Clinical trial NCT07011693: Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)
Official title: Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Major Depressive Disorder (MDD)
Keywords: adolescent
SSRI
depression
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 12-17;
2. As assessed by K-SADS-PL, it meets the DSM-5 criteria for MDD;
3. CDRS-R≥45;
4. CGI-S≥4;
5. Failed to respond to an initial SSRI trial: the trial at least 8 weeks, with the last of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent.

Exclusion Criteria:

1. Current or lifetime diagnosis of bipolar disorder, schizophrenia, autism, attention-deficit/hyperactivity disorder or obsessive-compulsive disorder or psychosis not otherwise specified;
2. MDD with psychotic symptoms;
3. YMRS\>13;
4. Current or lifetime diagnosis of serious neurologic diseases such as epilepsy, brain trauma or other serious physical illnesses;
5. Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (at least 8 weeks, with the last 4 of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent);
6. History of clear-cut intolerability of, or lack of effect with, an adequate trial of sertraline, agomelatine, or aripiprazole;
7. Current depressive episode with clear suicidal plans or behaviors;
8. Received modified electroconvulsive therapy within 3 months;
9. Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment;
10. Substance abuse or dependence;
11. Female patients with pregnancy.

Primary outcomes:
measure: response rate of Children's Depression Rating Scale (CDRS-R) scores
timeFrame: Baseline of treatment period, 4 weeks, 8 weeks
Secondary outcomes:
measure: Change in Baker Depression Scale（BDI-II) scores from baseline
timeFrame: Baseline of treatment period, 4 weeks, 8 weeks
measure: Change in The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scores from baseline
timeFrame: Baseline of treatment period, 4 weeks，8 weeks
measure: Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
timeFrame: Baseline of treatment period, 4 weeks, 8 weeks,
measure: Adverse Event (AE) or Serious Adverse Event (SAE)
timeFrame: Baseline of treatment period, 1 month, 2 months,
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: