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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01770600
First Posted: January 18, 2013
Last Update Posted: May 28, 2015
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.
Information provided by (Responsible Party):
Cheryl McCullumsmith, University of Alabama at Birmingham
  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 (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:


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

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.
  Contacts and Locations
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
  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
First Submitted: August 7, 2012
First Posted: January 18, 2013
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:
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