Magnetic Brain Stimulation for the Treatment of Adult Depression
Optimization of Transcranial Magnetic Stimulation (TMS) for Depression
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329-5102
- Emory University
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Brain Stimulation Laboratory, Medical University of South Carolina
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Washington
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Seattle, Washington, Forenede Stater, 98104-2499
- University of Washington
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
|
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Placebo komparator: 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.
|
|
Eksperimentel: 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.
Andre navne:
|
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Eksperimentel: Open label antidepressant regimen
All patients who met remission who were then transitioned to medications after the TMS trial was completed.
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Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Depression Remission, as Measured by the Hamilton Rating Scale for Depression
Tidsramme: Measured at the end of Phases 1, 2, and 3
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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
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Measured at the end of Phases 1, 2, and 3
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark S. George, MD, Medical University of South Carolina
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH069887 (U.S. NIH-bevilling/kontrakt)
- DATR A5-ETMA (Anden identifikator: NIH)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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