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

NCT ID: NCT07011693

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group1-sertraline

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

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

Commonly used oral antipsychotics intervention therapy.

Group 2-agomelatine

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

Group Type: EXPERIMENTAL

Agomelatine

Intervention Type: DRUG

Commonly used oral antipsychotics intervention therapy.

Group 3-aripiprazole with original SSRI

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

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Commonly used oral antipsychotics intervention therapy.

Interventions

Sertraline

Commonly used oral antipsychotics intervention therapy.

Intervention Type: DRUG

Agomelatine

Commonly used oral antipsychotics intervention therapy.

Intervention Type: DRUG

Aripiprazole

Commonly used oral antipsychotics intervention therapy.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinyu Zhou

OTHER

Sponsor Role: lead

Responsible Party

Xinyu Zhou

Professer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Central Contacts

Xinyu Zhou

Role: CONTACT

zhouxinyu@cqmu.edu.cn

2912-89012912

Facility Contacts

Xinyu Zhou

Role: primary

zhouxinyu@cqmu.edu.cn

2912-89012912

Other Identifiers

1stChongqingCQMU

Identifier Type: -

Identifier Source: org_study_id