Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety (rTMSinCP)

Northwestern University

Status: Completed

Conditions: Cancer in Remission (Any Type or Stage); Depression; Anxiety

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01701284

NCI-2012-01691 (Registry Identifier)

NU 12CC12

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• Age 22-80
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Right-Sided Low-Frequency rTMS

Experimental group

Description:

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Left-Sided High-Frequency rTMS

Experimental group

Description:

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)