Depression, Sequestra
Conditions
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.
Interventions
DRUGFluoxetine
Commonly used oral antidepressant.
DRUGSertraline
Commonly used oral antidepressant.
DRUGVortioxetine
Commonly used oral antidepressant.
DRUGDuloxetine
Commonly used oral antidepressant.
DRUGAripiprazole
Commonly used oral augmentation therapy for antidepressants
DRUGLithium Carbonate
Commonly used oral augmentation therapy for antidepressants.
DRUGOlanzapine
Commonly used oral augmentation therapy for antidepressants.
BEHAVIORALGCBT
Commonly used intervention therapy of psychotherapy.
Sponsors
First Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
Second Xiangya Hospital of Central South University
Children's Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes 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.
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CDRS-R (Children's Depression Rating Scale) 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 | Clinical response (≥ 50% reduction in CDRS-R scores from baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 BDI-II (Baker Depression Scale) scores from baseline |
| 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 | Improvement in anxiety (SCARED minus the scores） |
| 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 | The severity of the suicide risk |
| 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 | Improvement in sleep status (PSQI minus the scores） |
| 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 | Improvement of children's quality of life（PedsQL4.0 minus the scores) |
| Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline | Baseline of treatment period, 1 month, 2 months, 3 months，4 months. | 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 | The treatment period was 1 month, 2 months, 3 months，4 months. | Improvement of clinical general Impression scale（ 7-point scale,7 denoting a very significant deterioration） |
| Change in RSS (Ruminative Responses Scale) | The treatment period was 1 month, 2 months. | 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） | 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 | Assess the patient's hypomanic state |
Countries
China
Contacts
CONTACTXinyu Zhou
Outcome results
None listed