Investigating treatment options for adolescent depression

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD): a Pragmatic Clinical Trial

This study is testing different antidepressant options for teenagers with depression who haven't found relief from their first treatments to see which works best.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 520 (estimated)
• Ages: 13 Years to 18 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing, Province)
• Trial ID: NCT05814640 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 13 to 18 diagnosed with Major Depressive Disorder who have not adequately responded to initial antidepressant treatment.

Not a fit: Patients with a history of bipolar disorder, schizophrenia, or severe mental disorders requiring inpatient treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for adolescents suffering from depression who have not responded to first-line therapies.

How similar studies have performed: Other studies have shown promise in using sequential treatment approaches for depression, suggesting potential for success in this novel application.

Eligibility criteria

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 this trial is running

Chongqing, Province

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

Study contacts

• Study coordinator: Xinyu Zhou

Conditions Depression; Sequestra