Treatment of Bipolar Depression with Deep TMS: Results from a Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial
| Autor: | Beny Lafer, Bernardo Sampaio-Junior, Pedro Caldana Gordon, Rosa M. Rios, Zafiris J. Daskalakis, Diego Freitas Tavares, Wagner F. Gattaz, Martin L Myczkowski, Carlos Gustavo Mansur, Ricardo Alberto Moreno, R.L. Alberto, Leandro Valiengo, Andre R. Brunoni, Izio Klein, Marco Antonio Marcolin |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Bipolar Disorder Patient Dropouts Time Factors medicine.medical_treatment Prefrontal Cortex Young Mania Rating Scale law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law medicine Humans Deep transcranial magnetic stimulation Adverse effect Psychiatry Depression (differential diagnoses) Pharmacology Psychiatric Status Rating Scales Remission Induction Transcranial Magnetic Stimulation Antidepressive Agents 030227 psychiatry Clinical trial Transcranial magnetic stimulation Psychiatry and Mental health Treatment Outcome Anesthesia Female Original Article medicine.symptom Psychology Mania 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology. 42(13) |
| ISSN: | 1740-634X |
| Popis: | Bipolar depression (BD) is a highly prevalent condition with limited therapeutic options. Deep (H1-coil) transcranial magnetic stimulation (dTMS) is a novel TMS modality with established efficacy for unipolar depression. We conducted a randomized sham-controlled trial to evaluate the efficacy and safety of dTMS in treatment-resistant BD patients. Patients received 20 sessions of active or sham dTMS over the left dorsolateral prefrontal cortex (H1-coil, 55 18 Hz 2 s 120% MT trains). The primary outcome was changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline to endpoint (week 4). Secondary outcomes were changes from baseline to the end of the follow-up phase (week 8), and response and remission rates. Safety was assessed using a dTMS adverse effects questionnaire and the Young Mania Rating Scale to assess treatment-emergent mania switch (TEMS). Out of 50 patients, 43 finished the trial. There were 2 and 5 dropouts in the sham and active groups, respectively. Active dTMS was superior to sham at end point (difference favoring dTMS=4.88; 95% CI 0.43 to 9.32, p=0.03) but not at follow-up. There was also a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92; 95% CI=0.87 to 9.78, p=0.08). Remission rates were not statistically different. No TEMS episodes were observed. Deep TMS is a potentially effective and well-tolerated add-on therapy in resistant bipolar depressed patients receiving adequate pharmacotherapy. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink