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Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial.

Publication ,  Journal Article
George, MS; Lisanby, SH; Avery, D; McDonald, WM; Durkalski, V; Pavlicova, M; Anderson, B; Nahas, Z; Bulow, P; Zarkowski, P; Holtzheimer, PE ...
Published in: Arch Gen Psychiatry
May 2010

CONTEXT: Daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) has been studied as a potential treatment for depression, but previous work had mixed outcomes and did not adequately mask sham conditions. OBJECTIVE: To test whether daily left prefrontal rTMS safely and effectively treats major depressive disorder. DESIGN: Prospective, multisite, randomized, active sham-controlled (1:1 randomization), duration-adaptive design with 3 weeks of daily weekday treatment (fixed-dose phase) followed by continued blinded treatment for up to another 3 weeks in improvers. SETTING: Four US university hospital clinics. PATIENTS: Approximately 860 outpatients were screened, yielding 199 antidepressant drug-free patients with unipolar nonpsychotic major depressive disorder. INTERVENTION: We delivered rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations. MAIN OUTCOME MEASURE: In the intention-to-treat sample (n = 190), remission rates were compared for the 2 treatment arms using logistic regression and controlling for site, treatment resistance, age, and duration of the current depressive episode. RESULTS: Patients, treaters, and raters were effectively masked. Minimal adverse effects did not differ by treatment arm, with an 88% retention rate (90% sham and 86% active). Primary efficacy analysis revealed a significant effect of treatment on the proportion of remitters (14.1% active rTMS and 5.1% sham) (P = .02). The odds of attaining remission were 4.2 times greater with active rTMS than with sham (95% confidence interval, 1.32-13.24). The number needed to treat was 12. Most remitters had low antidepressant treatment resistance. Almost 30% of patients remitted in the open-label follow-up (30.2% originally active and 29.6% sham). CONCLUSION: Daily left prefrontal rTMS as monotherapy produced statistically significant and clinically meaningful antidepressant therapeutic effects greater than sham. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00149838.

Duke Scholars

Published In

Arch Gen Psychiatry

DOI

EISSN

1538-3636

Publication Date

May 2010

Volume

67

Issue

5

Start / End Page

507 / 516

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Transcranial Magnetic Stimulation
  • Psychiatry
  • Prefrontal Cortex
  • Middle Aged
  • Male
  • Humans
  • Female
  • Evoked Potentials, Motor
 

Citation

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George, M. S., Lisanby, S. H., Avery, D., McDonald, W. M., Durkalski, V., Pavlicova, M., … Sackeim, H. A. (2010). Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry, 67(5), 507–516. https://doi.org/10.1001/archgenpsychiatry.2010.46

Published In

Arch Gen Psychiatry

DOI

EISSN

1538-3636

Publication Date

May 2010

Volume

67

Issue

5

Start / End Page

507 / 516

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Transcranial Magnetic Stimulation
  • Psychiatry
  • Prefrontal Cortex
  • Middle Aged
  • Male
  • Humans
  • Female
  • Evoked Potentials, Motor