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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


N/A
22 Years
70 Years
Open (Enrolling)
Female
Breast Cancer in Remission, Depression, Anxiety

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall change in depression severity

Outcome Description:

Overall change in depression severity (as measured by the Hamilton Depression Rating Scale) will be measured for each treatment arm.

Outcome Time Frame:

0, 2, 4, and 6 weeks

Safety Issue:

No

Principal Investigator

Mehmet Dokucu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU 12CC12

NCT ID:

NCT01701284

Start Date:

December 2012

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer in Remission
  • Depression
  • Anxiety
  • repetitive Transcranial Magnetic Stimulation
  • Breast Cancer Survivor
  • Depression
  • Anxiety
  • Anxiety Disorders
  • Breast Neoplasms
  • Depression
  • Depressive Disorder

Name

Location

Northwestern UniversityChicago, Illinois  60611