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A Study of the Effectiveness and Safety of Risperidone to Augment SSRI Therapy in Patients With Treatment-resistant Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044681
First Posted: September 5, 2002
Last Update Posted: May 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen, LP
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
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.

Condition Intervention Phase
Depressive Disorder Depressive Disorder, Major Depression Drug: risperidone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at end of treatment; time to relapse

Secondary Outcome Measures:
  • 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.

Enrollment: 258
Study Start Date: October 2002
Study Completion Date: March 2004
Detailed Description:
Treatment strategies for treatment-resistant depression (TRD) involve either switching to another antidepressant, augmenting the first-line treatment with various pharmacologic agents, or switching to a different medication in combination with another agent. This study includes 2 phases: an open-label treatment phase and a double-blind maintenance phase, during which neither the patient nor the physician knows whether risperidone or placebo is administered. The open-label phase has an initial period of 6 weeks during which patients with TRD receive only citalopram, a selective serotonin reuptake inhibitor (SSRI). Risperidone is then added to the treatment regimen for 4 weeks to evaluate its short-term effect in augmenting the therapy. The double-blind phase last for 6 months and evaluates the relapse prevention of continued risperidone augmentation therapy compared with placebo augmentation of the SSRI. Targeted daily doses of citalopram and risperidone are adjusted for younger adults (18 to 54 years of age) and older adults (55 to 85 years of age). Assessments of effectiveness include the Montgomery-Asberg Depression Rating Scale (MADRS); Hamilton Rating Scale of Depression (HAM-D); Clinical Global Impression of Severity (CGI-S); response rate, determined by the proportion of patients showing >=50% improvement on MADRS total score; and relapse, evaluated by changes in CGI or HAM-D scores. Safety evaluations include the incidence of adverse events throughout the study, vital signs (pulse and blood pressure) and weight, and clinical laboratory tests (hematology, biochemistry, urinalysis) at specified intervals. The study hypothesis is that risperidone augmentation of SSRI therapy will show significant improvement in symptoms of depression compared with SSRI monotherapy and that risperidone augmentation will show better time-to-relapse than placebo augmentation in patients with TRD. Once daily, oral tablets of risperidone (0.25 milligram[mg], 0.5mg, 1.0mg, and 2.0mg), citalopram (20mg and 40mg) or placebo. Risperidone for 30 weeks; 0.25-2.0mg for younger adults, 0.25-1.0mg for older adults. Citalopram for 36 weeks; 20-60 mg for younger adults; 20-40 mg for older adults.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044681


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Janssen, LP
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00044681     History of Changes
Other Study ID Numbers: CR002143
First Submitted: September 3, 2002
First Posted: September 5, 2002
Last Update Posted: May 18, 2011
Last Verified: November 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Risperidone
depression
melancholia
depressive disorder
antipsychotic agents

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Depressive Disorder, Major
Disease
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents