Description of Patient Population11,2*

DSM-IV Diagnosis Unipolar, non-psychotic
Major Depressive Disorder (MDD)
Patients with Previous MDD Episodes 97%
Treatment History in Current Episode # of median treatments attempted: 4
Range of treatments attempted (#): 1-23
# of treatments at adequate dose and duration: 1
Patients Unemployed due to MDD 48%
Patients with Co-morbid Anxiety Disorder 35%
Symptom Severity Baseline MADRS=33, HAMD24=30
(moderate to severe)

* Patient population (N=164) drawn from overall study group (N=301) based on predictors of response analysis (data on file)

Safety Results in Clinical Trials3

More than 10,000 active treatments safely
performed across all NeuroStar clinical trials
  • No seizures
  • No systemic side effects
    • No weight gain
    • No sexual dysfunction
    • No sedation
    • No nausea
    • No dry mouth
  • No adverse effect on cognition
  • Most common adverse events were headache and scalp discomfort
  • Less than 5% discontinuation due to adverse events

Acute MDD Efficacy Results in Randomized, Controlled Trial1

Clinical Study Description:

  • 164 patients in the randomized, sham controlled trial*
  • Triple-blinded (treater, rater and patient)
  • 4-6 weeks of TMS monotherapy

NeuroStar TMS Therapy produced significant improvements in depression symptoms

LOCF analysis of evaluable study population

LOCF analysis of evaluable study population

NeuroStar TMS Therapy significantly improved mood2

LOCF analysis of evaluable study population

LOCF analysis of evaluable study population

* Patient population (N=164) drawn from overall study group (N=301) based on predictors of response analysis (data on file)

Acute MDD Efficacy Results in Open-label Clinical Trial

Clinical Study Description:

  • 43 patients in the open-label trial*
  • 6 weeks of TMS monotherapy

NeuroStar TMS Therapy Response and Remission Rates2

Analysis reported for intent-to-treat evaluable population

Analysis reported for intent-to-treat evaluable population

NeuroStar TMS Therapy compares favorably to antidepressant medications

Values for effect size are expressed as Hedges's g. For pharmaceutical antidepressant studies, the overall effect size was derived from 74 clinical studies that were reported to the FDA and includes 10 FDA-approved antidepressant medications (Turner.) STAR*D monotherapy treatments consisted of citalopram at Level1, bupropion SR, sertraline, or venlafaxine XR at Level 2.

Values for effect size are expressed as Hedges's g. For pharmaceutical antidepressant studies, the overall effect size was derived from 74 clinical studies that were reported to the FDA and includes 10 FDA-approved antidepressant medications (Turner.)

 

STAR*D monotherapy treatments consisted of citalopram at Level1, bupropion SR, sertraline, or venlafaxine XR at Level 2.

* Patient population (N=43) represents the subset of patients who did not benefit from sham treatment in the randomized control trial (data on file)

References:

  1. Thase M, Demitrack M, Evaluating Clinical Significance of Treatment Outcomes in Studies of Resistant Major Depression, Biological Psychiatry, April 1, 2008; Vol. 63:7s Page, 138s.
  2. Data on file.
  3. Janicak, P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression: A Comprehensive Summary of Safety Experience from Acute Exposure, Extended Exposure and During Reintroduction Treatment. Journal of Clinical Psychiatry, 2008; Vol
  4. Turner, et al. Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy. N Engl J Med, 2008;358:252-60
  5. Trivedi, et al. Evaluation of Outcomes with Citalopram for Depression Using Measurement- Based Care in STAR*D: Implications for Clinical Practice. American Journal of Psychiatry, 2006:163:28-40
  6. Rush et al. Bupropion-Sr, Sertaline, or Venlafaxine-XR after failure of SSRIs for Depression. N Engl J Med, 2006;354:12:1231-1242.

Caution: Investigational device. Limited by federal law to investigational use.