Investigating treatment options for adolescent depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the effectiveness of common antidepressants in treating adolescents with Major Depressive Disorder (MDD) who have not responded to initial treatments. It employs a Sequential Multiple Assignment Randomized Trial (SMART) design over 16 weeks, divided into two phases. In phase 1, participants will choose between fluoxetine or fluoxetine combined with cognitive behavioral therapy (CBT). Those who do not respond will be randomized in phase 2 to receive alternative medications or combinations to assess treatment remission and response rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 13 - 18
2. As assessed by K-SADS-PL, it meets the DSM-V criteria for MDD with non-psychotic symptoms
3. Score≥40 on the CDRS-R
4. Participants with suicidal ideation are eligible, as long as clinicians consider outpatient treatment to be safe
5. Sufficient audio-visual level to complete this study
6. Written informed consent was obtained from patients and at least one of their parents

Exclusion Criteria:

1. History of bipolar disorder, schizophrenia, autism, eating disorders, primary obsessive compulsive disorder, pervasive developmental disorder, or psychosis not otherwise specified
2. History of serious physical illnesses
3. Substance abuse or dependence
4. Current depressive episode with clear suicidal plans or suicidal behavior
5. Requires inpatient treatment for psychiatric disorders
6. Severe mental disorders requiring
7. 2 or more failed trials of antidepressant drugs: each trial for at least 8 weeks, with the last 4 weeks at full dose (e.g. fluoxetine 40mg/d, citalopram 40mg/d, escitalopram 20mg/d, sertraline 150mg/d )
8. History of clear-cut intolerability of, or lack of effect with, an adequate trial of at least one protocol treatment option
9. Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment
10. Taking or administering antidepressants within 5 half-lives
11. Received modified electroconvulsive therapy within 12 months
12. If female, is pregnant

Where it's running

• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, Province, China Recruiting

Study contacts

• Study coordinator: Xinyu Zhou
• Email: zhouxinyu@cqmu.edu.cn
• Phone: 15823996993

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.