The effect of lactosucrose in patients with depressio
- Conditions
- Depressive episode in ICD-10depression
- Registration Number
- JPRN-jRCTs051180163
- Lead Sponsor
- Tarutani Seiichiro
- Brief Summary
ong-term use of LS may improve self-efficacy in depressed patients. On the other hand, it is possible that the treatment response in outpatients may have differed due to differences in meal content. Based on the result of this study, an additional study that a multi-centored RCT in an environment where the meal content is unified and the adherence can be strictly confirmed is needed to prove the effectiveness for depression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
1. Outpatients with depression (ICD-10: F32) treated at Osaka Institute of Clinical Psychiatry, Shin-Abuyama Hospital.
2. Subjects who had some mood symptoms between 2 to 5 in CGI-S (Clinical Global Impression-Severity Scale).
1. subjects who do not accept the informed consent.
2. subjects who routinely take probiotics or probiotics.
3. Subjects who had dementia.
4. Subjects who had mental retardation.
5. Subjects who had inflammatory bowel disease like ulcerative colitis or Crohn's disease.
6. Subjects who had history of taking antibiotics within two weeks of consent acquisition.
7. Subjects who had history of diarrhea within two weeks of consent acquisition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total MADRS score improvement
- Secondary Outcome Measures
Name Time Method Changes in following parameters six months after the start of intervention.<br>1. Body data, 2. Blood data, 3. Mood symptoms, 4. Self-efficacy, 5. QOL, 6. intestinal flora, 7. content of fat and carbohydrate in feces, 8. frequency of stool and fecal characteristics, 9. dietary intake and 10. medication adherence.