- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00149838
Magnetic Brain Stimulation for the Treatment of Adult Depression
Optimization of Transcranial Magnetic Stimulation (TMS) for Depression
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Major depression is a type of depression that can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Because people often develop resistances to medications used to treat depression, new treatments are needed. Decreased electrical activity in the prefrontal region of the brain has been linked to some symptoms of depression. Repetitive transcranial magnetic stimulation (rTMS) can be used to influence the brain's electrical activity. This procedure entails attaching electrodes to the head and using a device to pass magnetic energy through coils and into the brain. rTMS has been shown to have antidepressant effects in depressed individuals. However, optimal levels of intensity and treatment duration have yet to be determined. This study will assess the safety and effectiveness of rTMS on the prefrontal region of the brain in depressed adults with moderate treatment resistance.
The treatment phase of this double-blind study will last a minimum of 32 weeks and will consist of 3 phases. In Phase I, participants will be randomly assigned to receive either rTMS or sham stimulation. The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. In Phase II, participants who were unresponsive to Phase I treatment will receive daily rTMS at a lower dose for 3 weeks. Participants who show signs of improvement, but have not achieved remission, may continue Phase II for 4 additional weeks. Baseline magnetic resonance images will be used to determine the optimal stimulus intensity by adjusting for individual differences in cortical to skull distances. Phase III participants will be only those who achieved remission in the first 2 phases. These participants will receive antidepressant medication treatment daily for six months. Participants' functional status and symptoms of depression will be measured using self-report scales and video-recorded interviews at study start date and at the end of each treatment phase.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30329-5102
- Emory University
-
-
New York
-
New York, New York, Estados Unidos, 10032
- Columbia University
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos, 29425
- Brain Stimulation Laboratory, Medical University of South Carolina
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98104-2499
- University of Washington
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of major depression with a current episode
- Hamilton Rating Scale for Depression score higher than 20
- No response or intolerance to antidepressant medication in the current depressive episode
Exclusion Criteria:
- Current use of antidepressants
- Diagnosis of psychosis or anxiety disorder
- Current substance abuse
- Seizures or history of head trauma
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Active prefrontal rTMS phase1
Phase I participants receiving rTMS
|
Participants receive 120% motor threshold (MT) over left and right prefrontal cortex.
Treatments will be administered daily for 3 weeks.
Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
Otros nombres:
|
Comparador de placebos: Sham rTMS phase 1
Phase I participants receiving sham stimulation
|
The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current.
Treatments will be administered daily for 3 weeks.
|
Experimental: rTMS extension
rTMS.
Phase II participants, all of whom did not meet remission requirements after phase 1.
They all receive active open label rTMS
|
Participants receive 120% motor threshold (MT) over left and right prefrontal cortex.
Treatments will be administered daily for 3 weeks.
Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
Otros nombres:
|
Experimental: Open label antidepressant regimen
All patients who met remission who were then transitioned to medications after the TMS trial was completed.
|
Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Depression Remission, as Measured by the Hamilton Rating Scale for Depression
Periodo de tiempo: Measured at the end of Phases 1, 2, and 3
|
The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression.
Remission is defined as a total score of ≤ 8
|
Measured at the end of Phases 1, 2, and 3
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark S. George, MD, Medical University of South Carolina
Publicaciones y enlaces útiles
Publicaciones Generales
- Borckardt JJ, Nahas ZH, Teal J, Lisanby SH, McDonald WM, Avery D, Durkalski V, Pavlicova M, Long JM, Sackeim HA, George MS. The painfulness of active, but not sham, transcranial magnetic stimulation decreases rapidly over time: results from the double-blind phase of the OPT-TMS Trial. Brain Stimul. 2013 Nov;6(6):925-8. doi: 10.1016/j.brs.2013.04.009. Epub 2013 May 21.
- George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH069887 (Subvención/contrato del NIH de EE. UU.)
- DATR A5-ETMA (Otro identificador: NIH)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Prefrontal rTMS
-
University Health Network, TorontoDesconocidoDepresión mayor | Trastorno límite de la personalidadCanadá
-
United States Naval Medical Center, San DiegoTerminadoPTSD, trastorno de estrés postraumáticoEstados Unidos
-
Masarykova UniverzitaBrno University Hospital; Masaryk UniversityReclutamientoTrastorno límite de la personalidadChequia
-
Washington University School of MedicineTerminado
-
University of CalgaryDefence Research and Development CanadaTerminadoLesiones Cerebrales | Estimulación Magnética Transcraneal | Trastornos de estrés postraumático | Biomarcadores | Depresión ansiedad | Espectroscopía de resonancia magnéticaCanadá
-
Shanghai Mental Health CenterXuhui Mental Health CenterReclutamientoEsquizofrenia | Deterioro Cognitivo | Estimulación magnética transcraneal repetitiva | Síntomas negativos en la esquizofrenia | Corteza prefrontal dorsolateralPorcelana
-
Assistance Publique - Hôpitaux de ParisTerminadoDolor neuropáticoFrancia
-
University of AarhusRetirado
-
University of RegensburgTerminado
-
Medical University of South CarolinaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)TerminadoDependencia del alcoholEstados Unidos