Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sertraline, Agomelatine, Aripiprazole.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD). Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial
Overview
This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.
Detailed description
This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment. Adolescents ages 12 to 17, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) at least 8 weeks and still experiencing depression, participate in a 8-week randomized treatment study that includes one of three conditions: (1) switching to sertraline , (2) switching to duloxetine , (3) augmentation of their original SSRI with aripiprazole.
Interventions
- Drug Sertraline
Commonly used oral antipsychotics intervention therapy. - Drug Agomelatine
Commonly used oral antipsychotics intervention therapy. - Drug Aripiprazole
Commonly used oral antipsychotics intervention therapy.
Primary outcome measures
- response rate of Children's Depression Rating Scale (CDRS-R) scores [Time frame: Baseline of treatment period, 4 weeks, 8 weeks]
Secondary outcome measures (4)
- Change in Baker Depression Scale（BDI-II) scores from baseline [Time frame: Baseline of treatment period, 4 weeks, 8 weeks]
- Change in The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scores from baseline [Time frame: Baseline of treatment period, 4 weeks，8 weeks]
- Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline [Time frame: Baseline of treatment period, 4 weeks, 8 weeks,]
- Adverse Event (AE) or Serious Adverse Event (SAE) [Time frame: Baseline of treatment period, 1 month, 2 months,]
Eligibility criteria
Inclusion criteria
- Aged 12-17;
- As assessed by K-SADS-PL, it meets the DSM-5 criteria for MDD;
- CDRS-R≥45;
- CGI-S≥4;
- Failed to respond to an initial SSRI trial: the trial at least 8 weeks, with the last of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent.
Exclusion criteria
- Current or lifetime diagnosis of bipolar disorder, schizophrenia, autism, attention-deficit/hyperactivity disorder or obsessive-compulsive disorder or psychosis not otherwise specified;
- MDD with psychotic symptoms;
- YMRS>13;
- Current or lifetime diagnosis of serious neurologic diseases such as epilepsy, brain trauma or other serious physical illnesses;
- Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length (at least 8 weeks, with the last 4 of which were at a dosage of at least 40 mg per day of fluoxetine or its equivalent);
- History of clear-cut intolerability of, or lack of effect with, an adequate trial of sertraline, agomelatine, or aripiprazole;
- Current depressive episode with clear suicidal plans or behaviors;
- Received modified electroconvulsive therapy within 3 months;
- Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment;
- Substance abuse or dependence;
- Female patients with pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
Identifiers
NCT: NCT07011693 · 1stChongqingCQMU