Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
Recruiting · NCT05814640 · Interventional (participants receive a specific treatment) · Lead sponsor: First Affiliated Hospital of Chongqing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
Age range
13 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, Province, China