Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01770600
Recruitment Status : Withdrawn (never initiated, did different study)
First Posted : January 18, 2013
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Cheryl McCullumsmith, University of Alabama at Birmingham

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 Show detailed description

Layout table for study information
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

MedlinePlus related topics: Suicide
Drug Information available for: Risperidone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01770600

Layout table for location information
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Layout table for investigator information
Principal Investigator: Cheryl B McCullumsmith, MD PhD University of Alabama at Birmingham
Layout table for additonal information
Responsible Party: Cheryl McCullumsmith, Division Director, Hospital Psychiatry, University of Alabama at Birmingham Identifier: NCT01770600    
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:
Age 19 to 64
Medically stable
No current or history of psychosis
No alcohol or benzodiazepine withdrawal
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Suicidal Ideation
Impulsive Behavior
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior
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