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Probiotic Supplementation in Severe Depression

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ClinicalTrials.gov Identifier: NCT02957591
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
André Schmidt, Psychiatric Hospital of the University of Basel

Brief Summary:
Recent research demonstrates that the composition of the gut microbiome is a master regulator of key neurophysiological processes that are affected in depression. Indeed, contemporary studies showed that faecal microbiota is altered in patients with major depressive disorder (MDD). Furthermore, it has also been shown that supplementation of probiotics ameliorated depressive symptoms in unmedicated patients with mild to moderate depression. However, no study has yet explored the efficacy of a probiotic-based therapy in patients with severe MDD in addition to a standard antidepressant treatment. As dietary and lifestyle interventions may be a desirable, effective, pragmatical and non-stigmatizing prevention and adjuvant therapy (in addition to antidepressant treatment) in depression, this project is aimed at investigating for the first time if probiotic supplementation compared to a placebo treatment improves the effect of standard antidepressant medication on depressive symptoms (i.e. better and faster remission) in patients with severe MDD. Furthermore, this study will further test if probiotic supplementation modulates immune signalling and inflammatory processes (macrophage migration inhibitory factor and interleukin 1 beta), hypothalamic-pituitaryadrenal (HPA) axis responses (saliva cortisol), neurogenesis (brain-derived neurotrophic factor (BDNF) expression), the release of appetite-regulating hormones (leptin and ghrelin), the composition of gut microbiota (in particular levels of Enterobacteriaceae, Alistipes and Faecalibacterium) and brain perfusion, structure and activation and if these changes are associated with the probiotic-induced effect on depressive symptoms.

Condition or disease Intervention/treatment Phase
Severe Depression Dietary Supplement: Vivomixx® Other: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Probiotic Supplementation on the Efficacy of Antidepressant Treatment in Depression
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic Group
Over a period of 4 weeks, depressive patients will ingest a probiotic food supplementation (Vivomixx®) 4 times a day. Primary and secondary endpoints will be assessed before and after the intervention.
Dietary Supplement: Vivomixx®
Food supplementation with Vivomixx®. Vivomixx® (Mendes SA, Lugano, Switzerland) is a probiotic mixture of 8 strains: Streptococcus thermophiles DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) lactobacilli (L. acidophilus DSM 24735, L. plantarum DSM 24730, L. paracasei DSM 24733, L. delbrueckii subsp. Bulgaricus DSM 24734).

Placebo Comparator: Placebo Group
Subjects in the placebo group will receive a placebo 4 times a day over 4 weeks. Primary and secondary endpoints will be assessed before and after the intervention.
Other: Placebo
Subjects in the placebo group will receive a placebo that contains starch but no bacteria. The appearance of the placebo will be indistinguishable in color, shape, size, packaging, smell, and taste from that of the probiotic supplement.




Primary Outcome Measures :
  1. Hamilton Depression Score [ Time Frame: Change from baseline at week four ]

Secondary Outcome Measures :
  1. Brain perfusion [ Time Frame: Change from baseline at week four ]
    measured with arterial spin labeling (ASL)

  2. Brain structure [ Time Frame: Change from baseline at week four ]
    measured with diffusion tensor Imaging (DTI)

  3. Brain activation [ Time Frame: Change from baseline at week four ]
    measured with functional magnetic resonance imaging (fMRI)

  4. HPA axis function [ Time Frame: Change from baseline at week four ]
    measured with salivary cortisol awakening responses

  5. Neurogenesis [ Time Frame: Change from baseline at week four ]
    measured with blood levels of BDNF

  6. Appetite-regulating hormones [ Time Frame: Change from baseline at week four ]
    measured with blood levels of ghrelin and leptin

  7. Immunoregulation and inflammation [ Time Frame: Change from baseline at week four ]
    measured with blood levels of macrophage migration inhibitory factor and interleukin 1 beta

  8. Beck depression score [ Time Frame: Change from baseline at week four ]
  9. Psychopathology [ Time Frame: Change from baseline at week four ]
    measured with the Brief Symptom Check List (BSCL)

  10. Cognition [ Time Frame: Change from baseline at week four ]
    measured with the Trail Making Test A and B

  11. State and trait anxiety [ Time Frame: Change from baseline at week four ]
    measured wit the State-Trait Anxiety Inventory (STAI)

  12. Social interactions [ Time Frame: Change from baseline at week four ]
    measured with the Reading the Mind in the Eyes task

  13. Physical activity [ Time Frame: Change from baseline at week four ]
    measured with the International physical activity questionnaire (IPAQ) and Fitbit-Flex®, a portable wristwatch

  14. Sleep quality [ Time Frame: Change from baseline at week four ]
    measured with 3-channel electroencephalography (EEG) and the Insomnia Severity Index

  15. Gut microbiota composition [ Time Frame: Change from baseline at week four ]
    via faecal sampling

  16. Gastrointestinal side effects [ Time Frame: Change from baseline at week four ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18.
  • Severe MDD (Hamilton Depression Rating Scale (HAM-D) > 24).
  • Inpatient with antidepressant treatment at the UPK Basel (wards: P1, P2, J, B, VTS, S2, KIS).
  • Treated either with venlafaxine (Effexor), selective serotonin reuptake inhibitors, quetiapine (Seroquel) or benzodiazepines.

Exclusion Criteria:

  • Comorbid psychiatric disturbances such as substance abuse disorder, bipolar disorder, schizophrenia.
  • Current medical conditions such as acute infectious disease, dietary restrictions.
  • Immunosuppressed patients
  • Pregnancy, breast-feeding.
  • Inability to read and understand the participant's information.

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): NCT02957591


Contacts
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Contact: Undine Lang, Professor +41 61 325 5202 undine.lang@upkbs.ch

Locations
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Switzerland
University Psychiatric Clinics (UPK) Recruiting
Basel, Switzerland, 4012
Contact: Undine E Lang, Professor    +41 61 325 5202    undine.lang@upkbs.ch   
Principal Investigator: André Schmidt, Ph.D         
Principal Investigator: Laura Mählmann, M.Sc.         
Principal Investigator: Stefan Borgwardt, Professor         
Sub-Investigator: Serge Brand, Ph.D.         
Sub-Investigator: Christoph Beglinger, Professor         
Sponsors and Collaborators
Psychiatric Hospital of the University of Basel
Investigators
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Principal Investigator: André Schmidt, Ph.D. University Psychiatric Clinics (UPK)
Principal Investigator: Laura Mählmann, M.Sc. University Psychiatric Clinics (UPK)
Principal Investigator: Stefan Borgwardt, Professor University Psychiatric Clinics (UPK)

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Responsible Party: André Schmidt, Ph.D., Psychiatric Hospital of the University of Basel
ClinicalTrials.gov Identifier: NCT02957591     History of Changes
Other Study ID Numbers: 2016-01608
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 André Schmidt, Psychiatric Hospital of the University of Basel:
Depression
probiotic supplementation
Adjuvant Therapy
Gut microbiome
Psychological functioning
Brain imaging
Brain-Gut interactions
Sleep
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders