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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen, LP
• Treatments: Risperidone

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.