Probiotics to Treat "Inflammatory Depression"

Region Skane

Status: Completed

Conditions: Depression

Treatments: Dietary Supplement: Probiotics; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03660280

2018/379

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Treatment:

Other: Placebo