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

NCT05814640 | Recruiting Phase 1 DMC

• 1 other identifier: 1stChongqingMU--ZXY
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Sequestra

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (9)

• 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

  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)

  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

  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

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

Study Arms (8)

Fluoxetine

EXPERIMENTAL

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.

Drug: Fluoxetine

group cognitive behavioral therapy（GCBT）

EXPERIMENTAL

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

Sertraline

EXPERIMENTAL

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

Vortioxetine

EXPERIMENTAL

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

Duloxetine

EXPERIMENTAL

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

Aripiprazole

EXPERIMENTAL

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

Lithium carbonate

EXPERIMENTAL

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.

Drug: Lithium Carbonate

Olanzapine

EXPERIMENTAL

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

Interventions

Fluoxetine DRUG

Commonly used oral antidepressant.

Fluoxetine

Sertraline DRUG

Commonly used oral antidepressant.

Sertraline

Vortioxetine DRUG

Commonly used oral antidepressant.

Vortioxetine

Duloxetine DRUG

Commonly used oral antidepressant.

Duloxetine

Aripiprazole DRUG

Commonly used oral augmentation therapy for antidepressants

Aripiprazole

Lithium Carbonate DRUG

Commonly used oral augmentation therapy for antidepressants.

Lithium carbonate

Olanzapine DRUG

Commonly used oral augmentation therapy for antidepressants.

Olanzapine

GCBT BEHAVIORAL

Commonly used intervention therapy of psychotherapy.

group cognitive behavioral therapy（GCBT）

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: collaborator
• First Affiliated Hospital of Chongqing Medical University: lead
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• Second Xiangya Hospital of Central South University: collaborator

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Province, 400000, China

RECRUITING

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• He Y, Gan X, Li X, Wang T, Li J, Lei T, Huang Y, Liu R, Chen F, Teng T, Xie Y, Ouyang X, Zhou X. Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol. BMC Psychiatry. 2023 Oct 27;23(1):789. doi: 10.1186/s12888-023-05221-w.

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Related Links

• Depression and Other Common Mental Disorders Global Health Estimates
• Depression in adults: recognition and management
• Review and opportunity analysis of antidepressant drug market in China

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine; Sertraline; Vortioxetine; Duloxetine Hydrochloride; Aripiprazole; Lithium Carbonate; Olanzapine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Benzodiazepines; Benzazepines

Central Study Contacts

Xinyu Zhou

CONTACT

15823996993; zhouxinyu@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the patient and the psychiatrist know which group they are allocated to, while the outcome assessor and data analyst are kept blind to the allocation. The clinicians providing the intervention do not perform the assessment and are unaware of the results.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: February 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)