Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Breast Cancer, Depression |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 22 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | December 2012 |
| End Date: | August 2018 |
| Contact: | Marko Mihailovic |
| Email: | marko.mihailovic@northwestern.edu |
| Phone: | (312) 503-9096 |
A RANDOMIZED OPEN-LABEL PILOT TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN 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.
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.
Inclusion Criteria:
- Female
- Age 22-70
- Had a previous diagnosis of 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.
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Mehmet Dokucu, MD, PhD
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