Probiotics to Treat "Inflammatory Depression"

Not Applicable

Completed

• Conditions: Depression
• Interventions: Dietary Supplement: Probiotics; Other: Placebo

• Registration Number: NCT03660280
• Lead Sponsor: Region Skane

Brief Summary

The main aims of this project are to test if: i) Specific probiotic lactobacilli (added to stabilized ongoing treatment) are efficacious in treating depressive symptoms in individuals with low-grade inflammation, defined using high sensitivity C-reactive protein (hs-CRP) and BMI. ii) This effect is mediated through decrease of inflammation, estimated by treatment-associated changes in blood and faeces biomarkers. Secondary aims are to investigate the relationship between specific depressive symptoms and inflammation and if there is a correlation between certain pro-inflammatory or metabolic markers and depression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Study Start: 2018-11-06
• Primary Completion: 2023-09-18
• Study Completion: 2023-09-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Age, 18-85
2. Depressive episode according to the DSM-V
3. MADRS-M score >18
4. All subjects will be stable on an antidepressant medication or in Cognitive Behavioural Therapy (CBT) for >4 weeks
5. Subjects will be willing not to significantly alter their diet during the period of the study
6. A hs-CRP value ≥1mg/L and BMI >25

Exclusion Criteria

1. Serious or unstable medical illness that in the investigator's opinion could compromise response to treatment or interpretation of study results.
2. Known or suspected allergy to the study compounds.
3. Ongoing infection.
4. A diagnosis of psychotic disorder, bipolar disorder, personality disorder mental retardation, dementia, or individual whom, due to other causes, lack the ability to make an informed decision.
5. Ongoing ECT.
6. Patients who, in the investigator's judgment, pose a current, serious suicidal.
7. A diagnosis for any Substance Use Disorder (except nicotine or caffeine) in the 3 months prior to the screening visit.
8. Any medications (within 1 week of baseline or during the trial) that might confound the biomarker findings, including: Regular ingestion of NSAIDs or COX-2 inhibitors, or any use of oral steroids, immunosuppressants, interferon, chemotherapy (Patients will be instructed not to take an NSAID, COX-2 inhibitor or Aspirin in the 24 hours prior to a biomarker assessment visit).
9. Antibiotic treatment/consumption within four (4) weeks before baseline visit.
10. Patients who have taken foods or supplements with Probiotics later than two (2) weeks before baseline visit.
11. Active participation in other clinical studies with ongoing study visits.
12. Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
"Inflammatory depressive symptoms"	8 weeks	Total composite score of the following items from the Patient Health Questionnaire (PHQ-9): item 3 (sleep problems), item 4 (lack of energy), and item 5 (appetite disturbance)
Montgomery-Åsberg Depression Rating Scale (interview version)	8 weeks	Decrease in depressive symtoms indicated by lower total score on mentioned scale, with 10 items, ranging from 0-60, a higher score indicating increased severity

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	8 weeks	Total Composite score of 7 items, ranging from 0-28
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS)	8 weeks	Total Composite score indicate severity of gastrointestinal symtoms, ranging from 0-78
Dimensional Anhedonia Rating Scale (DARS)	8 weeks	Total Composite score of 17 items, measuring different hedonic domains.
WHO Disability Assessment Schedule (WHODAS)	8 weeks	Total Composite score of 36 items, measuring Health and disability within 6 different domains, ranging from 0-144.
Generalized Anxiety Disorder-7 (GAD-7)	8 weeks	Total Composite score of 7 items, measuring anxiety symtoms, ranging from 0-21.
Fatigue Severity Scale (FSS)	8 weeks	Total Composite score of 9 items, measuring severity of fatigue, ranging from 1-63
Wechsler Adult Intelligence Scale (WAIS-IV)	8 weeks	Two Composite scores of two tests measuring cognitive functioning. Symbol search, ranging from 0-60 and Digit symbol coding test ranging from 0-135.

Trial Locations

Locations (1)

Psychiatry Clinic, Lund, Region Skåne; 🇸🇪 Lund, Sweden