Probiotics to Treat "Inflammatory Depression"

• Sponsor: Region Skane (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03660280
• Collaborator: BioGaia AB (Industry)
• Enrollment: 76
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48.8
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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.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: Nov 6, 2018
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotics	Dietary Supplement: Probiotics; Specific probiotic lactobacilli (added to stabilized ongoing treatment)
Placebo Comparator: Placebo	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Montgomery-Åsberg Depression Rating Scale (interview version) [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" [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) [8 weeks]

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

2. Dimensional Anhedonia Rating Scale (DARS) [8 weeks]

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

3. WHO Disability Assessment Schedule (WHODAS) [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) [8 weeks]

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

5. Insomnia Severity Index (ISI) [8 weeks]

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

6. Fatigue Severity Scale (FSS) [8 weeks]

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

7. Wechsler Adult Intelligence Scale (WAIS-IV) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatry Clinic, Lund, Region Skåne	Lund		Sweden	22358

Sponsors and Collaborators

• Region Skane
• BioGaia AB

Investigators

• Principal Investigator: Daniel Lindqvist, PhD, Region Skane

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Lindqvist, MD, PhD, Ass Prof, Region Skane
• ClinicalTrials.gov Identifier: NCT03660280
• Other Study ID Numbers: 2018/379
• First Posted: Sep 6, 2018
• Last Update Posted: Jan 5, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daniel Lindqvist, MD, PhD, Ass Prof, Region Skane: Inflammation
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Jan 5, 2022