Clinical trial NCT05814640: Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
Official title: Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Depression
Sequestra
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Chongqing Medical University
name: Children's Hospital of Chongqing Medical University
name: Southwest Hospital, China
name: Central South University
First posted: 2023-04-18
Enrollment: 520
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: After receiving fluoxetine and fluoxetine combined with cognitive-behavioral therapy, the next stage of treatment is determined by the patient's response (remission and non-remission) and is scheduled according to the patient's wishes and random assignment.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
timeFrame: 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 outcomes:
measure: Change in BDI-II (Baker Depression Scale) scores from baseline
timeFrame: 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
measure: Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
timeFrame: 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
measure: Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
timeFrame: 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
measure: Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
timeFrame: Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
measure: Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline
timeFrame: Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
measure: Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
timeFrame: Baseline of treatment period, 1 month, 2 months, 3 months，4 months.
measure: Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
timeFrame: The treatment period was 1 month, 2 months, 3 months，4 months.
measure: Change in RSS (Ruminative Responses Scale)
timeFrame: The treatment period was 1 month, 2 months.
measure: Change in HCL-32（Hypomania Symptom Checklist-32）
timeFrame: 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
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Province
Study officials:
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