This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.
This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment. Adolescents ages 12 to 17, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) at least 8 weeks and still experiencing depression, participate in a 8-week randomized treatment study that includes one of three conditions: (1) switching to sertraline , (2) switching to duloxetine , (3) augmentation of their original SSRI with aripiprazole.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
Commonly used oral antipsychotics intervention therapy.
Commonly used oral antipsychotics intervention therapy.
Commonly used oral antipsychotics intervention therapy.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
response rate of Children's Depression Rating Scale (CDRS-R) scores
The primary outcomes are the treatment response rate (reduction rate of CDRS-R≥50%). The CDRS-R is a scale consisting of 17 items that are evaluated by clinicians to assess the intensity of depressive symptoms in adolescents, with items scored on scales of 1 to 5 or 1 to 7, resulting in a possible total score range of 17 to 113,higher scores mean a worse outcome.
Time frame: Baseline of treatment period, 4 weeks, 8 weeks
Change in Baker Depression Scale(BDI-II) scores from baseline
Change in BDI-II scores from baseline,The BDI is a self-report rating scale containing 21 items. Based on the BDI scores, depression can be classified into six levels: normal (1-10), mild mood disorder (11-16), borderline clinical depression (17-20), moderate depression (21-30), severe depression (31-40), and extreme depression (over 40).Higher scores mean a worse outcome.
Time frame: Baseline of treatment period, 4 weeks, 8 weeks
Change in The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scores from baseline
The SCARED is employed to evaluate child anxiety symptoms. Each question is rated from 0 to 2, with 0 denoting "not true or hardly ever true," 1 denoting "somewhat true or sometimes true", and 2 denoting "extremely true or often true". The maximum total score is 63. Higher scores mean a better or worse outcome.
Time frame: Baseline of treatment period, 4 weeks,8 weeks
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, 4 weeks, 8 weeks,
Adverse Event (AE) or Serious Adverse Event (SAE)
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Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale), Adverse Event (AE) or Serious Adverse Event (SAE)
Time frame: Baseline of treatment period, 1 month, 2 months,