Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)

Last updated: August 9, 2023
Sponsor: First Affiliated Hospital of Chongqing Medical University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Depression

Treatment

Sertraline

Lithium Carbonate

Fluoxetine

Clinical Study ID

NCT05814640
1stChongqingMU--ZXY
  • Ages 13-18
  • All Genders

Study Summary

This project aims to investigate the effectiveness of existing common antidepressants and to provide new evidence for depressed children and adolescents who are not responding to their first treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 13 - 18
  2. As assessed by K-SADS-PL, it meets the DSM-V criteria for MDD with non-psychoticsymptoms
  3. Score≥40 on the CDRS-R
  4. Participants with suicidal ideation are eligible, as long as clinicians consideroutpatient 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

Exclusion Criteria:

  1. History of bipolar disorder, schizophrenia, autism, eating disorders, primaryobsessive compulsive disorder, pervasive developmental disorder, or psychosis nototherwise 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, withthe 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 ofat least one protocol treatment option
  9. Taking any medicine that contraindicates in combination with or interferes with theefficacy 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

Study Design

Total Participants: 520
Treatment Group(s): 8
Primary Treatment: Sertraline
Phase: 1/2
Study Start date:
February 20, 2023
Estimated Completion Date:
July 01, 2027

Study Description

This is an open-label Sequential Multiple Assignment Randomized Trial (SMART) of 16 weeks duration with two levels, each stage 8 weeks. In phase 1, adolescents with MDD will be selected into fluoxetine or fluoxetine combination CBT therapy groups and the choice of treatment will be at the discretion of the patient. Subjects who fail to respond will enter phase 2 randomization， where patients will be randomly assigned to oral sertraline, votioxetine, duloxetine or adding one of aripiprazole, lithium carbonate, and olanzapine to fluoxetine. The primary outcome of the treatment phase is the treatment remission rate and response rate. Secondary outcomes included: symptom scale; Quality of life; Sleep therapy; Symptoms of anxiety; Rumination and safety assessment.

Connect with a study center

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Province 400000
    China

    Active - Recruiting

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