Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression

This study has been withdrawn prior to enrollment.

(never initiated, did different study)

Sponsor:

Information provided by (Responsible Party):

Cheryl McCullumsmith, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT01770600

First received: August 7, 2012

Last updated: May 26, 2015

Last verified: May 2015

History of Changes

Purpose

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	Intervention
Impulsivity Active Suicidal Ideation Depression	Other: placebo Drug: Riperidone


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
Official Title:	Assessment and Treatment of Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression.

Resource links provided by NLM:

MedlinePlus related topics: Suicide

Drug Information available for: Risperidone

U.S. FDA Resources

Further study details as provided by Cheryl McCullumsmith, University of Alabama at Birmingham:

Primary Outcome Measures:

Decrease in depression symptoms [ Time Frame: baseline to 5 days ]


Enrollment:	0
Study Start Date:	April 2010
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Risperidone Administer pill of risperidone 1 mg once a day by mouth for 5 days.	Drug: Riperidone 1 mg risperidone administered orally for 5 days Other Name: risperdal
Placebo Comparator: Placebo Administer pill of placebo once a day by mouth for 5 days.	Other: placebo placebo pill administered daily for 5 days

Show Detailed Description

Eligibility


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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information


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
Study First Received:	August 7, 2012
Last Updated:	May 26, 2015

Keywords provided by Cheryl McCullumsmith, University of Alabama at Birmingham:


Age 19 to 64 Medically stable No current or history of psychosis No alcohol or benzodiazepine withdrawal

Additional relevant MeSH terms:


Depression Depressive Disorder Impulsive Behavior Suicidal Ideation 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

ClinicalTrials.gov processed this record on May 25, 2017

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