This project aims to investigate the effectiveness of existing common antidepressants and to provide new evidence for depressed children and adolescents who are not responding to their first treatment.
This is an open-label Sequential Multiple Assignment Randomized Trial (SMART) of 16 weeks duration with two levels, each stage 8 weeks. In phase 1, adolescents with MDD will be selected into fluoxetine or fluoxetine combination CBT therapy groups and the choice of treatment will be at the discretion of the patient. Subjects who fail to respond will enter phase 2 randomization， where patients will be randomly assigned to oral sertraline, votioxetine, duloxetine or adding one of aripiprazole, lithium carbonate, and olanzapine to fluoxetine. The primary outcome of the treatment phase is the treatment remission rate and response rate. Secondary outcomes included: symptom scale; Quality of life; Sleep therapy; Symptoms of anxiety; Rumination and safety assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
520
Commonly used oral antidepressant.
Commonly used oral antidepressant.
Commonly used oral antidepressant.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Province, China
RECRUITINGChange in CDRS-R (Children's Depression Rating Scale) scores from baseline
Clinical response (≥ 50% reduction in CDRS-R scores from baseline)
Time frame: Baseline of treatment period, 2 weeks, 1 month, 2 months, 3 months，4months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Change in BDI-II (Baker Depression Scale) scores from baseline
Change in BDI-II (Baker Depression Scale) scores from baseline
Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
Improvement in anxiety (SCARED minus the scores）
Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
The severity of the suicide risk
Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
Improvement in sleep status (PSQI minus the scores）
Time frame: Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline
Improvement of children's quality of life（PedsQL4.0 minus the scores)
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Commonly used oral antidepressant.
Commonly used oral augmentation therapy for antidepressants
Commonly used oral augmentation therapy for antidepressants.
Commonly used oral augmentation therapy for antidepressants.
Commonly used intervention therapy of psychotherapy.
Time frame: Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
Improvement in overall clinical impression severity（ 7-point scale, with 1 being normal and 7 being among the most severely damaged）
Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months.
Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
Improvement of clinical general Impression scale（ 7-point scale,7 denoting a very significant deterioration）
Time frame: The treatment period was 1 month, 2 months, 3 months，4 months.
Change in RSS (Ruminative Responses Scale)
The level of improvement in negative thinking（he higher the total score, the more reflective thinking The more severe it is）
Time frame: The treatment period was 1 month, 2 months.
Change in HCL-32（Hypomania Symptom Checklist-32）
Assess the patient's hypomanic state
Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months