Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Probiotic Supplementation in Severe Depression

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by Psychiatric Hospital of the University of Basel
Sponsor:
Information provided by (Responsible Party):
André Schmidt, Psychiatric Hospital of the University of Basel
ClinicalTrials.gov Identifier:
NCT02957591
First received: November 1, 2016
Last updated: November 3, 2016
Last verified: November 2016
  Purpose
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 Intervention
Severe Depression
Dietary Supplement: Vivomixx®
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Probiotic Supplementation on the Efficacy of Antidepressant Treatment in Depression

Further study details as provided by Psychiatric Hospital of the University of Basel:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Estimated Enrollment: 60
Study Start Date: January 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02957591

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

Locations
Switzerland
University Psychiatric Clinics (UPK) Not yet 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
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)
  More Information

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
Study First Received: November 1, 2016
Last Updated: November 3, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 24, 2017