Phase
Condition
Depression
Mood Disorders
Depression (Adult And Geriatric)
Treatment
N/AClinical Study ID
Ages 14-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients diagnosed with Major Depressive Disorder as certified by a SCID 5 (Structured Clinical Interview for DSM-5) for DSM-S for adults and K-SADS-PL-DSM 5 (Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetimefor DSM 5) for adolescents.
Currently experiencing a major depressive episode with a HAM-D (Hamilton Depression)score of 18 or greater, or alternatively, a MADRS (Montgomery-Asberg DepressionRating Scale) score of 18 or greater.
About to start a new antidepressant.
Not concurrently starting a new psychotropic medication.
Age 14-50 years.
Able to use mobile devices (smart phone, tablet).
Willingness to provide written informed consent to participate.
Exclusion
Exclusion Criteria:
Intellectual disability.
Neurological disease (multiple sclerosis, severe neurocognitive disorder, epilepsy).
Current psychotic disorder or mood disorder with psychotic features.
Primary diagnosis of alcohol or substance use disorder (DSM-5).
Patients who started concomitant psychotropic medications less than one week ago.
Active, ongoing inflammatory diseases (such as rheumatoid arthritis and rheumaticpolymyalgia). or severe and unstable physical illness (such as recent myocardialinfarction).
A history of hepatitis B or C, human immunodeficiency virus, or evidence of activetuberculosis infection or any active systemic infection within 2 weeks prior to thestart of the study.
Use of antibiotics or other medications that may have affected the composition ofthe microbiota during the 30 days prior to baseline.
Pregnancy and lactation.
Study Design
Study Description
Connect with a study center
Università Degli Studi Di Siena
Siena, 53100
ItalyActive - Recruiting
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