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Clinical Trials in China / NCT07011693
Starting soon Phase 4

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression(SMART-I)

NCT07011693 · tracked via the Priya Life Science China tracker
Sponsor
Xinyu Zhou
Phase
Phase 4
Started
2025-06-20
Last updated
2025-06-10

Condition(s) studied

Major Depressive Disorder (MDD)

Investigational drug(s) / intervention(s)

SertralineAgomelatineAripiprazole

Sertraline: Commonly used oral antipsychotics intervention therapy.

Agomelatine: Commonly used oral antipsychotics intervention therapy.

Aripiprazole: Commonly used oral antipsychotics intervention therapy.

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality

On this site

📄 Zoloft (sertraline) drug profile → 📄 Abilify (aripiprazole) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07011693 on ClinicalTrials.gov ↗ ← All trials in China