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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1-sertraline | Experimental | dosage form: po dosage:25-200mg frequency:qd duration: patients will be given sertraline as a switching treatment to SSRI. |
|
| Group 2-agomelatine | Experimental | dosage form: po dosage:25-50mg frequency:qd duration: patients will be given agomelatine as a switching treatment to SSRI. |
|
| Group 3-aripiprazole with original SSRI | Experimental | dosage form: po dosage: 1.25-15mg frequency:qn duration: patientswill be given aripiprazole as an add-on treatment to original SSRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | Commonly used oral antipsychotics intervention therapy. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline of treatment period, 4 weeks, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyu Zhou | Contact | 2912-89012912 | zhouxinyu@cqmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| C084711 | agomelatine |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Agomelatine |
| Drug |
Commonly used oral antipsychotics intervention therapy. |
|
| Aripiprazole | Drug | Commonly used oral antipsychotics intervention therapy. |
|
| 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. | 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 | Baseline of treatment period, 4 weeks, 8 weeks, |
| Adverse Event (AE) or Serious Adverse Event (SAE) | Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale), Adverse Event (AE) or Serious Adverse Event (SAE) | Baseline of treatment period, 1 month, 2 months, |
| D001519 |
| Behavior |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |