A Randomized Open-Label Pilot Trial To Evaluate The Safety And Efficacy Of Repetitive Transcranial Magnetic Stimulation In Cancer Patients With Depression And Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults aged 22-80;
- •Have a previous diagnosis of cancer (any type or stage) as confirmed by official medical records;
- •Have a Diagnostic and Statistical Manual (DSM-IV) diagnosis of Major Depressive Disorder;
- •Have a Hamilton Depression Rating (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.
排除标准
- •1. Participant with any type of brain tumor;
- •Participant with cancer with brain metastases;
- •Evidence of the disease at the time of entry into the trial;
- •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;
- •Participant had recent surgery within two weeks of screening;
- •Participants undergoing chemotherapy;
- •Participant pregnant or nursing;
- •Participant with any metallic object in or around their head;
- •Participant with a pacemaker;
- •Participants with unstable suicidal ideation as determined by the patient's treating psychiatrist;
- •Participants with a substance use disorder within the prior six months;
- •Significant history of head injury/trauma as defined by loss of consciousness for more than one 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 evaluated the drugs and doses to determine the risks and benefits. These were then discussed with the individual's Primary Care Physician to determine if the individual could be included in the study.
研究组 & 干预措施
Right-Sided Low-Frequency rTMS
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.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Left-Sided High-Frequency rTMS
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.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6
时间窗: Baseline (Week 0), Week 2, Week 4 and Week 6.
This measure reports the overall change in depression severity(HDRS-17) from baseline (Week 0) at each follow-up assessment. Overall Change is defined as the score at each subsequent time point minus the score at Baseline. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome. Calculation Logic: The values reported are the absolute difference of outcomes for each treatment arm. For each participant, the relative change is calculated as: Score at Visit - Baseline Score. Negative numbers indicates a reduction in symptom severity (improvement) and a positive number indicates worsening in symptom severity
Relative Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6
时间窗: Baseline (Week 0), Week 2, Week 4 and Week 6
Measure Description: This measure reports the relative (percentage) change in depression severity from baseline (Week 0) at each follow-up assessment. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome. Calculation Logic: The values reported are the mean percentage changes for each treatment arm. For each participant, the relative change is calculated as: ((Score at Visit - Baseline Score) / Baseline Score) \* 100. A negative percentage indicates a reduction in symptom severity (improvement).
Number of Participants With Treatment-Emergent Side Effects (UKU)
时间窗: Baseline (Week 0), Week 2, Week 4, and Week 6
Side effects assessed at Weeks 2, 4, 6 via Udvalg for Kliniske Undersøgelser (UKU) scale (48 items, 0=none to 3=severe; higher=worse). 'Treatment-emergent' worsening is a score increase ≥1 from baseline (Tx #1) on any item with possible/probable relation to intervention. Data reported is the count of participants meeting criteria for any of the clusters. Psychic Cluster: concentration, asthenia, sedation, memory, depression, unrest, sleep/dream changes, emotional indifference. Neurological Cluster: dystonia, rigidity, hypokinesia, hyperkinesia, tremor, akathisia, seizures, paresthesia, headache. Autonomic Cluster: accommodation, salivation, nausea/vomiting, diarrhea, constipation, micturition, polyuria, dizziness, tachycardia, sweating. Other Cluster: rash, pruritus, photosensitivity, weight change, menses changes, galactorrhea, gynecomastia, libido changes, erectile dysfunction.
次要结局
- Overall Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6(Baseline (Week 0), Week 1- Week 6 (Weekly assessments))
- Relative Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6(Baseline(Week 0), Week 1- Week 6 (Weekly assessments))
- Correlation Between Baseline Anxiety (HAM-A) and Change in Depression Severity (HDRS-17, HAM-D)(Baseline (Week 0) and Week 6)
- Correlation Between Baseline Anxiety (HAM-A) and Harm Avoidance (TCI-R)(Baseline)
研究者
Mehmet Dokucu
Assistant Professor of Psychiatry
Northwestern University