Understanding FDA not Cleared for SCHIZOPHRENIA

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Schizophrenia is a complex and often debilitating mental health condition. 

While antipsychotic medications are frequently effective at managing the positive symptoms of schizophrenia—such as hallucinations and delusions—enabling many patients to lead fulfilling lives, a significant and persistent challenge remains: the negative symptoms.

These negative symptoms can encompass a wide range of issues, including emotional unresponsiveness (blunted affect), significant difficulty with cognitive and social skills, and a pronounced lack of energy or motivation (often described as lethargy or avolition).

It's crucial to understand that these negative symptoms not only lead to a progressive decline in a patient's quality of life but can also severely hinder the effectiveness of other crucial psychological and psychiatric treatments that often complement medication therapy.


Currently, there are no medications specifically approved by the FDA to treat these negative symptoms, and even newer generation drugs have not shown significant improvement in this challenging area.


Given that schizophrenia is associated with hypofrontality (a condition characterized by reduced activity in the frontal lobe of the brain), repeated stimulation of these prefrontal regions and the deeper brain networks connected to them, potentially through advanced methods like Deep TMS, might have long-term beneficial effects on neuronal excitability. 

This targeted approach could offer an effective way to address the severe negative symptoms of schizophrenia. Additionally, many individuals with schizophrenia experience distressing auditory hallucinations, which are another area of focus for potential treatment.


Deep TMS therapy works by delivering magnetic stimulation to specific brain structures and networks that are believed to be responsible for the negative symptoms of schizophrenia, leading to significant improvement for patients. 


This treatment boasts several practical advantages: it is an outpatient procedure, meaning it does not require hospitalization or anesthesia, making it more accessible and less disruptive to a patient's life. 

It is also generally well-tolerated and comes with minimal systemic side effects, providing a favorable profile compared to the often harsh and unwanted side effects associated with some conventional oral medications.


Multiple studies and meta-analyses show that rTMS/Deep TMS is effective in ameliorating negative symptoms. 

Some studies report statistically significant reductions in scores on scales like SANS (Scale for the Assessment of Negative Symptoms) and PANSS-N (Positive and Negative Syndrome Scale - Negative Subscale) compared to sham treatment (e.g., SMD for SANS around 0.89, PANSS-N around 0.67, favoring TMS).

Cognitive Improvement: There's evidence of improvement in certain cognitive domains, particularly executive functions, working memory, and immediate/delayed memory.


Functional Gains: By addressing negative and cognitive symptoms, Deep TMS can indirectly lead to improved daily functioning and quality of life, which is a key goal in schizophrenia management, often elusive with traditional antipsychotics alone.

Specific Symptom Targets: While not consistently reducing psychotic (positive) symptoms in all studies, Deep TMS has shown potential for improving executive functions and specifically targeting negative symptoms.



Mechanism: It works by modulating neural activity in regions like the prefrontal cortex, which is often hypoactive in schizophrenia.


Well-tolerated: Generally considered safe with mild side effects (headache, scalp discomfort) and no significant increase in serious adverse events like worsening psychosis or seizures compared to sham. 


In Summary

Schizophrenia, a complex mental health condition, presents a significant challenge primarily due to its persistent negative symptoms, for which conventional medications offer limited relief. 


Deep TMS, with its ability to stimulate deeper brain regions associated with these symptoms, emerges as a promising, non-invasive therapeutic option.


Curious about How BrainsWay Deep TMS® could transform your Health?

BrainsWay Deep TMS® offers innovative approaches not only for neurological and psychiatric conditions. 


Important disclaimer

BrainsWay Deep TMS® Treatment for Schizophrenia is not intended for individuals in the United States as it HAS NOT BEEN FULLY CLEARED by the FDA for safety and efficacy for these specific indications. 


 "It is important to note that while these specific indications may not be FDA-cleared in the United States, some BrainsWay Deep TMS® treatments for certain conditions may have received CE Mark approval in Europe, indicating compliance with European health, safety, and environmental protection standards. Always verify the regulatory status of any treatment in your specific region."