Back to resultsSequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) (STAR-AD)
Primary Purpose
Depression, Sequestra
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fluoxetine
Sertraline
Vortioxetine
Duloxetine
Aripiprazole
Lithium Carbonate
Olanzapine
GCBT
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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 ) 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
Sites / Locations
- The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Fluoxetine
group cognitive behavioral therapy（GCBT）
Sertraline
Votioxetine
Duloxetine
Aripiprazole
Lithium carbonate
Olanzapine
Arm Description
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.
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.
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
Clinical response (≥ 50% reduction in CDRS-R scores from baseline)
Secondary Outcome Measures
Change in BDI-II (Baker Depression Scale) scores from baseline
Change in BDI-II (Baker Depression Scale) scores from baseline
Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
Improvement in anxiety (SCARED minus the scores）
Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
The severity of the suicide risk
Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
Improvement in sleep status (PSQI minus the scores）
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)
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）
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）
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）
Change in HCL-32（Hypomania Symptom Checklist-32）
Assess the patient's hypomanic state
Full Information
NCT ID
NCT05814640
First Posted
April 4, 2023
Last Updated
August 9, 2023
Sponsor
First Affiliated Hospital of Chongqing Medical University
Collaborators
The Second Affiliated Hospital of Chongqing Medical University, Children's Hospital of Chongqing Medical University, Southwest Hospital, China, Central South University
1. Study Identification
Unique Protocol Identification Number
NCT05814640
Brief Title
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
Acronym
STAR-AD
Official Title
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Chongqing Medical University
Collaborators
The Second Affiliated Hospital of Chongqing Medical University, Children's Hospital of Chongqing Medical University, Southwest Hospital, China, Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Sequestra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluoxetine
Arm Type
Experimental
Arm Description
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.
Arm Title
group cognitive behavioral therapy（GCBT）
Arm Type
Experimental
Arm 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.
Arm Title
Sertraline
Arm Type
Experimental
Arm 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.
Arm Title
Votioxetine
Arm Type
Experimental
Arm 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.
Arm Title
Duloxetine
Arm Type
Experimental
Arm 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.
Arm Title
Aripiprazole
Arm Type
Experimental
Arm 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.
Arm Title
Lithium carbonate
Arm Type
Experimental
Arm Description
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.
Arm Title
Olanzapine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Commonly used oral antipsychotics intervention therapy.
Intervention Type
Behavioral
Intervention Name(s)
GCBT
Intervention Description
Commonly used intervention therapy of psychotherapy.
Primary Outcome Measure Information:
Title
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
Description
Clinical response (≥ 50% reduction in CDRS-R scores from baseline)
Time Frame
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 Outcome Measure Information:
Title
Change in BDI-II (Baker Depression Scale) scores from baseline
Description
Change in BDI-II (Baker Depression Scale) scores from baseline
Time Frame
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
Title
Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline
Description
Improvement in anxiety (SCARED minus the scores）
Time Frame
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
Title
Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)
Description
The severity of the suicide risk
Time Frame
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
Title
Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline
Description
Improvement in sleep status (PSQI minus the scores）
Time Frame
Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Title
Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline
Description
Improvement of children's quality of life（PedsQL4.0 minus the scores)
Time Frame
Baseline of treatment period, 2 month, 4 months; The follow-up period was 1 month, 3 months, 6 months and 12 months
Title
Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
Description
Improvement in overall clinical impression severity（ 7-point scale, with 1 being normal and 7 being among the most severely damaged）
Time Frame
Baseline of treatment period, 1 month, 2 months, 3 months，4 months.
Title
Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
Description
Improvement of clinical general Impression scale（ 7-point scale,7 denoting a very significant deterioration）
Time Frame
The treatment period was 1 month, 2 months, 3 months，4 months.
Title
Change in RSS (Ruminative Responses Scale)
Description
The level of improvement in negative thinking（he higher the total score, the more reflective thinking The more severe it is）
Time Frame
The treatment period was 1 month, 2 months.
Title
Change in HCL-32（Hypomania Symptom Checklist-32）
Description
Assess the patient's hypomanic state
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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 )
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinyu Zhou
Phone
15823996993
Email
zhouxinyu@cqmu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Province
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Xinyu, Doctor of Philosophy
Phone
15823996993
Email
zhouxinyu@cqmu.edu.cn
12. IPD Sharing Statement
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Links:
URL
http://apps.who.int/iris/handle/10665/254610
Description
Depression and Other Common Mental Disorders Global Health Estimates
URL
https://www.nice.org.uk/guidance/ng222
Description
Depression in adults: recognition and management
URL
https://www.menet.com.cn/
Description
Review and opportunity analysis of antidepressant drug market in China
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Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
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