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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Collaborator:
Neuronetics
Information provided by (Responsible Party):
Mehmet Dokucu, Northwestern University
ClinicalTrials.gov Identifier:
NCT01701284
First received: October 3, 2012
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Breast Cancer in Remission
Depression
Anxiety
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Overall change in depression severity [ Time Frame: 0, 2, 4, and 6 weeks ] [ Designated as safety issue: No ]
    Overall change in depression severity (as measured by the Hamilton Depression Rating Scale) will be measured for each treatment arm.

  • Relative change in depression severity [ Time Frame: 0, 2, 4, and 6 weeks ] [ Designated as safety issue: No ]
    Change in depression severity (as measured by the Hamilton Depression Rating Scale) for a treatment arm will be compared relative to change in depression severity in the other treatment arm.

  • Presence and changes in severity of side effects [ Time Frame: 0, 2, 4, and 6 weeks ] [ Designated as safety issue: Yes ]
    At weeks 2, 4 and 6, UKU Side Effects Rating Scale scores will be compared to baseline UKU scores to determine changes in presence and severity of side effects. Additionally, UKU scores at weeks 2, 4, and 6 will be used to determine probability that side effects are related to intervention.


Secondary Outcome Measures:
  • Overall change in anxiety severity [ Time Frame: Weekly (starting with week 0 through week 6) ] [ Designated as safety issue: No ]
    Overall change in anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be measured for each treatment arm.

  • Relative change in anxiety severity [ Time Frame: Weekly (starting with week 0 through week 6) ] [ Designated as safety issue: No ]
    Change in anxiety severity (as measured by the Hamilton Anxiety Rating Scale) for a treatment arm will be compared relative to change in anxiety severity in the other treatment arm.

  • Correlation of anxiety with change in depression severity [ Time Frame: 0 and 6 weeks ] [ Designated as safety issue: No ]
    Baseline anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be correlated with change (from baseline to end of week 6) in depression severity (as measured by the Hamilton Depression Rating Scale) for each treatment arm and compared.

  • Correlation of anxiety with harm avoidance personality trait [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Baseline anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be correlated with Harm Avoidance scores from the TCI personality inventory


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Other Name: Neurostar TMS Therapy(R) System
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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Other Name: Neurostar TMS Therapy(R) System

  Eligibility

Ages Eligible for Study:   22 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701284

Contacts
Contact: Marko Mihailovic (312) 503-9096 marko.mihailovic@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Mehmet Dokucu, MD, PhD         
Sponsors and Collaborators
Northwestern University
Neuronetics
Investigators
Principal Investigator: Mehmet Dokucu, MD, PhD Northwestern University
  More Information

Publications:

Responsible Party: Mehmet Dokucu, Assistant Professor of Psychiatry, Northwestern University
ClinicalTrials.gov Identifier: NCT01701284     History of Changes
Other Study ID Numbers: NU 12CC12, NCI-2012-01691
Study First Received: October 3, 2012
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
repetitive Transcranial Magnetic Stimulation
Breast Cancer Survivor
Depression
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Depression
Depressive Disorder
Behavioral Symptoms
Breast Diseases
Mental Disorders
Mood Disorders
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014