Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety (NCT01701284) | Clinical Trial Compass
CompletedNot Applicable
Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety
United States24 participantsStarted 2012-12
Plain-language summary
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.
Who can participate
Age range
22 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
1\. Adults aged 22-80; 2. Have a previous diagnosis of cancer (any type or stage) as confirmed by official medical records; 3. Have a Diagnostic and Statistical Manual (DSM-IV) diagnosis of Major Depressive Disorder; 4. Have a Hamilton Depression Rating (HAM-D) 24-item score of more than 20; 5. Failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current depressive episode; 6. All participants must have given signed, informed consent prior to registration in study.
Exclusion Criteria:
1\. Participant with any type of brain tumor; 2. Participant with cancer with brain metastases; 3. Evidence of the disease at the time of entry into the trial; 4. Presence or recent history of other concurrent cancers, with the following exceptions: a. Participants with completely treated basal or squamous skin cancers could be included in the study if their physicians deem that they are medically stable, b. Participants with completely treated in situ carcinoma of the breast or cervix could be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable, c. Participants with pre-cancerous lesions in the colon could be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable; 5. Participant had recent surgery within two weeks of screen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6