A Study of the Effectiveness and Safety of Risperidone to Augment SSRI Therapy in Patients With Treatment-resistant Depression
A Study to Evaluate the Efficacy, Safety and Maintenance Effect of Risperidone Augmentation of SSRI Monotherapy in Young and Older Adult Patients With Unipolar Treatment-Resistant Depression
1 other identifier
interventional
258
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of risperidone to augment SSRI therapy in patients with treatment-resistant depression and to demonstrate the long-term maintenance effect of risperidone as augmentation therapy compared with placebo augmentation in these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2002
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2002
CompletedFirst Posted
Study publicly available on registry
September 5, 2002
CompletedStudy Start
First participant enrolled
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedMay 18, 2011
November 1, 2010
September 3, 2002
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at end of treatment; time to relapse
Secondary Outcomes (1)
Response rate, determined from >=50% improvement from baseline at MADRS total score; change from baseline in Hamilton Rating Scale of Depression (HAM-D) and Clinical Global Impression (CGI) scale; incidence of adverse events throughout study.
Interventions
Eligibility Criteria
You may qualify if:
- Meet criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV), for Major Depressive Disorder
- history of resistance to therapy with antidepressant medication
- score on the Hamilton Rating Scale of Depression (HAM-D) of \>=20 at start of study.
You may not qualify if:
- Meet DSM-IV criteria for Axis I disorder (except anxiety disorders) or borderline personality disorder
- substance dependence, including drugs of abuse and alcohol
- history of schizophrenia, bipolar disorder, or manic episode
- meet DSM-IV criteria for delirium, dementia, amnesic or other cognitive disorder supported by Mini Mental Status Examination (MMSE)
- pregnant or nursing females, or those lacking adequate contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 3, 2002
First Posted
September 5, 2002
Study Start
October 1, 2002
Study Completion
March 1, 2004
Last Updated
May 18, 2011
Record last verified: 2010-11