Clinical Trial: Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Assessment and Treatment of Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression.
Brief Summary: 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.
Detailed Summary:
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
Sponsor: University of Alabama at Birmingham
Current Primary Outcome: Decrease in depression symptoms [ Time Frame: baseline to 5 days ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Alabama at Birmingham
Dates:
Date Received: August 7, 2012
Date Started: April 2010
Date Completion:
Last Updated: May 26, 2015
Last Verified: May 2015
