Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial

Plain English Summary

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I) is a Phase 4 clinical trial sponsored by Xinyu Zhou studying Major Depressive Disorder (MDD). This study tests different medication strategies for adolescents whose depression hasn't improved with a common antidepressant. It's for teenagers aged 12-17 diagnosed with major depression who have already tried and not responded to a specific type of antidepressant. Participants will be randomly assigned to one of the treatment groups, and their progress will be monitored over 8 weeks. Alternatives include continuing current treatment, trying different antidepressants, or exploring non-medication therapies like psychotherapy. The trial aims to enroll 400 participants.

Official Summary

This project aims to investigate the effectiveness of existing common antidepressants in adolescents with MDD who did not respond to their first treatment.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adolescents aged 12 to 17 years old. Must have a diagnosis of major depressive disorder that has not improved after at least 8 weeks of a standard antidepressant (fluoxetine or equivalent at a specific dose). Cannot have other specific mental health conditions like bipolar disorder, schizophrenia, autism, ADHD, OCD, or psychosis. Cannot have current suicidal plans or behaviors, or certain neurological conditions. This trial is studying Major Depressive Disorder (MDD), so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how many patients show a significant improvement in their depression symptoms, indicating the effectiveness of the new treatment strategies. The specific primary outcome measures are: response rate of Children's Depression Rating Scale (CDRS-R) scores (Baseline of treatment period, 4 weeks, 8 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial addresses a significant gap in adolescent mental healthcare by investigating more effective treatment options for those who don't respond to initial antidepressant therapy. This research targets Major Depressive Disorder (MDD), where improved treatment options are needed.

Investor Insight

This trial signals a focus on improving outcomes for a common and challenging adolescent mental health condition, potentially leading to new treatment guidelines and market opportunities for effective This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor about the specific medications being tested and what to expect regarding side effects. Participation involves regular clinic visits for assessments and medication management over an 8-week period. You will be monitored closely for any changes in your mood, symptoms, and overall well-being. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 400 participants

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 Outcomes

• response rate of Children's Depression Rating Scale (CDRS-R) scores (Baseline of treatment period, 4 weeks, 8 weeks)

Secondary Outcomes

• Change in Baker Depression Scale（BDI-II) scores from baseline (Baseline of treatment period, 4 weeks, 8 weeks)
• Change in The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scores from baseline (Baseline of treatment period, 4 weeks，8 weeks)
• Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline (Baseline of treatment period, 4 weeks, 8 weeks,)
• Adverse Event (AE) or Serious Adverse Event (SAE) (Baseline of treatment period, 1 month, 2 months,)

Full Eligibility Criteria

Inclusion Criteria:

1. Aged 12-17;
2. As assessed by K-SADS-PL, it meets the DSM-5 criteria for MDD;
3. CDRS-R≥45;
4. CGI-S≥4;
5. 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:

1. Current or lifetime diagnosis of bipolar disorder, schizophrenia, autism, attention-deficit/hyperactivity disorder or obsessive-compulsive disorder or psychosis not otherwise specified;
2. MDD with psychotic symptoms;
3. YMRS\>13;
4. Current or lifetime diagnosis of serious neurologic diseases such as epilepsy, brain trauma or other serious physical illnesses;
5. 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);
6. History of clear-cut intolerability of, or lack of effect with, an adequate trial of sertraline, agomelatine, or aripiprazole;
7. Current depressive episode with clear suicidal plans or behaviors;
8. Received modified electroconvulsive therapy within 3 months;
9. Taking any medicine that contraindicates in combination with or interferes with the efficacy of the treatment;
10. Substance abuse or dependence;
11. Female patients with pregnancy.

Trial Locations

• The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

Frequently Asked Questions

Related Conditions

• Major Depressive Disorder (MDD)
• Adolescent Depression
• Treatment-Resistant Depression
• Antidepressant Non-Response
• Pediatric Mental Health
• Mood Disorders
• Anxiety Disorders
• Psychiatric Drug Development
• Clinical Trial Methodology
• Adolescent Psychiatry

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