Repetitive Transcranial Magnetic Stimulation in Breast Cancer Patients With Depression and Anxiety

Brief Summary

Official Title: “A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Breast Cancer Patients With Depression and Anxiety”

Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is associated with high rates of depression and anxiety among its sufferers, and cancer patients with depression usually have worse treatment outcomes and long-term survival. Surprisingly, many cancer patients with depression do not receive treatment for their depression, perhaps because treatments for cancer-related depression are usually adapted from those used in non-cancer populations and may not be suitable for cancer patients. Moreover, cancer patients with depression are more likely to have a long latency of anti-depressant drug action, negative drug-drug interactions with cancer chemotherapies and an increased susceptibility for systemic side effects. Repetitive transcranial magnetic stimulation (rTMS) is a new treatment modality for depression that affects the brain directly with no systemic side effects and poses no potential for drug-drug interactions. rTMS therapy was recently cleared by the FDA as an antidepressant treatment for treatment-resistant Major Depressive Disorder, and now is being evaluated for a wide array of additional psychiatric indications. This randomized, open label, two-arm, pilot study will investigate the safety, tolerability, feasibility and the efficacy of two forms of rTMS (i.e., left (fast) and right (slow) sided rTMS) in cancer-related depression. The study hypotheses are that rTMS will significantly reduce symptoms of depression and that right-sided slow rTMS will be more effective than left-sided fast rTMS for the treatment of severe anxiety.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: August 2015

Interventions Used in this Clinical Trial

  • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Right-Sided Low-Frequency rTMS
    • Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks.
  • Experimental: Left-Sided High-Frequency rTMS
    • Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks.

Outcome Measures for this Clinical Trial

Primary Measures

  • Overall change in depression severity
    • Time Frame: 0, 2, 4, and 6 weeks
      Safety Issue?: No
  • Relative change in depression severity
    • Time Frame: 0, 2, 4, and 6 weeks
      Safety Issue?: No
  • Presence and changes in severity of side effects
    • Time Frame: 0, 2, 4, and 6 weeks
      Safety Issue?: Yes

Secondary Measures

  • Overall change in anxiety severity
    • Time Frame: Weekly (starting with week 0 through week 6)
      Safety Issue?: No
  • Relative change in anxiety severity
    • Time Frame: Weekly (starting with week 0 through week 6)
      Safety Issue?: No
  • Correlation of anxiety with change in depression severity
    • Time Frame: 0 and 6 weeks
      Safety Issue?: No
  • Correlation of anxiety with harm avoidance personality trait
    • Time Frame: Baseline
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Female
  • Age 22-70
  • Had a previous diagnosis of breast cancer (any type or stage) confirmed by official medical records
  • Has a DSM IV diagnosis of Major Depressive Disorder
  • Has a HAM-D 24-item score of more than 20
  • Failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current depressive episode
  • All participants must have given signed, informed consent prior to registration in study

Exclusion Criteria

  • Participant had breast cancer with brain metastases
  • There is evidence of the disease at the time of entry into the trial
  • Presence or recent history of other concurrent cancers, with the following exceptions:
  • Participants with completely treated basal or squamous skin cancers can be included in the study if their physicians deem that they are medically stable
  • Participants with completely treated in situ carcinoma of the breast or cervix may be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable
  • Participants with pre-cancerous lesions in the colon can be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable
  • Participant had recent surgery (within two weeks)
  • Participant is undergoing chemotherapy
  • Participant is pregnant or nursing
  • Participant has any metallic object in or around their head
  • Participant has a pacemaker
  • Has unstable suicidal ideation as determined by the patient's treating psychiatrist
  • Substance use disorder within the prior six months
  • Significant history of head injury/trauma as defined by loss of consciousness for more than 1 hour
  • Recurring seizures resulting from the head injury
  • Clear cognitive sequelae from the head injury and cognitive rehabilitation following the injury
  • Any disorder that would predispose the participant to seizures
  • Use of concomitant medications that substantially increase seizure risk. Such drugs could include neuroleptics (ex. haloperidol, droperidol), clozapine, tricyclic antidepressants (ex. amoxapine, clomipramine), bupropion (particularly the immediate release – IR – formulation) donepezil, psychostimulants (ex. methylphenidate), theophylline and/or other drugs that reduce the seizure threshold. For individuals on any of these medicines, a study clinician will evaluate the drugs and doses to determine the risks and benefits. These will then be discussed with the individual's Primary Care Physician to determine if the individual should be excluded from the study.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 22 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Northwestern University
  • Collaborator
    • Neuronetics
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mehmet Dokucu, Assistant Professor of Psychiatry – Northwestern University
  • Overall Official(s)
    • Mehmet Dokucu, MD, PhD, Principal Investigator, Northwestern University
  • Overall Contact(s)
    • Marko Mihailovic, (312) 503-9096, marko.mihailovic@northwestern.edu

References

Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. Epub 2005 Feb 4.

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Janicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32.

Machado S, Paes F, Velasques B, Teixeira S, Piedade R, Ribeiro P, Nardi AE, Arias-Carrión O. Is rTMS an effective therapeutic strategy that can be used to treat anxiety disorders? Neuropharmacology. 2012 Jan;62(1):125-34. Epub 2011 Jul 27. Review.

O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. Epub 2007 Jun 14.

Paes F, Machado S, Arias-Carrión O, Velasques B, Teixeira S, Budde H, Cagy M, Piedade R, Ribeiro P, Huston JP, Sack AT, Nardi AE. The value of repetitive transcranial magnetic stimulation (rTMS) for the treatment of anxiety disorders: an integrative review. CNS Neurol Disord Drug Targets. 2011 Aug;10(5):610-20. Review.

Schutter DJ. Antidepressant efficacy of high-frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham-controlled designs: a meta-analysis. Psychol Med. 2009 Jan;39(1):65-75. Epub 2008 Apr 30.

Slotema CW, Blom JD, Hoek HW, Sommer IE. Should we expand the toolbox of psychiatric treatment methods to include Repetitive Transcranial Magnetic Stimulation (rTMS)? A meta-analysis of the efficacy of rTMS in psychiatric disorders. J Clin Psychiatry. 2010 Jul;71(7):873-84. Epub 2010 Mar 9.

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