Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

The objective of this clinical trial is to evaluate the efficacy and safety of sertraline combined with multi-strain probiotics in adolescents aged 12-18 with major depressive disorder. The primary research question is whether sertraline combined with multi-strain probiotics is superior to sertraline combined with placebo in alleviating depressive symptoms and improving mood symptoms in adolescents. If there is a control group: researchers will compare sertraline combined with multi-strain probiotics with sertraline combined with placebo (a substance that looks similar but does not contain probiotics) to determine whether adding multi-strain probiotics provides greater therapeutic benefits for adolescent patients with depression. Participants will: 1. Undergo 8 weeks of treatment with sertraline combined with multi-strain probiotics or sertraline combined with placebo; 2. Have clinical visits every 4 weeks for clinical assessments and safety monitoring.

Eligibility criteria

Qualifiers

• Aged 12-18 years

Meets DSM-5 criteria for major depressive disorder (MDD) and is currently in a depressive episode according to the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) interviews

Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline

Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline

Disqualifiers

• Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders

MDD with psychotic symptoms

Young Mania Rating Scale (YMRS) >13 at baseline

History of neurological disorders (e.g., epilepsy, traumatic brain injury), or the presence of serious physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes mellitus, clinically significant pulmonary, hepatic, or renal impairment, or major trauma)

Trial design

Treatments tested in this trial

  • Sertraline

Treatment groups

120 Participants
are divided into 2 treatment groups