F32
Conditions
Interventions
Group 1: Synbiotics-group: Participants with inflammatory depression will receive an 8-week synbiotic intervention. Three capsules are taken per day. After a screening visit, the following parameters
blood samples
stool samples
and computer tasks assessing motivational behavior.
Group 2: Placebo-group: Participants with inflammatory depression will receive an 8-week placebo intervention. Three capsules are taken per day. Af
and computer tasks assessing motivational behavior.
Group 3: Control group: Healthy participants who do not receive any intervention undergo only the screening and the first day of testing (T1). The s
Sponsors
Goethe Universität Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Ability to give consent - BMI between 18-40 kg/m² - Willing and able to adhere to the provided diet on the days prior to testing - A score of 10 or higher on the Hamilton Depression Rating Scale - Exclusively for subjects with depression: o Inflammation: CRP of > 1mg/L o Presence of at least two out of the four following symptom categories: a) anhedonia b) increased appetite or weight c) increased sleep d) fatigue or leaden paralysis o Presence of a depressive episode, both first episode or an episode in the context of a known recurrent depressive disorder without psychotic symptoms o Need to be on stable medication for at least 4 weeks or not taking any medication for at least half a year prior to study start. A change in dosage of medication requires a 2-week waiting period prior to participation.
Exclusion criteria
Exclusion criteria: - History of one of the following psychiatric diagnoses (dementia, bipolar disorder, schizophrenic psychosis, substance abuse disorder) - History of neurological, neoplastic, and severe dermatological disorders - Clearly organic or substance-induced cause of depression - Pregnant or nursing - Acute infection (inclusion possible after a period of 2 weeks without symptoms) - Antibiotic treatment in the past month - Autoimmune disease requiring medication, at the exception of well-controlled Hasimoto’s - Intake of pre- pro- or synbiotics in the past 6 months - New vitamin or other supplementation in the past 3 months (vitamin or supplement intake longer than 3 months is permitted) - Exclusively for healthy control subjects: o Any current or lifetime psychiatric disorder according to ICD-10 criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in atypical depressive symptoms, as measured by the SIGH-ADS (Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement). This endpoint is assessed before the intervention, weekly during the intervention, and after the intervention (after 8 weeks), as well as at a follow-up time point 12 weeks after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in levels of SCFAs (short-chain fatty acids) in plasma and fecal samples and pro-inflammatory proteins (IL-17A, IL-6, TNF-alpha) in plasma between depressed individuals and healthy controls, measured at baseline. Change of anhedonia symptoms as measured with the SHAPS-D (Snaith-Hamilton Pleasure Scale) and of quality of life as measured with the EQ-5D-5L (European Quality of Life Questionnaire 5 dimensions). Change in plasma concentrations of key cytokines (IL-17A, IL-6, TNF-alpha). These endpoints are assessed before the intervention, after the intervention (after 8 weeks), as well as at follow-up (12 weeks after baseline). | — |
Countries
Germany
Contacts
Public ContactCarmen Schiweck
Goethe Universität Frankfurt
Outcome results
None listed