A Prospective, Single-Blinded, Randomized, Multicentre Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Subjects With a Primary Diagnosis of a Depressive Disorder
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
研究概览
简要总结
Improving the prescription accuracy of psychotropic medications for military personnel diagnosed with neuropsychiatric disorders is imperative to promote accelerated treatment response and recovery. This study will determine whether PEER (Psychiatric EEG Evaluation Registry) Interactive (a comparison of a quantitative electroencephalogram (QEEG) to an existing database of subject outcomes) provides an objective adjunctive tool that is more effective in guiding treatment than the current standard of practice in the treatment of military personnel suffering from non-psychotic mental illness. For this prospective, multicenter, randomized, single-blinded, controlled study, 100 participants with a primary diagnosis of a DSM-V depressive disorder, with comorbidity of non-psychotic behavioral disorders to include mild Traumatic Brain Injury (mTBI) and Post Traumatic Stress Disorder (PTSD), will be enrolled. Participants will be randomized into a control or experimental group, and all will undergo a quantitative electroencephalogram (QEEG). For the experimental group, research staff will receive an Outcome Report from PEER Interactive and will follow the guidance of the Report to inform treatment. For the control group, research staff will not receive a participant Outcome Report from PEER Interactive and these participants will be treated based on current standards. For the control group, Outcome Reports will be sequestered for post-hoc analysis. Research staff in collaboration with CNS Response (the Sponsor) will evaluate and validate if the guidance provided by PEER Interactive correlates with the predicted participant outcome. Research staff in collaboration with the Sponsor will also evaluate if the treatment guidance provided by PEER Interactive results in improved mental health and/or a reduction of risk as measured by a reduction in severe adverse events, including suicidality.
详细描述
Study Design
This is a prospective, single-blinded, randomized, multicenter study to evaluate the utility, safety, and efficacy of using PEER Interactive to inform the prescription of medications to participants with a primary diagnosis of a depressive disorder, with or without comorbidity of non-psychotic behavioral disorders, versus treatment as usual.
This study is observational in nature, in that the participants in the control group will be treated according to treatment as usual and best judgment of the treating clinician. The participants in the experimental group will be treated with adjunctive information provided by the PEER Interactive Report. It is a controlled study in that the schedule of visits, procedures and measurements will be defined by the protocol in order to provide consistent data for both the control and experimental groups.
Participants will be blinded as to presence/use of the PEER Interactive Report and will provide the primary efficacy outcome evaluation. All participants will be randomized into a control or experimental group. All participants will receive a quantitative electroencephalogram (QEEG). For those participants in the experimental group, the research staff will receive an Outcome Report from PEER Interactive. The clinician in the experimental group will use the PEER Interactive Report in the medication prescription process. For the control group, the research staff will not receive an Outcome Report. Outcome Reports for the control group will be sequestered for post-hoc analysis.
The research staff will incorporate the information provided by the Outcome Report from PEER Interactive in their prescription decisions. PEER Interactive provides adjunctive information to assist the treating clinician in the clinical decision process. For the experimental group the research staff is expected to follow the guidance of the subject's PEER Outcome Report as regards to the participant's responsiveness to the on-label medications noted in the Report. Although the study staff is strongly encouraged to use the guidance in the medication decision, prescription of medication is a clinical decision and will be made by the research staff. A decision to not follow the guidance of the Report should be documented and explained. In some cases, the Report may indicate sensitivity for a medication to which the subject has not been responsive in previous treatment - or - if effective for the diagnosed condition may cause/have caused an undesired side effect e.g. rash, nausea, etc. The clinician must always consider subject history in the treatment decision. We expect the Report will indicate that the participant will not be responsive to the previous treatment, and therefore, the treatment should not be prescribed. The PEER Report informs medication decisions as a part of treatment. If the only medication indicated by the report is a medication the participant has had poor experience with; the participant should be treated with another medication indicated as responsive by the Report. In the event the Report indicates the participant is not responsive to any of the on-label medications in the Report, the treating clinician may prescribe according to best clinical judgment. The research staff will note the basis for all medication decisions in the subject's treatment/study file. The only change to standard of care is the use of the PEER Report to inform medication decisions for the experimental group e.g. If a participant is receiving psychotherapy/ counseling along with medical therapy prior to enrollment, the participant will continue with all other therapies as usual.
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
- Single (Participant)
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
- •Male and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
- •Participants able to provide written informed consent to participate in the study.
- •Participants with a primary diagnosis of a DSM-V depressive disorder, including subjects with comorbidity of a non-psychotic behavioral disorder.
- •Participants with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study. mTBI will be defined according to best clinical practice guidelines. The subject should have experienced no more than 30 minutes of loss of consciousness, less than a 24 hour alteration in consciousness or mental status, less than 24 hours of post-traumatic amnesia and a Glasgow Coma Scale (best available score in the first 24 hours) of 13 or greater.
- •Participants with comorbidity of post-traumatic stress disorder (PTSD) are eligible for inclusion in this study. A score of 45 or greater on the PTSD Checklist Military/Civilian (PCL-M/C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as a comorbid condition.
- •Able to stop non-essential medications, including drugs of abuse, for 5 half-lives of the medication(s). See Appendix B for a list of the five half-life time periods for medications.
- •The potential subject's primary care physician may be consulted to make these determinations.
- •Able to be washed out of non-essential medications within 14 days, i.e. 5 half-lives are not longer than 14 days (See Appendix B).
- •Participants will be selected from patients on the psychiatric inpatient ward, partially hospitalized patients, and psychiatric outpatients.
- •Ability to comply with the requirements of the study.
排除标准
- •Male and female subject less than 18 years old or greater than 65 years old
- •Participants who cannot provide written informed consent
- •Diagnosis of a psychotic disorder.
- •History of, or current, open head brain trauma.
- •Subjects with comorbidity of mild traumatic brain injury (mTBI) or traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than
- •Participants who, in the opinion of the research staff or medical prescriber for non-psychotropic drugs (e.g., primary care, cardiovascular, etc.), would not be good candidates to be washed out of their medications and - in the case of outpatients - are unable to washout medications and/or supplements in a period of 14 days or less.
- •Participants currently prescribed Fluoxetine when assessed for study entry (due to long metabolite half-life).
- •History of: craniotomy, cerebral metastases, cerebrovascular accident; current diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
- •Clinically significant medical illness, including thyroid disorders, which cannot be remediated with medication, e.g. synthroid.
- •Participation in any other therapeutic drug study within 60 days preceding inclusion.
- •Known pregnancy and/or lactation, or intent to become pregnant during this study.
- •Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
- •Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
- •Candidates currently stable and considered to be at Maximum Medical Improvement (MMI) on current medications.
- •Participant has a positive urine drug screen.
- •Participant has active suicidal intent.
结局指标
主要结局
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
时间窗: Change from Baseline to 12 weeks to monitor change in depressive symptomatology.
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) is a 16-item depressive symptomatology self-report questionnaires which has been useful as a way of determining a patient's level of depression before, during, and after treatment. Questions are answered by checking off the most appropriate answer to describe how they have been feeling over the past 7 days and are scored between 0-3 points per question. Total score can range from 0-27 with higher values indicating worse outcomes (5 or lower: no depression, 6 to 10: mild depression, 11 to 15: moderate depression, 16 to 20: severe depression, 21 or higher: very severe depression). The QIDS is score as follows: Sum together the highest score out of Items 1-4, Item 5 score, highest score out of Items 6-9, sum Item 10, 11, 12, 13, and 14, highest score out of Items 15 and 16, sum all of these values for the final total score.
次要结局
未报告次要终点
研究者
Dr. Verner Knott
Director, Clinical Neuroelectrophysiology and Cognitive Research Laboratory
University of Ottawa