Neuromodulation Device Use in Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Depression
研究概览
简要总结
Study the neuromodulation device in the treatment of Major Depressive Disorder and associated symptoms.
In this study we use the Hamilton Depression Rating Scale (HAM-D), the Quality of Life Scale (QQLS), the Rumination Response Scale (RRS), the Brief Irritability Test (BIT), the Generalized Anxiety Disorder 7 Item Scale (GAD 7), and the Future Orientation Scale (FOS). This study was designed to mirror real life situations, and thus patients are not asked to stop their pharmaceutical treatments.
Primary hypothesis for this study is:
o Daily use of the device will decrease depressive symptoms as measured by HAM-D.
Secondary hypotheses for these study are:
- Daily use of the device will increase quality of life as measured by the QQLS.
- Daily use of the device will decrease rumination as measured by the RRS.
- Daily use of the device will decrease irritability as measured by the BIT.
- Daily use of the device will increase future orientation as measured by the FOS.
- Daily use of the device will decrease anxiety as measured by the GAD-7.
详细描述
Experimental design 1. This study will be a randomized clinical trial to assess the effects of the device on depression as well as ancillary symptoms of depression. The study will involve 2 phases: Screening/Baseline and Treatment. In the screening phase patients will be assessed by clinical psychiatrists for depression using the Diagnostics and Statistics Manuel 5 (DSM-5) criteria. Baseline rates of depression, quality of life, rumination, irritability, anxiety and future orientation will be gathered prior to treatment. These metrics will be measured by HAM-D, QQLS, RRS, BIT, GAD-7, and FOS respectively. Patients will then be randomized to either the treatment group or the control group. Control group patients will be assigned sham devices by an investigator that is not involved in measurement. On Day 1, patients will be instructed on the use of the Device and will apply the device for the first time under clinic supervision; all other uses of the device will be conducted at home. During the treatment phase, patients will undergo 2 16 minute session of device treatment per day for 8 weeks. Recommended sessions occur once during the day and once before bed. Metrics described above will be measured at the end of week 2 (day 14), week 4 (day 28), week 6 (day 42), and week 8 (day 56). Adverse effects will be assessed at each of these junctures. Patient will return the device on day 56 or at time of discontinuation. Patients who choose to discontinue the study will have their last recorder measures carried forward. In an effort to increase external validity patients will not be asked to change their current treatment plan as outlined by their outpatient psychiatrist. Patients will may continue previously prescribed medication, but no medication changes will occur during the trial.
STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE
- Statistical and Analytical Plans
a. Before database lock, a statistical analysis plan (SAP) will be authored as a separate document and approved by the investigative team. The SAP will provide a more detailed description of the methods for the analyses described as follows. Any deviations from the planned analyses will be described and justified in the final study report. All study data will be presented in data listings by subject number and time point (where applicable). Summary tables will be presented by time point (where applicable). 2. Analysis Populations
- A single set of all completed participants will be analyzed for the primary and secondary outcomes. Additional analyses may be performed on a case-by-case basis using descriptive techniques to enumerate and characterize any patients found to have experienced an Adverse Event (AE) during the trial. Any adjustments to the analysis populations will be based on procedures outlined in the SAP or modifications to the SAP, and also described in the final study report.
- Disposition of Patients
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
a. will provide randomized devices and give study staff a list of device ID numbers to assign in order. Study investigators will have no knowledge of which device is a sham device. will keep blinding information on a separate locked external hard drive that investigators will not have access to. Data attached to each device ID will sent to 's analytics team for statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingly provides written informed consent prior to the conduct of any study-related procedures.
- •Male or female, 18 to 65 years of age, inclusive.
- •Clinical diagnosis of Major Depressive Disorder.
- •Patient must be in generally good health based upon the results of a medical history, physical examination, and vital signs, at the investigator's discretion.
- •Willing and able to comply with the study requirements, complete study assessments, and visit the clinic at the scheduled times for the duration of the Treatment Phase.
- •Able to understand, speak and read English sufficient for the completion of study assessments.
排除标准
- •Pregnant (verbal patient report only) or lactating.
- •History or presence of photo-sensitive epilepsy or other photo-sensitive conditions.
- •History or presence of condition(s) that may affect balance, such as seizure disorders or vertigo
- •History or presence of migraine, at the investigator's discretion
- •Vision impairments that affect perception of light, color, or brightness in one or both eyes, or differences in visual perception between eyes.
- •Deafness in one or both ears, perceived differences in hearing between ears or tinnitus.
- •Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion).
- •Presence of inflammation or broken skin around the eyes in the area of the mask.
- •Participating in any other clinical study in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days.
- •Any pending legal action that could prohibit participation or compliance in the study.
- •Any psychiatric diagnosis that would preclude competency to consent to participation.
- •Significant medical conditions or other circumstances which, in the opinion of the investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the patient from safely participating in study.
- •Employee of the investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the investigator or study site, or a family member of an employee or of the investigator.
结局指标
主要结局
Depression
时间窗: 8 weeks
Decrease in depressive symptoms as measured by the Hamilton Depression Rating Scale, rated between 0-54, with higher numbers indicated more depression.
次要结局
未报告次要终点
研究者
Ari Aal
Primary Investigator
Medical Center of Aurora