Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression

Assessment of relapse during a 6-month, multisite, open-label study

Philip G. Janicak, Ziad Nahas, Sarah H. Lisanby, H. Brent Solvason, Shirlene M. Sampson, William M. McDonald, Lauren B. Marangell, Peter B. Rosenquist, William Vaughn McCall, James Kimball, John P. O'Reardon, Colleen Loo, Mustafa H. Husain, Andrew Krystal, William Gilmer, Sheila M. Dowd, Mark A. Demitrack, Alan F. Schatzberg

Research output: Contribution to journalReview article

84 Citations (Scopus)

Abstract

Background Although transcranial magnetic stimulation (TMS) can be an effective acute antidepressant treatment, few studies systematically examine persistence of benefit. Objective We assessed the durability of antidepressant effect after acute response to TMS in patients with major depressive disorder (MDD) using protocol-specified maintenance antidepressant monotherapy. Methods Three hundred one patients were randomly assigned to active or sham TMS in a 6-week, controlled trial. Nonresponders could enroll in a second, 6-week, open-label study. Patients who met criteria for partial response (i.e., .25% decrease from the baseline HAMD 17) during either the sham-controlled or open-label study (n 5 142) were tapered off TMS over 3 weeks, while simultaneously starting maintenance antidepressant monotherapy. Patients were then followed for 24 weeks in a naturalistic follow-up study examining the long-term durability of TMS. During this durability study, TMS was readministered if patients met prespecified criteria for symptom worsening (i.e., a change of at least one point on the CGI-S scale for 2 consecutive weeks). Relapse was the primary outcome measure. Results Ten of 99 (10%; Kaplan-Meier survival estimate 5 12.9%) patients relapsed. Thirty-eight (38.4%) patients met criteria for symptom worsening and 32/38 (84.2%) reachieved symptomatic benefit with adjunctive TMS. Safety and tolerability were similar to acute TMS monotherapy. Conclusions These initial data suggest that the therapeutic effects of TMS are durable and that TMS may be successfully used as an intermittent rescue strategy to preclude impending relapse.

Original languageEnglish (US)
Pages (from-to)187-199
Number of pages13
JournalBrain Stimulation
Volume3
Issue number4
DOIs
StatePublished - Jan 1 2010
Externally publishedYes

Fingerprint

Transcranial Magnetic Stimulation
Depression
Recurrence
Antidepressive Agents
Therapeutics
Maintenance
Major Depressive Disorder
Kaplan-Meier Estimate
Therapeutic Uses
Outcome Assessment (Health Care)
Safety
Survival

Keywords

  • Antidepressant
  • Clinical trial
  • Maintenance of effect
  • Major depression
  • TMS
  • Treatment resistance

ASJC Scopus subject areas

  • Neuroscience(all)
  • Biophysics
  • Clinical Neurology

Cite this

Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression : Assessment of relapse during a 6-month, multisite, open-label study. / Janicak, Philip G.; Nahas, Ziad; Lisanby, Sarah H.; Solvason, H. Brent; Sampson, Shirlene M.; McDonald, William M.; Marangell, Lauren B.; Rosenquist, Peter B.; McCall, William Vaughn; Kimball, James; O'Reardon, John P.; Loo, Colleen; Husain, Mustafa H.; Krystal, Andrew; Gilmer, William; Dowd, Sheila M.; Demitrack, Mark A.; Schatzberg, Alan F.

In: Brain Stimulation, Vol. 3, No. 4, 01.01.2010, p. 187-199.

Research output: Contribution to journalReview article

Janicak, PG, Nahas, Z, Lisanby, SH, Solvason, HB, Sampson, SM, McDonald, WM, Marangell, LB, Rosenquist, PB, McCall, WV, Kimball, J, O'Reardon, JP, Loo, C, Husain, MH, Krystal, A, Gilmer, W, Dowd, SM, Demitrack, MA & Schatzberg, AF 2010, 'Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: Assessment of relapse during a 6-month, multisite, open-label study', Brain Stimulation, vol. 3, no. 4, pp. 187-199. https://doi.org/10.1016/j.brs.2010.07.003
Janicak, Philip G. ; Nahas, Ziad ; Lisanby, Sarah H. ; Solvason, H. Brent ; Sampson, Shirlene M. ; McDonald, William M. ; Marangell, Lauren B. ; Rosenquist, Peter B. ; McCall, William Vaughn ; Kimball, James ; O'Reardon, John P. ; Loo, Colleen ; Husain, Mustafa H. ; Krystal, Andrew ; Gilmer, William ; Dowd, Sheila M. ; Demitrack, Mark A. ; Schatzberg, Alan F. / Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression : Assessment of relapse during a 6-month, multisite, open-label study. In: Brain Stimulation. 2010 ; Vol. 3, No. 4. pp. 187-199.
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abstract = "Background Although transcranial magnetic stimulation (TMS) can be an effective acute antidepressant treatment, few studies systematically examine persistence of benefit. Objective We assessed the durability of antidepressant effect after acute response to TMS in patients with major depressive disorder (MDD) using protocol-specified maintenance antidepressant monotherapy. Methods Three hundred one patients were randomly assigned to active or sham TMS in a 6-week, controlled trial. Nonresponders could enroll in a second, 6-week, open-label study. Patients who met criteria for partial response (i.e., .25{\%} decrease from the baseline HAMD 17) during either the sham-controlled or open-label study (n 5 142) were tapered off TMS over 3 weeks, while simultaneously starting maintenance antidepressant monotherapy. Patients were then followed for 24 weeks in a naturalistic follow-up study examining the long-term durability of TMS. During this durability study, TMS was readministered if patients met prespecified criteria for symptom worsening (i.e., a change of at least one point on the CGI-S scale for 2 consecutive weeks). Relapse was the primary outcome measure. Results Ten of 99 (10{\%}; Kaplan-Meier survival estimate 5 12.9{\%}) patients relapsed. Thirty-eight (38.4{\%}) patients met criteria for symptom worsening and 32/38 (84.2{\%}) reachieved symptomatic benefit with adjunctive TMS. Safety and tolerability were similar to acute TMS monotherapy. Conclusions These initial data suggest that the therapeutic effects of TMS are durable and that TMS may be successfully used as an intermittent rescue strategy to preclude impending relapse.",
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T1 - Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression

T2 - Assessment of relapse during a 6-month, multisite, open-label study

AU - Janicak, Philip G.

AU - Nahas, Ziad

AU - Lisanby, Sarah H.

AU - Solvason, H. Brent

AU - Sampson, Shirlene M.

AU - McDonald, William M.

AU - Marangell, Lauren B.

AU - Rosenquist, Peter B.

AU - McCall, William Vaughn

AU - Kimball, James

AU - O'Reardon, John P.

AU - Loo, Colleen

AU - Husain, Mustafa H.

AU - Krystal, Andrew

AU - Gilmer, William

AU - Dowd, Sheila M.

AU - Demitrack, Mark A.

AU - Schatzberg, Alan F.

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N2 - Background Although transcranial magnetic stimulation (TMS) can be an effective acute antidepressant treatment, few studies systematically examine persistence of benefit. Objective We assessed the durability of antidepressant effect after acute response to TMS in patients with major depressive disorder (MDD) using protocol-specified maintenance antidepressant monotherapy. Methods Three hundred one patients were randomly assigned to active or sham TMS in a 6-week, controlled trial. Nonresponders could enroll in a second, 6-week, open-label study. Patients who met criteria for partial response (i.e., .25% decrease from the baseline HAMD 17) during either the sham-controlled or open-label study (n 5 142) were tapered off TMS over 3 weeks, while simultaneously starting maintenance antidepressant monotherapy. Patients were then followed for 24 weeks in a naturalistic follow-up study examining the long-term durability of TMS. During this durability study, TMS was readministered if patients met prespecified criteria for symptom worsening (i.e., a change of at least one point on the CGI-S scale for 2 consecutive weeks). Relapse was the primary outcome measure. Results Ten of 99 (10%; Kaplan-Meier survival estimate 5 12.9%) patients relapsed. Thirty-eight (38.4%) patients met criteria for symptom worsening and 32/38 (84.2%) reachieved symptomatic benefit with adjunctive TMS. Safety and tolerability were similar to acute TMS monotherapy. Conclusions These initial data suggest that the therapeutic effects of TMS are durable and that TMS may be successfully used as an intermittent rescue strategy to preclude impending relapse.

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