering from inflammation, tumor, autoimmune disease, diabetes; 8. Gastrointestinal organic diseases with gastrointestinal inflammation, infection, tumor and other structural abnormalities; 9. Use of any antibiotics, probiotic products and laxatives within 1 month before entering the study; 10. Those who have been allergic or ineffective when taking Morinda officinalis oligosaccharide capsules in the past; 11. Patients who are using antipsychotics, antidepressants and mood stabilizers with less than 5 half-lives.

Design outcomes

Primary

MeasureTime frame
HAMD total score deduction value;

Secondary

MeasureTime frame
difference in efficiency;Changes in the total score on the GAD-7 scale;Changes in blood and stool indexes;Changes in the total score of GSRS and CAS;Early efficiency;

Countries

China

Contacts

Public ContactWang Gang

Beijing Anding Hospital affiliated to Capital Medical University

gangwangdoc@ccmu.edu.cn+86 13911695727

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026