A Randomized Open-Label Pilot Trial To Evaluate The Safety And Efficacy Of Repetitive Transcranial Magnetic Stimulation In Cancer Patients With Depression And Anxiety
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer in Remission (Any Type or Stage)
- Sponsor
- Northwestern University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Overall change in depression severity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Mehmet Dokucu
Assistant Professor of Psychiatry
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Overall change in depression severity
Time Frame: 0, 2, 4, and 6 weeks
Overall change in depression severity (as measured by the Hamilton Depression Rating Scale) will be measured for each treatment arm.
Relative change in depression severity
Time Frame: 0, 2, 4, and 6 weeks
Change in depression severity (as measured by the Hamilton Depression Rating Scale) for a treatment arm will be compared relative to change in depression severity in the other treatment arm.
Presence and changes in severity of side effects
Time Frame: 0, 2, 4, and 6 weeks
At weeks 2, 4 and 6, UKU Side Effects Rating Scale scores will be compared to baseline UKU scores to determine changes in presence and severity of side effects. Additionally, UKU scores at weeks 2, 4, and 6 will be used to determine probability that side effects are related to intervention.
Secondary Outcomes
- Relative change in anxiety severity(Weekly (starting with week 0 through week 6))
- Correlation of anxiety with change in depression severity(0 and 6 weeks)
- Overall change in anxiety severity(Weekly (starting with week 0 through week 6))
- Correlation of anxiety with harm avoidance personality trait(Baseline)