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

Phase 1

Recruiting

• Conditions: Sequestra; Depression
• Interventions: Behavioral: GCBT; Drug: Aripiprazole; Drug: Lithium Carbonate; Drug: Fluoxetine; Drug: Sertraline; Drug: Vortioxetine; Drug: Duloxetine; Drug: Olanzapine

• Registration Number: NCT05814640
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief 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.

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 pha...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-02-20
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14
• Primary Completion: 2025-12-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
group cognitive behavioral therapy（GCBT）	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.
Aripiprazole	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.
Lithium carbonate	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.
Fluoxetine	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.
Sertraline	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.
Votioxetine	Vortioxetine	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.
Duloxetine	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.
Olanzapine	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.

Primary Outcome Measures

Name	Time	Method
Change in CDRS-R (Children's Depression Rating Scale) 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	Clinical response (≥ 50% reduction in CDRS-R scores from baseline)

Secondary Outcome Measures

Name	Time	Method
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 BDI-II (Baker Depression Scale) scores from baseline
Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) 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	Improvement in anxiety (SCARED minus the scores）
Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline	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）
Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline	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）
Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline	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)
Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline	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）
Change in HCL-32（Hypomania Symptom Checklist-32）	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
Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)	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
Change in RSS (Ruminative Responses Scale)	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）

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Province, China