Probiotics to Treat "Inflammatory Depression"

NCT03660280 | Completed DMC

• 1 other identifier: 2018/379
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Inflammation

Outcome Measures

Primary Outcomes (2)

• Montgomery-Åsberg Depression Rating Scale (interview version)

  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

  8 weeks

• "Inflammatory depressive symptoms"

  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)

  8 weeks

Secondary Outcomes (7)

• Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS)

  8 weeks

• Dimensional Anhedonia Rating Scale (DARS)

  8 weeks

• WHO Disability Assessment Schedule (WHODAS)

  8 weeks

• Generalized Anxiety Disorder-7 (GAD-7)

  8 weeks

• Insomnia Severity Index (ISI)

  8 weeks

Study Arms (2)

Probiotics

EXPERIMENTAL

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Specific probiotic lactobacilli (added to stabilized ongoing treatment)

Probiotics

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Serious or unstable medical illness that in the investigator's opinion could compromise response to treatment or interpretation of study results.
• Known or suspected allergy to the study compounds.
• Ongoing infection.
• 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.
• Ongoing ECT.
• Patients who, in the investigator's judgment, pose a current, serious suicidal.
• A diagnosis for any Substance Use Disorder (except nicotine or caffeine) in the 3 months prior to the screening visit.
• 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).
• Antibiotic treatment/consumption within four (4) weeks before baseline visit.
• Patients who have taken foods or supplements with Probiotics later than two (2) weeks before baseline visit.
• Active participation in other clinical studies with ongoing study visits.
• Pregnancy.

Sponsors & Collaborators

• Region Skane: lead
• BioGaia AB: collaborator

Study Sites (1)

Psychiatry Clinic, Lund, Region Skåne

Lund, 22358, Sweden

Location

MeSH Terms

Conditions

Depression; Inflammation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Daniel Lindqvist, PhD

  Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Ass Prof

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: November 6, 2018
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

SE (1)