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Probiotics to Treat "Inflammatory Depression"

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ClinicalTrials.gov Identifier: NCT03660280
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Daniel Lindqvist, 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.

Condition or disease Intervention/treatment Phase
Depression Dietary Supplement: Probiotics Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotics Dietary Supplement: Probiotics
Specific probiotic lactobacilli (added to stabilized ongoing treatment)

Placebo Comparator: Placebo Other: Placebo
Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660280


Contacts
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Contact: Daniel Lindqvist, PhD +4646173885 daniel.lindqvist@med.lu.se
Contact: Gustav Söderberg, MD

Locations
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Sweden
Psychiatry Clinic, Lund, Region Skåne Recruiting
Lund, Sweden, 22358
Contact: Daniel Lindqvist    733547441    daniel.lindqvist@med.lu.se   
Sponsors and Collaborators
Region Skane
BioGaia AB
Investigators
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Principal Investigator: Daniel Lindqvist, PhD Region Skane

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Responsible Party: Daniel Lindqvist, MD, PhD, Ass Prof, Region Skane
ClinicalTrials.gov Identifier: NCT03660280     History of Changes
Other Study ID Numbers: 2018/379
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Lindqvist, Region Skane:
Inflammation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders