Probiotics to Treat "Inflammatory Depression"

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660280
• Other study ID #: 2018/379
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: September 18, 2023

Study information

• Verified date: November 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• Probiotics
Specific probiotic lactobacilli (added to stabilized ongoing treatment)

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Psychiatry Clinic, Lund, Region Skåne	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	BioGaia AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	"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	Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS)	Total Composite score indicate severity of gastrointestinal symtoms, ranging from 0-78	8 weeks
Secondary	Dimensional Anhedonia Rating Scale (DARS)	Total Composite score of 17 items, measuring different hedonic domains.	8 weeks
Secondary	WHO Disability Assessment Schedule (WHODAS)	Total Composite score of 36 items, measuring Health and disability within 6 different domains, ranging from 0-144.	8 weeks
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	Total Composite score of 7 items, measuring anxiety symtoms, ranging from 0-21.	8 weeks
Secondary	Insomnia Severity Index (ISI)	Total Composite score of 7 items, ranging from 0-28	8 weeks
Secondary	Fatigue Severity Scale (FSS)	Total Composite score of 9 items, measuring severity of fatigue, ranging from 1-63	8 weeks
Secondary	Wechsler Adult Intelligence Scale (WAIS-IV)	Two Composite scores of two tests measuring cognitive functioning. Symbol search, ranging from 0-60 and Digit symbol coding test ranging from 0-135.	8 weeks