Assessment and Treatment of Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Decrease in depression symptoms
研究概览
简要总结
This study is dedicated to achieving a better understanding of how the brain processes information. Specifically, the investigators are studying cognitive function, thought process, and impulsivity in people with and without suicidal thoughts. You are being asked to participate in a research study to learn how the use of a medication, risperidone, improves your symptoms of depression. Specifically the investigators are studying the effectiveness of reducing the thought of suicide and other symptoms of severe depression. Risperidone is approved by FDA for the treatment of schizophrenia and bipolar mania, and clinical practice suggests that it might benefit patients with major depressive disorder. During clinical trials with 2607 patients, risperidone was proved to be safe. This is a pilot study to test a new indication of risperidone for treatment of severe depression. The study medication will be given in addition to usual psychiatric care.
详细描述
Men and women between the ages of 19-64, who have a diagnosis of major depressive disorder, and are currently in a severe depressive episode with suicidal thoughts, are eligible to participate in this voluntary research study. A control group will consist of men and women between the ages of 19-64 who have a diagnosis or major depressive disorder and are currently in a severe depressive episode but are not having suicidal thoughts.
During the screening visit, appropriate demographic, medical, and psychiatric data will be collected, including a diagnostic assessment and an assessment of the severity of your depression. You will be asked to complete several pen and pencil questionnaires to learn more about your current state of mind. This evaluation will take approximately two hours. If you qualify for the control or assessment group, you will be asked to meet with researchers again at 2, 4 and 6 days after your initial evaluation. If you qualify for the study group, you will be randomly (like the flip of a coin) assigned by a computer to receive either risperidone (1-2 mg/day) or placebo once a day by mouth. You will take the study medication for 5 nights in addition to your standard of care antidepressant prescribed by your doctor.
Forty participants will enter a double-blind study, which means that neither you nor your doctors will know which study medicine (risperidone or placebo) you are receiving. If medically necessary, the medication information will be released so your doctor can find out what medicine you were randomly assigned to.
You will have a follow-up evaluation (either in the hospital or returning for an office visit) at Day 5. At this visit, you will be evaluated by a psychiatrist and will be asked to complete questionnaires designed to assess the effect of the study medications on your symptoms. At this visit you will also be asked about possible side effects and how you are tolerating the medicine. These visits should take approximately one hour each.
At the screening and the end of the five day treatment, additional neuropsychological evaluations will be administered to assess your progress. These additional assessments will take approximately one hour to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 19-64
- •Suicidality score of > 4 on Montgomery-Asberg Depression Rating Scale (MADRS)
排除标准
- •pregnant,
- •medically unstable,
- •history of schizophrenia,
- •schizoaffective disorder,
- •bipolar disorder,
- •psychosis NOS,
- •urine drug screen positive for cocaine,
- •marijuana or amphetamines,
- •withdrawal from opiates,
- •benzodiazepines or alcohol,
- •currently on antipsychotic drug therapy. Also excluded are those subjects who require the use of mood stabilizers or antipsychotics.
研究组 & 干预措施
Risperidone
Administer pill of risperidone 1 mg once a day by mouth for 5 days.
干预措施: Riperidone (Drug)
Placebo
Administer pill of placebo once a day by mouth for 5 days.
干预措施: placebo (Other)
结局指标
主要结局
Decrease in depression symptoms
时间窗: baseline to 5 days
次要结局
未报告次要终点
研究者
Cheryl McCullumsmith
Division Director, Hospital Psychiatry
University of Alabama at Birmingham