Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment

NCT ID: NCT00178854

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2006-03-31

Brief Summary

This is a study of the chemistry of depression in people who are taking an antidepressant but it is not working well. The changes in brain chemicals that occur when an SSRI type antidepressant is supplemented with risperidone (Risperdal®) will be studied. Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Risperidone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Treatment-resistant unipolar depression (previous diagnosis of MDD by SCID-P or DSM-IV) as defined by inadequate or waning response to adequate SRI treatment for at least 4 weeks
• HRSD (17-item) score greater than or equal to 15 while taking an SRI with no past suicide attempts for one year and no current ideation, intent, or plan. Repeat HRSD scores should remain greater than or equal to 15 for two consecutive weeks after initial screening.

Exclusion Criteria

• Adverse extrapyramidal or other response to dopamine antagonist effects in the past.
• Any adverse response to risperidone in the past.
• Residence beyond 30 miles from Vanderbilt University.
• Inability to comply with study requirements.
• Psychotic hallucinations
• Past diagnosis of Bipolar, Dissociative, or Psychotic Disorders.
• Substance or alcohol abuse, other psychotropic, or any investigational or herbal preparation within 3 months or Substance dependency within 6 months prior to initial screening (by SCID-P).
• History of impulsive suicidal gestures or attempts within 2 years (must have no suicidal ideation, intent or plan for a period of one year).
• Primary diagnosis of Cluster B or C personality disorder, or significant comorbidity due to Borderline, Antisocial, Schizoid, or Schizotypal Personality Disorder (by SCID-II).
• Seasonal affective syndromes, including Seasonal Affective Disorder (because the duration of the study is long enough to expect "spontaneous" [natural] remissions.)
• Chronic (daily) benzodiazepine use in the past month or any use 1 week prior to sampling.
• Regular analgesic use. No antipyretic medication is allowed in the pre- through post-sampling period, leaving difficulty with pain management for pain-prone patients.
• Medication use deemed by the investigator unacceptable for study protocol.
• Pregnancy or inability to cooperate with effective contraceptive method (double barrier).
• Physical condition or significant medical history of any illness that presents risk with lumbar catheterization.
• Lactation.
• Blood donation within 90 days prior to or planned 90 days following the study.
• Severe migraine history.
• Daily tobacco use (absolute abstinence is required during the entire study.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald M Salomon, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

RIS-BIP-404

Identifier Type: -

Identifier Source: secondary_id

VUMC30141-R

Identifier Type: -

Identifier Source: secondary_id

RIS-USA-T31

Identifier Type: -

Identifier Source: secondary_id

030101

Identifier Type: -

Identifier Source: org_study_id