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

Depression Clinical Trial

— STAR-AD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814640
• Other study ID #: 1stChongqingMU--ZXY
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 20, 2023
• Est. completion date: July 1, 2027

Study information

• Verified date: August 2023
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Xinyu Zhou
• Phone: 15823996993
• Email: zhouxinyu[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: July 1, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Fluoxetine
Commonly used oral antipsychotics intervention therapy.
• Sertraline
Commonly used oral antipsychotics intervention therapy.
• Vortioxetine
Commonly used oral antipsychotics intervention therapy.
• Duloxetine
Commonly used oral antipsychotics intervention therapy.
• Aripiprazole
Commonly used oral antipsychotics intervention therapy.
• Lithium Carbonate
Commonly used oral antipsychotics intervention therapy.
• Olanzapine
Commonly used oral antipsychotics intervention therapy.

Behavioral:
• GCBT
Commonly used intervention therapy of psychotherapy.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Province

Sponsors (5)

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

Country where clinical trial is conducted

China, 

References & Publications (58)

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* Note: There are 58 references in all — Click here to view all references

Outcome

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

External Links

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