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

NCT ID: NCT00044681

Last Updated: 2011-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2004-03-31

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.

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.

Conditions

Depressive Disorder; Depressive Disorder, Major; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

risperidone

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=451&filename=CR002143_CSR.pdf

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

Other Identifiers

CR002143

Identifier Type: -

Identifier Source: org_study_id