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

Chongqing Medical University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Sequestra; Depression

Treatments: Drug: Duloxetine; Behavioral: GCBT; Drug: Lithium Carbonate; Drug: Aripiprazole; Drug: Vortioxetine; Drug: Fluoxetine; Drug: Sertraline; Drug: Olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT05814640

1stChongqingMU--ZXY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

520 participants in 8 patient groups

Fluoxetine

Experimental group

Description:

Dosage form: po Dosage: 10-60mg Frequency: qn Course of treatment: 8 weeks. At week 8, patients will be evaluated as "in " or "not in remission." "Patients who are not in remission" will be randomized to phase II treatment based on the patient's wishes.

Treatment:

Drug: Fluoxetine

group cognitive behavioral therapy（GCBT）

Experimental group

Description:

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.

Treatment:

Behavioral: GCBT

Sertraline

Experimental group

Description:

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.

Treatment:

Drug: Sertraline

Vortioxetine

Experimental group

Description:

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.

Treatment:

Drug: Vortioxetine

Duloxetine

Experimental group

Description:

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.

Treatment:

Drug: Duloxetine

Aripiprazole

Experimental group

Description:

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.

Treatment:

Drug: Aripiprazole

Lithium carbonate

Experimental group

Description:

dosage form: po dosage: 125-500mg frequency: qn duration: At Week 8, patients assessed as 'non-response' will be given lithium carbonate as an add-on treatment to fluoxetine.

Treatment:

Drug: Lithium Carbonate

Olanzapine

Experimental group

Description:

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.

Treatment:

Drug: Olanzapine