RecruitingPhase 1Phase 2NCT05814640

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

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


Sponsor

First Affiliated Hospital of Chongqing Medical University

Enrollment

520 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 13 YearsMax Age: 18 Years

Inclusion Criteria6

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

Exclusion Criteria12

  • History of bipolar disorder, schizophrenia, autism, eating disorders, primary obsessive compulsive disorder, pervasive developmental disorder, or psychosis not otherwise specified
  • History of serious physical illnesses
  • Substance abuse or dependence
  • Current depressive episode with clear suicidal plans or suicidal behavior
  • Requires inpatient treatment for psychiatric disorders
  • Severe mental disorders requiring
  • 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 )
  • History of clear-cut intolerability of, or lack of effect with, an adequate trial of at least one protocol treatment option
  • Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment
  • Taking or administering antidepressants within 5 half-lives
  • Received modified electroconvulsive therapy within 12 months
  • If female, is pregnant

Interventions

DRUGFluoxetine

Commonly used oral antidepressant.

DRUGSertraline

Commonly used oral antidepressant.

DRUGVortioxetine

Commonly used oral antidepressant.

DRUGDuloxetine

Commonly used oral antidepressant.

DRUGAripiprazole

Commonly used oral augmentation therapy for antidepressants

DRUGLithium Carbonate

Commonly used oral augmentation therapy for antidepressants.

DRUGOlanzapine

Commonly used oral augmentation therapy for antidepressants.

BEHAVIORALGCBT

Commonly used intervention therapy of psychotherapy.


Locations(1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Province, China

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NCT05814640


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