DepressionNCT03660280
Probiotics to Treat "Inflammatory Depression"
A study testing Probiotics in people with Depression, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depression
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSweden
- Study dates
- 6 Nov 2018to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial
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
- Being tested
- Probiotics, Placebo
- Keywords
- Inflammation
- Medical subject headings
- Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Specific probiotic lactobacilli (added to stabilized ongoing treatment)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Not described Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 8 weeks
Secondary outcomes (7)
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS)
Total Composite score indicate severity of gastrointestinal symtoms, ranging from 0-78
Measured: 8 weeks
Dimensional Anhedonia Rating Scale (DARS)
Total Composite score of 17 items, measuring different hedonic domains.
Measured: 8 weeks
WHO Disability Assessment Schedule (WHODAS)
Total Composite score of 36 items, measuring Health and disability within 6 different domains, ranging from 0-144.
Measured: 8 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Total Composite score of 7 items, measuring anxiety symtoms, ranging from 0-21.
Measured: 8 weeks
Insomnia Severity Index (ISI)
Total Composite score of 7 items, ranging from 0-28
Measured: 8 weeks
Fatigue Severity Scale (FSS)
Total Composite score of 9 items, measuring severity of fatigue, ranging from 1-63
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start6 Nov 2018
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Daniel Lindqvist, Region Skane
- Investigators
- Daniel Lindqvist, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660280
- Sponsor's protocol ID
- 2018/379
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03660280
- Acronym / sponsor ID
- 2018/379
- Conditions
- Depression
- Keywords
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsSpecific probiotic lactobacilli (added to stabilized ongoing treatment) | Dietary supplement | Probiotics |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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
"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)
7 secondary outcomes
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS)
Time frame: 8 weeks
Dimensional Anhedonia Rating Scale (DARS)
Time frame: 8 weeks
WHO Disability Assessment Schedule (WHODAS)
Time frame: 8 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 8 weeks
Insomnia Severity Index (ISI)
Time frame: 8 weeks
Fatigue Severity Scale (FSS)
Time frame: 8 weeks
Wechsler Adult Intelligence Scale (WAIS-IV)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lindqvist, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Depression, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (interview version) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.