NeuroStar TMS Shows Efficacy in Treating Depression in Adolescents and Young Adults

Analysis reveals significant industry trends and economic implications

Release Date

2025-07-31

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Neuronetics, Inc. announced the publication of real-world data in JAACAP Open demonstrating the effectiveness of NeuroStar TMS therapy in adolescents and young adults with major depressive disorder (MDD). The study, using data from the world's largest TMS outcomes database (TrakStar), showed approximately 70% of patients (aged 12-21) experienced clinically meaningful improvement. These findings are consistent with previously reported results in adult populations, highlighting NeuroStar's role as a safe and effective treatment option, especially given the limited FDA-approved medications for this age group with significant safety concerns. Neuronetics emphasizes the importance of completing the full treatment course to maximize benefits.

Key Highlights

  • Real-world data shows NeuroStar TMS is effective in adolescents and young adults with MDD.
  • Approximately 70% of patients (aged 12-21) reported clinically meaningful improvement.
  • Findings are consistent with previously reported results in adult populations.
  • NeuroStar is a safe and effective option, especially considering limited and risky alternative medications for this age group.

Incidence and Prevalence

Estimates of Major Depressive Disorder Prevalence and Incidence

Based on the available information, there are significant trends in depression prevalence in the United States, though comprehensive global data is not available in the provided context.

In the USA, the prevalence of depression increased significantly from 2005 to 2015, according to the National Survey on Drug Use and Health (NSDUH) which analyzed data from 607,520 participants. This increase was observed both before and after controlling for demographics.

Specific population groups showing significant increases in depression include: - The youngest and oldest age groups - Men and women - Non-Hispanic White persons - The lowest income group - The highest education and income groups

Notably, the rate of increase was significantly more rapid among youth compared to all older age groups.

As of 2014, approximately 11.6% of US adults met the criteria for lifetime subsyndromal depression (SD). Subsyndromal depression is prevalent in the US population and is associated with: - Elevated rates of Axis I and II psychopathology - Increased psychosocial disability - Risk for incident major depression, dysthymia, social phobia, and generalized anxiety disorder

The majority of those with subsyndromal depression (9.3%) had fewer than 5 total symptoms required for a diagnosis of major depression, while 2.3% reported 5 or more symptoms but denied clinically significant distress or functional impairment.

Research indicates that if DSM-IV criteria are accepted as a diagnostic definition, Major Depression prevalence is considerably higher than usually cited figures. The spectrum of severity is much broader than is usually acknowledged.

It's worth noting that DSM-IV and ICD-10 definitions capture such a broad spectrum of morbidity that they should not be regarded as de facto indicators of need, at least not in community populations.

From a methodological perspective, research suggests that period prevalence estimates are of limited utility in characterizing the longitudinal epidemiology of depression. Markov models provide a methodological framework for increasing the utility of epidemiological data and for decomposing prevalence into its various determinants: incidence, recovery, and mortality.

Key Unmet Needs and Targeted Populations for Major Depressive Disorder

Major depressive disorder (MDD) affects more than 300 million people worldwide, with approximately one in five US adults having a lifetime diagnosis as of 2020. Despite this prevalence, several significant unmet needs persist across various populations:

Current Treatment Limitations

  • Trial-and-error approaches remain standard for MDD treatment, with remission rates remaining low
  • There is an urgent need for reliable biomarkers to enable informed and personalized treatment solutions
  • Recent research suggests heartbeat-evoked potential (HEP) could be used for treatment stratification between venlafaxine and rTMS

Special Populations with Unmet Needs

Older Adults

  • One-third of older adults in the US have depression
  • Treatment typically involves psychotherapy and antidepressants
  • Recent studies show first-line antidepressants were associated with a decreased risk of falls

Patients with Very Poor Prognoses

  • Only 40% of palliative physicians reported screening for depression
  • 77.3% of physicians cited lack of rapidly effective therapeutic options as a barrier
  • 66.7% desired better collaboration between palliative care and psychiatry

Patients with Type 2 Diabetes

  • Depression is the most common psychiatric disorder in diabetic patients
  • Shows a twofold increase associated with suboptimal glycemic control
  • Depressed diabetic patients had higher levels of HbA1c and physical complaints
  • Factors associated with depression include anxiety (OR=49.424), smoking (OR=2.728), and glycated hemoglobin A1c variability

Individuals with Gender Incongruence and Diabetes

  • Depression and anxiety were significantly higher in this population
  • Non-suicidal self-injurious behavior was more common in type 1 diabetes patients with gender incongruence
  • Suicidality was more common in type 2 diabetes patients with gender incongruence

Medicaid Beneficiaries

  • Total US Medicaid expenditure on antidepressants increased from $1 billion (2017) to $1.12 billion (2021)
  • Total prescriptions increased from 52 million to 59 million scripts
  • Trend toward prescribing newer more costly antidepressants

Emerging Treatment Approaches and Gaps

  • Immunometabolic depression (IMD) patients may respond less to antidepressants
  • Exercise therapy decreased the immunometabolic depression index while antidepressants increased it
  • 40 Hz masked flickering light stimulation is being investigated as a potential therapy
  • Mindfulness and compassion programs for individuals with cancer and depression
  • Cultural adaptation of screening tools, as demonstrated by the Mental Health Screening Tool for Depressive Disorders (MHS:D) for Korean patients

Integrative Approaches Needed

  • Limited research exists on combining pharmacological treatments with psychotherapeutic interventions
  • Exercise should be considered an alternative or complementary treatment
  • Gender-specific approaches are needed as symptoms affect treatment adherence differently in men versus women

Expanding Applications of TMS Beyond Major Depressive Disorder

Transcranial magnetic stimulation (TMS) is increasingly being investigated for psychiatric disorders beyond major depressive disorder. While the provided context doesn't specifically mention NeuroStar TMS trials, it does highlight several conditions being explored with TMS technology:

Conditions Under Investigation

  • Schizophrenia spectrum disorders (SSD): TMS is being studied for treating auditory hallucinations by targeting specific neural circuits involved in these symptoms.

  • Anxiety disorders: Research is expanding to include various anxiety conditions, though specific protocols aren't detailed in the context.

  • Fibromyalgia syndrome (FMS): TMS is being investigated for this chronic pain condition that severely reduces quality of life.

  • Other conditions mentioned include:

  • Post-traumatic stress disorder

  • Obsessive-compulsive disorder

  • Panic disorder

  • Generalized anxiety disorder

  • Attention-deficit/hyperactivity disorder

  • Catatonia

  • Bipolar disorder

Intervention Models

Several intervention models are being utilized in these trials:

  1. For schizophrenia, TMS targets neural circuits involved in auditory hallucinations, though specific parameters aren't detailed.

  2. For fibromyalgia, researchers use deep TMS (dTMS) with the H7 HAC coil targeting the:

  3. Anterior cingulate cortex (ACC)

  4. Medial prefrontal cortex (mPFC)

This approach combines dTMS with pain-directed psychotherapeutic intervention, showing significant decreases in sensory and affective pain dimensions.

  1. For treatment-resistant depression (TRD), some studies combine TMS with internet-based cognitive behavioral therapy (iCBT).

  2. General TMS protocols include:

  3. Delivering magnetic pulses to specific brain regions

  4. Targeting the dorsolateral prefrontal cortex (DLPFC) (commonly used for depression)

  5. Using intermittent theta-burst stimulation (iTBS) to the left DLPFC

  6. For maintenance treatment, approaches include:

  7. Scheduled monthly sessions (SCH)

  8. Observation with reintroduction as needed (OBS)

The evidence for TMS in these non-MDD applications is described as "mixed and limited" with no definitive conclusions yet established. However, TMS is considered a "quite novel, non-invasive, well tolerated treatment method with a low amount of transient adverse effects and complications."

As new therapeutic protocols develop, TMS is becoming available to more patient groups with various mental disorders, though availability remains limited in some regions like Poland.