the Safety and Effectiveness of Precise rTMS Based on Neuroimaging in the Treatment of Adolescent Depression With Anhedoniadepression With Anhedonia

November 1, 2023 updated by: Xijing Hospital

A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of Precise Repetitive Transcranial Magnetic Stimulation (rTMS) Therapy Based on Neuroimaging in Depressed Adolescents With Anhedonia.

This study evaluates a schedule of precise repetitive transcranial magnetic stimulation for depressive adolescent with anhedonia. In this randomized controlled trial, half of the participants will receive repetitive transcranial magnetic stimulation, and the other will receive sham stimulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression among adult. The approved method for treatment is 10Hz stimulation over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been successful for many people with treatment-resistant depression. However, a large percentage of adolescents suffering from major depressive disorder (MDD) do not adequately benefit from currently available treatments. One of the limitations is concerns about the safety and efficacy of antidepressant. Recently, researchers have aggressively pursued better treatment strategy such as rTMS to improve adolescent depression with some preliminary success. This study intends to further explore the safety and efficacy of rTMS in the treatment for adolescent major depressive disorder with anhedonia. This study will also look at the change in neuroimaging biomarkers associated with this treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female, 13 to 18 years of age.
  • According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE).
  • Meet the threshold on the total HAMD17 score of >/=17 at both screening and baseline visits (Day -7 and Day 0).
  • Meet the threshold on the total SHAPS score of >/=20 at both screening and baseline visits (Day -7 and Day 0).
  • Not take any antidepressants for two or more weeks before screening.
  • In good general health, as ascertained by medical history.
  • After fully understanding the treatment of transcranial magnetic stimulation, willing to cooperate with the treatment actively and able to provide informed consent.

Exclusion Criteria:

  • Current diagnosis of a Substance Use Disorder, with the exception of nicotine and caffeine dependence.
  • Current diagnosis of mental disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
  • History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
  • Any other Mental Disorders, Personality Disorders, Intellectual Disability, which at screening is clinically predominant to their MDD.
  • Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
  • Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
  • Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
  • History of electronic instrument or metal in the head or skull.
  • History of epilepsy.
  • History of cardiovascular disease or cardiac event.
  • History of OCD.
  • History of autism spectrum disorder.
  • History of rTMS exposure.
  • Other situations judged by the researchers to be unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: rTMS Active
Blinded Active TMS coil. Active repetitive Transcranial Magnetic Stimulation (rTMS) and Sertraline (dosage form: pill, dosage: 50mg, frequency and duration: At the beginning of the treatment, the dose of 25mg/ was taken for 1-3 days and adjusted to 50mg/ days for 4-7 days. If there were no dose-limiting adverse events, the dose could be titrated to 100mg/ days in the second week. The dose could be flexibly adjusted within the range of 100~150mg/ days until a satisfactory clinical response was achieved. After that, the drug dose was kept unchanged as far as possible. Take it once a day, after a meal at a relatively fixed time in the morning.)
Device: Transcranial Magnetic Stimulation (TMS)
Compare active coil with sham coil.
Other Names:
  • Sertraline
  • TMS
Sham Comparator: rTMS Sham
Blinded Sham TMS coil. Sham Transcranial Magnetic Stimulation (TMS) and Sertraline (dosage form: pill, dosage: 50mg, frequency and duration: At the beginning of the treatment, the dose of 25mg/ was taken for 1-3 days and adjusted to 50mg/ days for 4-7 days. If there were no dose-limiting adverse events, the dose could be titrated to 100mg/ days in the second week. The dose could be flexibly adjusted within the range of 100~150mg/ days until a satisfactory clinical response was achieved. After that, the drug dose was kept unchanged as far as possible. Take it once a day, after a meal at a relatively fixed time in the morning.)
Device: Transcranial Magnetic Stimulation (TMS)
Compare active coil with sham coil.
Other Names:
  • Sertraline
  • TMS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change in the Snaith-Hamilton Pleasure Scale (SHAPS)Score From Pre-treatment to 8-weeks
Time Frame: Pre-treatment and 8-weeks post treatment
A 14 item self-assessment questionnaire used to measure the severity of anhedonia symptom in patients with mood disorders. Scale range - 14 to 56 with higher score indicative of greater anhedonia symptomology.
Pre-treatment and 8-weeks post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change in the Hamilton Rating Scale for Depression (HAM-17)
Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
A provider administered questionnaire used to assess remission and recovery from depression. Scale range - 0 to 52 with higher score indicative of greater depressive symptomology. Additional collection time points were prespecified; only those time points for which data were collected are reported.
Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
Percent Change in the Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Time Frame: Pre-treatment to 1 week and15days, 4 weeks, 6 weeks and 8 weeks post-treatment
A diagnostic questionnaire used to measure the severity of depressive symptoms. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
Time Frame: Pre-treatment to 1 week and15days, 4 weeks, 6 weeks and 8 weeks post-treatment
Percent Change in the Chinese version of Temporal Experience of Pleasure Scale(CV-TEPS)
Time Frame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
A 20 item self-assessment questionnaire, eleven items used to measure anticipatory anhedonia, and nine items used to evaluate consummatory anhedonia. Scale range - 0 to 140 with lower score indicative of greater anhedonia symptomology.
Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
Percent Change in the Chinese version of Beck Scale for Suicide Ideation（BSI-CV）
Time Frame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
A 19 item questionnaire used to evaluate the severity of suicidal ideation. The scale includes two subscales of suicidal ideation (Current suicidal ideation, BSI-C) and suicidal ideation (Suicidal ideation at one's worst point, BSI-W) in the last week. Scale range - 0 to 38, the higher the score of the subscale, the higher the level of suicidal ideation in the last week or the most serious.
Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
Percent Change in the Insomnia Severity Index Scale （ISI）
Time Frame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
The questionnaire consists of seven items: the severity of insomnia symptoms, the satisfaction of sleep patterns, the effects of insomnia on daytime function, the effects of insomnia on subjects' quality of life, and the degree of worry or depression caused by insomnia. Scale range - 0 to 28 with higher score indicative of greater Insomnia symptomology.
Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
Percent Change in the Clinical Global Impression (CGI)
Time Frame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
The questionnaire used to evaluate the clinical efficacy, it includes three parts: severity of illness (SI), global improvement (GI) and effect index (EI). With higher score indicative of more serious disease and worse effect.
Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
Percent Change in the Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
A 14 item self-assessment questionnaire used to measure the severity of anhedonia symptom in patients with mood disorders. Scale range - 14 to 56 with higher score indicative of greater anhedonia symptomology.
Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
Change From Baseline Functional Connectivity to 15-days Post-treatment
Time Frame: Time Frame: Pre-treatment, immediately post-treatment (on day 15)
We will assess change in resting state fMRI functional connectivity of the nucleus accumbens to the Dorsolateral Prefrontal Cortex and within the reward-related circuits
Time Frame: Pre-treatment, immediately post-treatment (on day 15)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A digital tool named THINC-it® to help assess cognitive functioning
Time Frame: Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment
THINC-it® is a screening tool designed to measure cognition, is based on a combination of specific (traditional) neuropsychological tests assessing cognitive functioning, in conjunction with a patient-reported questionnaire.
Time Frame: Pre-treatment to 1 week and 15days, 4 weeks, 6 weeks and 8 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20222165-F-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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