NCT00167154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 depression

Timeline
Completed

Started Jun 2004

Typical duration for phase_3 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

2.8 years

First QC Date

September 10, 2005

Last Update Submit

June 8, 2021

Conditions

Depression

Keywords

suicidalityantipsychoticantidepressanttreatment

Outcome Measures

Primary Outcomes (1)

  • CGI

    Clinical Global Impression

    8 weeks

Secondary Outcomes (1)

  • MADRS

    8 weeks

Study Arms (2)

risperidone

EXPERIMENTAL

risperidone

Drug: Risperidone and placebo comparator

placebo

PLACEBO COMPARATOR

placebo comparator

Drug: Risperidone and placebo comparator

Interventions

Risperidone and placebo comparatorDRUG

Up to 2 mg risperidone or matching placebo daily

placeborisperidone

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 18681749RESULT

MeSH Terms

Conditions

DepressionSuicidal Ideation

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSelf-Injurious Behavior

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Xiaohua Li, MD, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 14, 2005

Study Start

June 1, 2004

Primary Completion

April 1, 2007

Study Completion

August 1, 2008

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

US(1)