Overview

Sequenced Treatment in Adolescents With Major Depression (STAMD): a Multicenter Open-label Randomized Controlled Trial

Status:
Recruiting
Trial end date:
2027-07-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of this project is 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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital of Chongqing Medical University
Collaborator:
Second Xiangya Hospital of Central South University
Treatments:
Aripiprazole
Duloxetine Hydrochloride
Fluoxetine
Lithium Carbonate
Olanzapine
Sertraline
Vortioxetine
Criteria
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. Scoreā‰„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