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NCT07011693Not yet recruitingPhase 4

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

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression(SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
400 (estimated)
First submitted
26 May 2025
Start date
20 Jun 2025
Primary completion date
Jun 2027
Lead sponsor
Xinyu Zhou
Diseases
Depression
NCT number
NCT07011693

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 400
  • From 20 Jun 2025 to the primary completion date, Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received modified electroconvulsive therapy within 3 months;

Other illness

  • 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;

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Chongqing Medical University
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.