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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01770600
First received: August 7, 2012
Last updated: October 24, 2014
Last verified: January 2013
  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
Thought Process Disorder
Active Suicidal Ideation
Depression
Other: placebo
Drug: Riperidone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 University of Alabama at Birmingham:

Primary Outcome Measures:
  • Decrease in depression symptoms [ Time Frame: baseline to 5 days ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2010
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Risperidone
Receipt of 1-2 mg/day for 5 days
Drug: Riperidone
Placebo Comparator: Placebo
Matching placebo once a day by mouth for 5 days.
Other: placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years
Genders Eligible for Study:   Both
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
  More Information

No publications provided

Responsible Party: 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: October 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Disease
Impulsive Behavior
Suicidal Ideation
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Self-Injurious Behavior
Suicide

ClinicalTrials.gov processed this record on October 30, 2014