Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression
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| ClinicalTrials.gov Identifier: NCT01770600 |
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Recruitment Status :
Withdrawn
(never initiated, did different study)
First Posted : January 18, 2013
Last Update Posted : May 28, 2015
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Sponsor:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Cheryl McCullumsmith, University of Alabama at Birmingham
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Impulsivity Active Suicidal Ideation Depression | Other: placebo Drug: Riperidone | Not Applicable |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Assessment and Treatment of Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression. |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | September 2013 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
MedlinePlus related topics:
Suicide
Drug Information available for:
Risperidone
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Risperidone
Administer pill of risperidone 1 mg once a day by mouth for 5 days.
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Drug: Riperidone
1 mg risperidone administered orally for 5 days
Other Name: risperdal |
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Placebo Comparator: Placebo
Administer pill of placebo once a day by mouth for 5 days.
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Other: placebo
placebo pill administered daily for 5 days |
Primary Outcome Measures :
- Decrease in depression symptoms [ Time Frame: baseline to 5 days ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 19 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770600
Locations
| United States, Alabama | |
| University of Alabama Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
| Principal Investigator: | Cheryl B McCullumsmith, MD PhD | University of Alabama at Birmingham |
| Responsible Party: | Cheryl McCullumsmith, Division Director, Hospital Psychiatry, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01770600 History of Changes |
| Other Study ID Numbers: |
F1003310002 |
| First Posted: | January 18, 2013 Key Record Dates |
| Last Update Posted: | May 28, 2015 |
| Last Verified: | May 2015 |
Keywords provided by Cheryl McCullumsmith, University of Alabama at Birmingham:
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Age 19 to 64 Medically stable No current or history of psychosis No alcohol or benzodiazepine withdrawal |
Additional relevant MeSH terms:
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Depression Depressive Disorder Suicidal Ideation Impulsive Behavior Behavioral Symptoms Mood Disorders Mental Disorders Suicide Self-Injurious Behavior Risperidone Serotonin Antagonists |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents |