Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)

NCT07011693 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 1stChongqingCQMU
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder (MDD)

Keywords

adolescent; SSRI; depression

Outcome Measures

Primary Outcomes (1)

• response rate of Children's Depression Rating Scale (CDRS-R) scores

  The primary outcomes are the treatment response rate (reduction rate of CDRS-R≥50%). The CDRS-R is a scale consisting of 17 items that are evaluated by clinicians to assess the intensity of depressive symptoms in adolescents, with items scored on scales of 1 to 5 or 1 to 7, resulting in a possible total score range of 17 to 113，higher scores mean a worse outcome.

  Baseline of treatment period, 4 weeks, 8 weeks

Secondary Outcomes (4)

• 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,

Study Arms (3)

Group1-sertraline

EXPERIMENTAL

dosage form: po dosage:25-200mg frequency:qd duration: patients will be given sertraline as a switching treatment to SSRI.

Drug: Sertraline

Group 2-agomelatine

EXPERIMENTAL

dosage form: po dosage:25-50mg frequency:qd duration: patients will be given agomelatine as a switching treatment to SSRI.

Drug: Agomelatine

Group 3-aripiprazole with original SSRI

EXPERIMENTAL

dosage form: po dosage: 1.25-15mg frequency:qn duration: patientswill be given aripiprazole as an add-on treatment to original SSRI.

Drug: Aripiprazole

Interventions

Sertraline DRUG

Commonly used oral antipsychotics intervention therapy.

Group1-sertraline

Agomelatine DRUG

Commonly used oral antipsychotics intervention therapy.

Group 2-agomelatine

Aripiprazole DRUG

Commonly used oral antipsychotics intervention therapy.

Group 3-aripiprazole with original SSRI

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinyu Zhou: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Sertraline; agomelatine; Aripiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Xinyu Zhou

CONTACT

2912-89012912; zhouxinyu@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 10, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

CN (1)