Clinical Trials Logo
NCT number NCT03300440
Study type Interventional
Source Medical University of Graz
Contact Eva Reininghaus, PD, MD
Phone +43 316 385 80968
Status Recruiting
Phase N/A
Start date June 21, 2017
Completion date June 2019

Clinical Trial Summary

The aim of this study is to explore the effects of probiotics in individuals with a clinically relevant depression on psychiatric symptoms and cognition, inflammatory parameters, as well as gene-expression. The study is conducted as a placebo-controlled, randomized, double-blind, prospective, monocentric clinical study, with a two-arm parallel group design. Individuals in the intervention group receive the multispecies probiotics "Omnibiotics Stress Repair" in addition to vitamin B7, while individuals in the control group receive "Placebo" in addition to vitamin B7.

Clinical Trial Description

The study takes places at the Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine. Individuals that start inpatient treatment at the ward in the first floor of the Department because of a major depressive episode are eligible. After inclusion into the study, the participants are asked to fill in different self-rating questionnaires (Becks-Depression Inventory-II BDI-II, Symptom Checklist-90-Revised SCL-90-R, Manie-Selbstbeurteilungsskala german adaptation of Self-Report manic inventory (SRMI) - MSS, food frequency questionnaire). General data are explored routinely, as well as a diagnostic interview (MINI - mini international neuropsychiatric interview, German version 5.0) is performed during the stay at the hospital. Participants are asked to provide a stool probe as soon as possible.

At the day after admission, fasting blood is taken (100ml). Routine parameters are further analyzed at the local laboratory, while the rest is stored at -80 degree for later analyzes. Afterwards a cognitive test-battery is performed to measure verbal learning and memory, information processing speed, cognitive flexibility and working memory capacity.

After one week a further stool probe is taken, to measure possible changes in dietary habits due to the stay at the hospital. Antidepressive treatment at the hospital is continued as treatment as usual.

At the end participants go through a similar cognitive test battery as at the beginning and are asked to fill in the same self-rating questionnaires. If participants are discharged before day 28 they are given their own preparation and instructed to take it at home in the exact same manner. An outpatient appointment at the end of the preparation intake is arranged to collect the fasting blood and stool sample and to perform the cognitive assessment.

Study Design

Related Conditions & MeSH terms

See also
  Status Clinical Trial Phase
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran for Depression in Palliative Care Phase 2/Phase 3
Recruiting NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial N/A
Recruiting NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Enrolling by invitation NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Enrolling by invitation NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT02543983 - Neurobiology of Suicide Phase 2
Recruiting NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
Recruiting NCT00024635 - Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers N/A
Not yet recruiting NCT03473054 - Stroke Survivors and Caregivers Using an Online Mindfulness-based Intervention Together N/A
Not yet recruiting NCT03293797 - Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms N/A
Not yet recruiting NCT03196544 - Novel Behavioral Intervention to Enhance Social Connections in Anxiety and Depression N/A
Not yet recruiting NCT03254719 - Care Outcomes for Chiropractic Outpatient Veterans N/A
Recruiting NCT02911597 - Double-Blind, Cross-Over Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD) Phase 1
Recruiting NCT02987582 - A Feasibility Study of an Emotion-Focused Mindfulness Group N/A
Recruiting NCT02924090 - Hyperventilation Combined With Etomidate or Ketamine Anesthesia in ECT Treatment of Major Depression Phase 4
Recruiting NCT02970825 - Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being. N/A
Recruiting NCT02902159 - RCT of the Effectiveness of Big White Wall Compared to Other Online Support N/A
Recruiting NCT02777112 - The Effects of E-mental Health Program and Job Coaching on the Risk of Major Depression in Canadian Working Men N/A