Repetitive Transcranial Magnetic Stimulation in Breast Cancer Patients with Depression and Anxiety
This pilot randomized clinical trial studies repetitive transcranial magnetic stimulation in treating depression and anxiety in breast cancer survivors. Repetitive transcranial magnetic stimulation may help improve depression and anxiety in breast cancer survivors.
Inclusion Criteria
- Had a previous diagnosis of breast cancer (any type or stage) as confirmed by official medical records
- Has a Diagnostic and Statistical Manual (DSM) IV diagnosis of Major Depressive Disorder
- Has a Hamilton Rating Scale for Depression (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 has any type of brain tumor
- 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 one 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01701284.
PRIMARY OBJECTIVES:
I. To test the safety and tolerability of left- and right-sided repetitive transcranial magnetic stimulation (rTMS) as a treatment for depression in breast cancer survivors.
II. To test the efficacy of left- and right-sided rTMS as a treatment for depression in breast cancer survivors.
III. To evaluate treatment parameters for the optimal antidepressant effects of rTMS in breast cancer survivors.
SECONDARY OBJECTIVES:
I. To evaluate how baseline co-morbid anxiety correlates with antidepressant efficacy of left- and right-sided rTMS protocols.
II. To evaluate the efficacy of left- and right-sided rTMS on co-morbid anxiety in breast cancer survivors with depression.
III. To evaluate treatment parameters for the optimal anxiolytic effects of rTMS in breast cancer survivors with co-morbid depression and anxiety.
IV. To determine how breast cancer survivors' anxiety correlates with harm avoidance personality traits.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo high-frequency repetitive transcranial magnetic stimulation to the left dorsolateral prefontal cortex (dlPFC) over 40 minutes 5 days a week for 6 weeks.
Arm II: Patients undergo low-frequency repetitive transcranial magnetic stimulation to the right dlPFC over 40 minutes 5 days a week for 6 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorMehmet Dokucu
- Primary IDNU 12CC12
- Secondary IDsNCI-2012-01691, STU00063218
- ClinicalTrials.gov IDNCT01701284