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OpenTrials
Completed

NCT Number: NCT03660280

Probiotics to Treat "Inflammatory Depression"

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatry Clinic, Lund, Region Skåne

Lund, 22358, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Probiotics

Dietary Supplement

Specific probiotic lactobacilli (added to stabilized ongoing treatment)

Placebo

Other

Placebo

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale (interview version)

    Time frame: 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

  2. "Inflammatory depressive symptoms"

    Time frame: 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)

Secondary outcomes

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

    Time frame: 8 weeks

    Total Composite score indicate severity of gastrointestinal symtoms, ranging from 0-78

  2. Dimensional Anhedonia Rating Scale (DARS)

    Time frame: 8 weeks

    Total Composite score of 17 items, measuring different hedonic domains.

  3. WHO Disability Assessment Schedule (WHODAS)

    Time frame: 8 weeks

    Total Composite score of 36 items, measuring Health and disability within 6 different domains, ranging from 0-144.

  4. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 8 weeks

    Total Composite score of 7 items, measuring anxiety symtoms, ranging from 0-21.

  5. Insomnia Severity Index (ISI)

    Time frame: 8 weeks

    Total Composite score of 7 items, ranging from 0-28

  6. Fatigue Severity Scale (FSS)

    Time frame: 8 weeks

    Total Composite score of 9 items, measuring severity of fatigue, ranging from 1-63

  7. Wechsler Adult Intelligence Scale (WAIS-IV)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • BioGaia AB

Registry information

Official study title

Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2018
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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