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NCT Number: NCT05814640

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Sequestra

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Province, 400000, China

Location status: Recruiting

Location contact

Zhou Xinyu, Doctor of Philosophy

CONTACT

[email protected]

15823996993

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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
  • 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 )
  • 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

Treatment and study plan

Fluoxetine

Drug

Commonly used oral antidepressant.

Sertraline

Drug

Commonly used oral antidepressant.

Vortioxetine

Drug

Commonly used oral antidepressant.

Duloxetine

Drug

Commonly used oral antidepressant.

Aripiprazole

Drug

Commonly used oral augmentation therapy for antidepressants

Lithium Carbonate

Drug

Commonly used oral augmentation therapy for antidepressants.

Olanzapine

Drug

Commonly used oral augmentation therapy for antidepressants.

GCBT

Behavioral

Commonly used intervention therapy of psychotherapy.

Primary outcomes

  1. Change in CDRS-R (Children's Depression Rating Scale) scores from baseline

    Time frame: Baseline of treatment period, 2 weeks, 1 month, 2 months, 3 months，4months; The follow-up period was 1 month, 3 months, 6 months and 12 months

    Clinical response (≥ 50% reduction in CDRS-R scores from baseline)

Secondary outcomes

  1. Change in BDI-II (Baker Depression Scale) scores from baseline

    Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months

    Change in BDI-II (Baker Depression Scale) scores from baseline

  2. Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline

    Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months

    Improvement in anxiety (SCARED minus the scores）

  3. Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)

    Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months

    The severity of the suicide risk

  4. Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline

    Time frame: Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months

    Improvement in sleep status (PSQI minus the scores）

  5. Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline

    Time frame: Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months

    Improvement of children's quality of life（PedsQL4.0 minus the scores)

  6. Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline

    Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months.

    Improvement in overall clinical impression severity（ 7-point scale, with 1 being normal and 7 being among the most severely damaged）

  7. Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline

    Time frame: The treatment period was 1 month, 2 months, 3 months，4 months.

    Improvement of clinical general Impression scale（ 7-point scale,7 denoting a very significant deterioration）

  8. Change in RSS (Ruminative Responses Scale)

    Time frame: The treatment period was 1 month, 2 months.

    The level of improvement in negative thinking（he higher the total score, the more reflective thinking The more severe it is）

  9. Change in HCL-32（Hypomania Symptom Checklist-32）

    Time frame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months

    Assess the patient's hypomanic state

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyu Zhou

CONTACT

[email protected]

15823996993

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Collaborators

  • Children's Hospital of Chongqing Medical University
  • Second Xiangya Hospital of Central South University
  • The Second Affiliated Hospital of Chongqing Medical University

Registry information

Official study title

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

Acronym: STAR-AD

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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