Multimodal Phenotyping in Adolescent Inpatient Depression: An Observational Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-20
SponsorJiangsu Province Nanjing Brain Hospital
About this trial
This cohort study involves the dynamic collection of clinical information from adolescent patients with major depressive episodes (including both major depressive disorder and bipolar disorder), encompassing serum parameters, physiological-behavioral signals, neuroimaging data, and neuropsychological scales. The study aims to summarize the comprehensive clinical characteristics of this population, identify new risk factors, and establish multivariate predictive models for treatment response, cognitive and emotional impairments. Furthermore, this research will thoroughly investigate the underlying neural mechanisms linking clinical manifestations and neuroimaging features in major depressive episodes.
Eligibility criteria
Qualifiers
Between 10 and 20 years of age;
Diagnosis of major depressive disorder (MDD) or bipolar disorder (BD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Diagnosis is assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) for participants aged ≥18 years, or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) for participants aged <18 years;
Current moderate to severe depressive episode, defined as Hamilton Depression Rating Scale (HAMD) score ≥17;
Participants and 1 or 2 parents (patients' age< 18 years old) provide informed consent after the detailed description of the study.
Disqualifiers
Prior treatment with repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), electroconvulsive therapy (ECT), or standard psychological therapy within 6 months prior to screening;
Comorbidity with other DSM-IV Axis I disorders or personality disorders;
Judged clinically to be at serious risk of suicide;
Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;
Trial design
Treatments tested in this trial
- data collection and follow-up
Treatment groups
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov