Track topics on Twitter Track topics that are important to you
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.
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.
Members of the control group will receive no study related medications and will not return for a follow up visit.
Information for Women of Childbearing Potential or Men Fathering a Child Because risperidone may affect mother's milk or a developing fetus, breast-feeding and pregnant women are not allowed to take part in the study. Women who can become pregnant must take a pregnancy test before the start of the study. Unless they cannot have children because of surgery or other medical reasons, men and women must have been using an effective method of birth control before starting the study. Effective birth control includes birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy.
Optional functional MRI(fMRI) brain Sub-study
10 participants will participate in the fMRI sub-study, which will include a 5 day open-label trial of risperidone. An fMRI scan will be done prior to receiving study drug and 5 days later. During this fMRI, a picture of your brain will be obtained. The fMRI procedure requires you to lie still on a narrow table with a circular scanner around your head. The fMRI scan takes approximately 40 minutes. Two of the neuropsychological assessments will be administered during the scan. Sub-study participants will complete a computer-based version of the tasks that will be performed during the fMRI scan prior to the brain imaging session. This is necessary to ensure you understand the tasks you will be performing while the imaging is taking place. Electing not to participate in this sub-study will not jeopardize participation in the drug trial. A neurologist, Dr. Lawrence Ver Hoef will review the MRI scans for incidental findings.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
University of Alabama Birmingham
University of Alabama at Birmingham
Published on BioPortfolio: 2014-08-27T04:00:40-0400
The purpose of the this study is to compare pathological gamblers versus non-pathological gamblers using tests that measure different components of impulsivity. We aim to invite a total o...
Impulsivity, a well-known risk factor predicting negative outcomes, refers broadly to a proclivity towards rapid action with a suboptimal regard for future consequences. Importantly, impul...
The study aims to examine a battery of behavioral and questionnaire measures in 4 disorders clinically associated with impulsivity and in health controls, to: 1) investigate if the differe...
As a first step toward investigating whether modulation of impulsivity and associated neural pathways may yield clinically meaningful changes in risk for adolescent suicidal behavior, the ...
The primary purpose of this study is to investigate the effect of lorcaserin on reductions in cannabis use and multiple constructs of impulsivity in outpatient treatment-seeking individual...
Impulsivity is regarded as a multifaceted construct that comprises two dimensions: rapid-response impulsivity and reward-delay impulsivity. It is unclear, however, which aspects of trait impulsivity, ...
Impulsivity and compulsivity are transdiagnostic features associated with clinically relevant aspects of psychiatric disorders, including addictions. However, little research has investigated how impu...
Impulsivity is strongly associated with substance use disorders (SUDs). Our review discusses impulsivity as an underlying vulnerability marker for SUDs, and treatment of co-occurring impulsivity in SU...
Impulsivity, broadly characterized as the tendency to act prematurely without foresight, is linked to alcohol misuse in college students. However, impulsivity is a multidimensional construct and diffe...
Gambling disorder (GD) is a highly heterogeneous condition with high rates of chronicity, relapses and treatment dropout. The aim of this study was to longitudinally explore the associations between t...
A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-IV)
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A personality disorder marked by a pattern of instability of interpersonal relationships, self-image, and affects, and marked impulsivity beginning by early adulthood and present in a variety of contexts. (DSM-IV)
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...