- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770600
Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression
Assessment and Treatment of Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age : 19-64
- Suicidality score of > 4 on Montgomery-Asberg Depression Rating Scale (MADRS)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Risperidone
Administer pill of risperidone 1 mg once a day by mouth for 5 days.
|
1 mg risperidone administered orally for 5 days
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Administer pill of placebo once a day by mouth for 5 days.
|
placebo pill administered daily for 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in depression symptoms
Time Frame: baseline to 5 days
|
baseline to 5 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Self-Injurious Behavior
- Suicide
- Depression
- Depressive Disorder
- Suicidal Ideation
- Impulsive Behavior
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- F1003310002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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