Back to resultsRisperidone and Suicidality in Major Depressive Disorder
Primary Purpose
Depression
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Risperidone and placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring suicidality, antipsychotic, antidepressant, treatment
Eligibility Criteria
Inclusion Criteria: 19-60 years of age Diagnosis of major depressive disorder, currently severe with suicidality A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/> 25 with the suicide sub-score =/> 4 Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks In good physical health Exclusion Criteria: Depression without suicidality Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder) Depressive symptoms induced by alcohol or substance abuse Psychotic features which are predominant at the initial evaluation Unstable major medical illness, such as cardiac disease or diabetes Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
risperidone
placebo
Arm Description
risperidone
placebo comparator
Outcomes
Primary Outcome Measures
CGI
Clinical Global Impression
Secondary Outcome Measures
MADRS
Montgomery Asberg Depression Rating Scale
Full Information
NCT ID
NCT00167154
First Posted
September 10, 2005
Last Updated
June 8, 2021
Sponsor
University of Alabama at Birmingham
Collaborators
Janssen Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00167154
Brief Title
Risperidone and Suicidality in Major Depressive Disorder
Official Title
Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Janssen Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder.
Detailed Description
Using a double blind, placebo-controlled design, subjects diagnosed with a current episode of major depressive disorder (defined by DSM-IV criteria and supported by the Mini International Neuropsychiatric Interview), severe with suicidality despite currently taking an antidepressant, will be enrolled in the eight-week study. The treatment will be initiated by randomizing patients to receive risperidone or placebo in addition to the antidepressant that the patient is already taking. The clinical efficacy will be evaluated after 4 days, weekly for 4 weeks, then every other week for 4 weeks with the efficacy measures. During the eight-week study, treatment with risperidone or placebo will continue at the highest effective dosage (up to 2 mg per day). The dose of the antidepressant will not be changed during the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
suicidality, antipsychotic, antidepressant, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
risperidone
Arm Type
Experimental
Arm Description
risperidone
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo comparator
Intervention Type
Drug
Intervention Name(s)
Risperidone and placebo comparator
Intervention Description
Up to 2 mg risperidone or matching placebo daily
Primary Outcome Measure Information:
Title
CGI
Description
Clinical Global Impression
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
MADRS
Description
Montgomery Asberg Depression Rating Scale
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
19-60 years of age
Diagnosis of major depressive disorder, currently severe with suicidality
A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/> 25 with the suicide sub-score =/> 4
Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks
In good physical health
Exclusion Criteria:
Depression without suicidality
Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder)
Depressive symptoms induced by alcohol or substance abuse
Psychotic features which are predominant at the initial evaluation
Unstable major medical illness, such as cardiac disease or diabetes
Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohua Li, MD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18681749
Citation
Reeves H, Batra S, May RS, Zhang R, Dahl DC, Li X. Efficacy of risperidone augmentation to antidepressants in the management of suicidality in major depressive disorder: a randomized, double-blind, placebo-controlled pilot study. J Clin Psychiatry. 2008 Aug;69(8):1228-1236. doi: 10.4088/jcp.v69n0805.
Results Reference
result
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Risperidone and Suicidality in Major Depressive Disorder
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