Skip to main content

Table 1 The inclusion and exclusion criteria

From: Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol

Inclusion criteria:

1. Age 13–18

2. As assessed by Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS-PL), it meets the DSM-5 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 behaviors

5. Requires inpatient treatment for psychiatric disorders

6. Patients with severe mental illness requiring immediate hospitalization

7. Two 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 40 mg/d, citalopram 40 mg/d, escitalopram 20 mg/d, sertraline 150 mg/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. Female patients with pregnancy