Effect of Repetitive Transcranial Magnetic Stimulation on Treatment-Resistant Major Depression in US Veterans: A Randomized Clinical Trial
| Autor: | Gerald Georgette, Zhibao Mi, Steven D. Forman, Leanne M. Williams, Amit Etkin, Art Noda, J. Kaci Fairchild, Tamara Beale, Ciaran S. Phibbs, Jerome A. Yesavage, Kousick Biswas, Grant D. Huang, Michael E. Thase, Anne Davis-Karim, Mark S. George, Ruth O'Hara |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Suicide Prevention medicine.medical_specialty Population Poison control Veterans Health law.invention Stress Disorders Post-Traumatic 03 medical and health sciences Depressive Disorder Treatment-Resistant 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans education Veterans Affairs Depression (differential diagnoses) Veterans Psychiatric Status Rating Scales education.field_of_study Intention-to-treat analysis business.industry Hamilton Rating Scale for Depression Middle Aged medicine.disease Transcranial Magnetic Stimulation United States 030227 psychiatry Intention to Treat Analysis Psychiatry and Mental health Suicide Treatment Outcome Quality of Life Major depressive disorder Female business 030217 neurology & neurosurgery |
| Zdroj: | JAMA psychiatry. 75(9) |
| ISSN: | 2168-6238 |
| Popis: | Importance Treatment-resistant major depression (TRMD) in veterans is a major clinical challenge given the high risk for suicidality in these patients. Repetitive transcranial magnetic stimulation (rTMS) offers the potential for a novel treatment modality for these veterans. Objective To determine the efficacy of rTMS in the treatment of TRMD in veterans. Design, Setting, and Participants A double-blind, sham-controlled randomized clinical trial was conducted from September 1, 2012, to December 31, 2016, in 9 Veterans Affairs medical centers. A total of 164 veterans with TRD participated. Interventions Participants were randomized to either left prefrontal rTMS treatment (10 Hz, 120% motor threshold, 4000 pulses/session) or to sham (control) rTMS treatment for up to 30 treatment sessions. Main Outcomes and Measures The primary dependent measure of the intention-to-treat analysis was remission rate (Hamilton Rating Scale for Depression score ≤10, indicating that depression is in remission and not a clinically significant burden), and secondary analyses were conducted on other indices of posttraumatic stress disorder, depression, hopelessness, suicidality, and quality of life. Results The 164 participants had a mean (SD) age of 55.2 (12.4) years, 132 (80.5%) were men, and 126 (76.8%) were of white race. Of these, 81 were randomized to receive active rTMS and 83 to receive sham. For the primary analysis of remission, there was no significant effect of treatment (odds ratio, 1.16; 95% CI, 0.59-2.26; P = .67). At the end of the acute treatment phase, 33 of 81 (40.7%) of those in the active treatment group achieved remission of depressive symptoms compared with 31 of 83 (37.4%) of those in the sham treatment group. Overall, 64 of 164 (39.0%) of the participants achieved remission. Conclusions and Relevance A total of 39.0% of the veterans who participated in this trial experienced clinically significant improvement resulting in remission of depressive symptoms; however, there was no evidence of difference in remission rates between the active and sham treatments. These findings may reflect the importance of close clinical surveillance, rigorous monitoring of concomitant medication, and regular interaction with clinic staff in bringing about significant improvement in this treatment-resistant population. Trial Registration ClinicalTrials.gov Identifier:NCT01191333 |
| Databáze: | OpenAIRE |
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