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Completed

NCT Number: NCT05544071

Individualized dlPFC-NAcc Modulation for Anhedonia in adMDD

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation (TMS)

Device

Compare active coil with sham coil.

Other names: TMS, Sertraline

Primary outcomes

  1. 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.

Secondary outcomes

  1. Score of the Hamilton Rating Scale for Depression (HAM-17)

    Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)

    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.

  2. Score of the Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)

    A diagnostic questionnaire used to measure the severity of depressive symptoms. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.

  3. Score of the Chinese version of Temporal Experience of Pleasure Scale(CV-TEPS)

    Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)

    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.

  4. Score of the Chinese version of Beck Scale for Suicide Ideation(BSI-CV)

    Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)

    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.

  5. Score of the Insomnia Severity Index Scale (ISI)

    Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)

    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.

  6. Score of the Clinical Global Impression (CGI)

    Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)

    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.

  7. Score of the Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)

    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.

  8. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Safety and Efficacy of rTMS on Individualized dlPFC-NAcc Functional Connectivity in Adolescents With Depression and Anhedonia: a Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2022
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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