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

August 9, 2023 updated by: Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Province
      • Chongqing, Province, China, 400000
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duloxetine
dosage form: po dosage: 60-120mg frequency: qn duration: At Week 8, patients assessed as 'non-remission' will be given duloxetine as an add-on treatment to fluoxetine.
Drug: Duloxetine
Commonly used oral antipsychotics intervention therapy.
Experimental: Lithium carbonate
dosage form:po dosage: 125-500mg frequency: qn duration: At Week 8, patients assessed as 'non-remission' will be given lithium carbonate as an add-on treatment to fluoxetine.
Drug: Lithium Carbonate
Commonly used oral antipsychotics intervention therapy.
Experimental: Olanzapine
dosage form:po dosage: 1.25-10mg frequency:qn duration: At Week 8, patients assessed as 'non-rremission' will be given olanzapine as an add-on treatment to fluoxetine.
Drug: Olanzapine
Commonly used oral antipsychotics intervention therapy.
Experimental: Fluoxetine
Dosage form: po Dosage: 10-60mg Frequency: qn Course of treatment: 8 weeks. At week 8, patients will be evaluated as "in remission" or "not in remission." "Patients who are not in remission" will be randomized to phase II treatment based on the patient's wishes.
Drug: Fluoxetine
Commonly used oral antipsychotics intervention therapy.
Experimental: group cognitive behavioral therapy（GCBT）
GCBT was administered in addition to fluoxetine and consisted of 11 sessions for 8 weeks. It lasts 90 to 120 minutes, once or twice a week. At week 8, patients will be evaluated as "in remission" or "not in remission." "Patients who are not in remission" will be randomized to phase II treatment based on the patient's wishes.
Behavioral: GCBT
Commonly used intervention therapy of psychotherapy.
Experimental: Sertraline
dosage form: po dosage:25-200mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given Sertraline as a switching treatment to fluoxetine.
Drug: Sertraline
Commonly used oral antipsychotics intervention therapy.
Experimental: Votioxetine
dosage form: po dosage: 10-20mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given votioxetine as a switching treatment to fluoxetine.
Drug: Vortioxetine
Commonly used oral antipsychotics intervention therapy.
Experimental: Aripiprazole
dosage form: po dosage: 2.5-15mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given aripiprazole as an add-on treatment to fluoxetine.
Drug: Aripiprazole
Commonly used oral antipsychotics intervention therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 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）
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 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
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 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）
Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
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)
Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
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
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 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）
Baseline of treatment period, 1 month, 2 months, 3 months，4 months.
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）
The treatment period was 1 month, 2 months, 3 months，4 months.
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）
The treatment period was 1 month, 2 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Collaborators

Southwest Hospital, China
Central South University
The Second Affiliated Hospital of Chongqing Medical University
Children's Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1stChongqingMU--ZXY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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