A Prospective, Double Blind, Randomized, Multicenter Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Patients With a Primary Diagnosis of a Depressive Disorder Versus Treatment as Usual.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 1,922
- 试验地点
- 4
- 主要终点
- Quick Inventory of Depressive Symptomatology - Self Reported 16 (QIDS-SR16)
研究概览
简要总结
This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate the effectiveness of PEER Interactive to inform treatment in subjects with a primary diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus treatment as usual, as determined by the investigator. The primary measurement for improvement of the subjects depression will be a self-evaluation questionnaire, Quick Inventory of Depressive Symptomatology-Self Report 16, but the investigators will also collect information on their clinical global improvement and any reduction in adverse events.
详细描述
This study is prospective in nature. Subjects in the control group will be treated according to treatment as usual and best judgment of the treating physician. For the experimental group the treating physician will follow the guidance of the subject's PEER Interactive Report as regards sensitivity to on-label medications and classes of medication.
The subjects will be washed out of all current medications prior to having an EEG, which is necessary to generate the PEER Interactive Report. The wash out period for outpatients is no longer than 14 days.
The subjects will be followed for 6 months after the initial treatment, or until the patient has achieved maximum medical improvement (MMI). The patient will be seen on a routine basis and assessments will be made at each interaction to evaluate the patient's improvement in mental health. The subjects will also be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The investigator is allowed to treat the patient according to their best medical judgment, which may include adding or changing medications, seeing the patient more frequently, or other interventions such as the use of sleep aids.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The subject is masked as to assignment to Control or Treatment Group.
The blinded subject acts as the blinded rater in providing the primary outcome measure of the QIDS-SR16
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
- 否
入选标准
- •Must speak and read English
- •Must be able to provide written informed consent
- •A primary diagnosis of a DSM-IV depressive disorder
- •Co-morbidities of non-psychotic behavioral disorders, including PTSD and mild Traumatic Brain Injury (mTBI) are eligible to participate.
- •Able to stop all medications (wash out) for 5 half-lves of all medication(s) which affect the EEG. Outpatient subjects are eligible if they can be washed out of their medications in 14 days or less.
- •Ability to comply with the requirements of the study
排除标准
- •Diagnosis of a psychotic disorder
- •History of, or current, open head trauma
- •Subjects who would not be good candidates to be washed out of their medications, in the opinion of the investigator.
- •History of craniotomy, cerebral metastases, cerebrovascular accident, current diagnosis of seizure disorder, bipolar disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features, or use of depot neuroleptics in the last 12 months.
- •Clinically significant medical illness, including thyroid disorders.
- •Participation in any other therapeutic drug study within 60 days preceding inclusion in the study.
- •Know pregnancy and/or lactation, or intent to become pregnant during the study.
- •Chronic or acute pain requiring prescription medication(s).
- •Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG
- •Candidates that are currently stable and considered to be at maximum medical improvement on current medications.
结局指标
主要结局
Quick Inventory of Depressive Symptomatology - Self Reported 16 (QIDS-SR16)
时间窗: 6 months
A 16 question self administer survey on the status of the subject's depression. The measurement will be taken until the completion of the study (6 months)or until the subject achieves maximum medical improvement.
次要结局
- Clinical Global Impression (CGI)(6 months)
- Concise Health Risk Tracking (CHRT-7SR)(6 months)
- Post traumatic stress disorder checklist - civilian(6 months)
- Maximum Medical Improvement (MMI)(6 months)