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MAJOR DEPRESSIVE DISORDER (MDD)

Major Depressive Disorder is a neuropsychiatric disorder that is expressed in emotional, physiological and behavioral effects. Depression is common, chronic and severely damages quality of life, often leading to risk due to suicidal tendencies. Over 12% of the American population suffers from depression over the course of their lifetime.

Drug Therapy

There are a number antidepressant medications designed for major depressive disorder treatment. The main classes of antidepressantsare selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), which include Prozac-like drugs; as well as other newer antidepressants. These drugs affect additional neurotransmitters that may involve depression, such as dopamine.

Electro-Convulsive Therapy (ECT)

Electro-convulsive therapy is usually administered in cases of severe depression, in which drug therapy is ineffective or not an option, and in which depression directly threatens a patient’s life. ECT requires hospitalization, and is administered under full general anesthesia. This depression treatment is administered by attaching electrodes to precise locations on the scalp and passing electrical current through them for a brief period of 30 seconds. ECT typically consists of a series of 6-12 treatment sessions, two to three times a week.

Psychotherapy

Psychotherapy is normally used to augment drug therapy or ECT as a depression treatment. Psychotherapy alone is not recommended for patients with moderate or serious depressive episodes, but rather only for mild cases of depression. Psychotherapy is by its very nature a lengthy process, and its success largely correlates to the skill of the therapist. Research has shown that psychotherapy and support groups can have a certain influence on patients’ ability to continue drug therapy.

Standard Transcranial Magnetic Stimulation (TMS)

Standard TMS involves repetitive interference with the brain electrical activity, inducing high levels of neural activity while the treatemnet is being delivered, with long-lasting effects thereafter. Brief repetitive stimulation triggers a process of learning and a state of plasticity in the brain, which allows long-lasting effects to be exerted on neural activity in target brain areas.

BrainsWay D for Depression

BrainsWay D for depression utilizes a unique, patented device that stimulates deeper and broader neuronal targets than other TMS alternatives. It offers high efficacy and is both non-invasive and well-tolerated for the treatment of major depressive disorder. The treatment involves magnetic stimulation of deeper and broader brain regions which have been shown to be responsible for depression, bringing significant improvement to many patients. It is an outpatient procedure and does not require hospitalization or anesthesia, and entails no systemic side effects.

Randomized controlled trial of BrainsWay D for MDD –
Remission rates at week 5

*Levkovitz et al.,World Psychiatry 2015;14:64–73/2 George et al.Arch Gen Psychiatry,2010;67:507-516/3Typical treatment protocol

BrainsWay D in real life

*Data on file

Clinical Trials

BrainsWay has conducted a clinical trial* using Deep TMS (deep transcranial magnetic stimulation) for depression treatment*: Major Depression – Multicenter Double Blind Randomized Controlled Trial for Tolerability, Safety and Efficacy of the H-Coil Deep TMS. Click here for more information about this clinical trial.

Following this trial, the FDA granted wide indication for BrainsWay D for depression to be used in cases of treatment-resistant depression in patients who did not benefit from any number of previous medication treatments. BrainsWay D for depression is approved by the FDA and by ANVISA for treating major depressive disorder*.

Real Life Clinical Practice using BrainsWay D for Depression

In real-life clinical practice settings, 20 sessions of BrainsWay D resulted in remission rates that were even higher than those observed in randomized controlled clinical trials1. Among patients who went on to complete a treatment course of 30 sessions, 1 in 2 achieved full remission, suggesting a definite benefit for patients completing the full 30-session treatment regimen.

1 Data on file.

2 In the pivotal study which originally led to BrainsWay’s FDA clearance for MDD, response rates after 20 sessions were 38.4% (v. 21.4% with sham) and remission rates were 32.6% (v. 14.6% with sham). *

For references click here

IMPORTANT: BrainsWay is at different stages of regulatory approval for different indications in different countries. While the status of our regulatory approvals is generally updated on this website, in order to verify whether BrainsWay is currently approved in your area for the treatment of this indication, please contact us at info@brainsway.com

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