Tests antidepressant options in teens whose first medicine did not help depression
Tests existing antidepressants in teens with depression who did not respond to first treatment.
Plain-language title generated from the registry record
Registry title: Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)
Key facts
- Where
- Chongqing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT07011693, who can take part
Where in China
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xinyu Zhou
- Trial code
- NCT07011693
- Record updated
- 10 June 2025
- Original description
This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.Read full original descriptionShow less
Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial
This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.
Inclusion: Aged 12-17; As assessed by K-SADS-PL, it meets the DSM-5 criteria for MDD; CDRS-R≥45; CGI-S≥4; 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: Received modified electroconvulsive therapy within 3 months; Current or lifetime diagnosis of bipolar disorder, schizophrenia, autism, attention-deficit/hyperactivity disorder or obsessive-compulsive disorder or psychosis not otherwise specified; Current or lifetime diagnosis of serious neurologic diseases such as epilepsy, brain trauma or other serious physical illnesses; 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); History of clear-cut intolerability of, or lack of effect with, an adequate trial of sertraline, agomelatine, or aripiprazole; MDD with psychotic symptoms; YMRS>13; Current depressive episode with clear suicidal plans or behaviors; Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment; Substance abuse or dependence; Female patients with pregnancy.