Clinical trial NCT03660280: Probiotics to Treat "Inflammatory Depression"
Official title: Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Inflammation
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2018-09-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention will be add-on specific probiotic to ongoing treatment with antidepressant medication or Cognitive Behavioral Therapy (CBT). Subjects will be randomized to placebo or probiotic. To assure a balanced subject recruitment, block randomization within strata (ongoing treatment with CBT, antidepressant or both) will be performed. Blood sampling and symptom rating scales will be completed at baseline, at weeks 4 and 8 (end of study). Feces will be collected at baseline and end of study. Biomarkers (from baseline, week 4 and week 8) will be analyzed after the study. Subjects will be recruited from outpatient or inpatient settings, Psychiatry Skåne or primary care clinics in Skåne, Sweden. Subjects will be recruited via clinical referrals, but also via ads.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (interview version)
timeFrame: 8 weeks
measure: "Inflammatory depressive symptoms"
timeFrame: 8 weeks
Secondary outcomes:
measure: Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS)
timeFrame: 8 weeks
measure: Dimensional Anhedonia Rating Scale (DARS)
timeFrame: 8 weeks
measure: WHO Disability Assessment Schedule (WHODAS)
timeFrame: 8 weeks
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 8 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 8 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 8 weeks
measure: Wechsler Adult Intelligence Scale (WAIS-IV)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Psychiatry Clinic, Lund, Region Skåne
Study officials:
affiliation: Region Skane
name: Daniel Lindqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References: