Health TrialsbyHealthPanel

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)

ConditionsDepressionSequestra
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age13-18
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Fluoxetine

    Drug

    Commonly used oral antidepressant.

  • Sertraline

    Drug

    Commonly used oral antidepressant.

  • Vortioxetine

    Drug

    Commonly used oral antidepressant.

  • Duloxetine

    Drug

    Commonly used oral antidepressant.

  • Aripiprazole

    Drug

    Commonly used oral augmentation therapy for antidepressants

  • Lithium Carbonate

    Drug

    Commonly used oral augmentation therapy for antidepressants.

  • Olanzapine

    Drug

    Commonly used oral augmentation therapy for antidepressants.

  • GCBT

    Behavioral

    Commonly used intervention therapy of psychotherapy.

Treatment groups

520 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: FluoxetineExperimental treatment 1 intervention
Group B: group cognitive behavioral therapy（GCBT）Experimental treatment 1 intervention
Group C: SertralineExperimental treatment 1 intervention
Group D: VortioxetineExperimental treatment 1 intervention
Group E: DuloxetineExperimental treatment 1 intervention
Group F: AripiprazoleExperimental treatment 1 intervention
Group G: Lithium carbonateExperimental treatment 1 intervention
Group H: OlanzapineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in CDRS-R (Children's Depression Rating Scale) scores from baseline

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 outcomes

1

Change in BDI-II (Baker Depression Scale) scores from baseline

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
2

Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline

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
3

Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)

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
4

Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Chongqing Medical University

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Children's Hospital of Chongqing Medical University

Collaborator

Source ClinicalTrials.gov
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