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

NCT01770600 | Withdrawn

• 1 other identifier: F1003310002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Impulsivity; Active Suicidal Ideation; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Decrease in depression symptoms

  baseline to 5 days

Study Arms (2)

Risperidone

ACTIVE COMPARATOR

Administer pill of risperidone 1 mg once a day by mouth for 5 days.

Drug: Riperidone

Placebo

PLACEBO COMPARATOR

Administer pill of placebo once a day by mouth for 5 days.

Other: placebo

Interventions

placebo OTHER

placebo pill administered daily for 5 days

Placebo

Riperidone DRUG

1 mg risperidone administered orally for 5 days

Also known as: risperdal

Risperidone

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age : 19-64
• Suicidality score of \> 4 on Montgomery-Asberg Depression Rating Scale (MADRS)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Impulsive Behavior; Depression

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cheryl B McCullumsmith, MD PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director, Hospital Psychiatry

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: January 18, 2013
• Study Start: April 1, 2010
• Primary Completion: September 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)