Expired Study
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Nashville, Tennessee 37212


Purpose:

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.


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.)


Study is Available At:


Original ID:

030101


NCT ID:

NCT00178854


Secondary ID:

RIS-BIP-404


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

failed recruitment efforts


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

6


Enrollment Type:


Overall Contact Information

Official Name:Ronald M Salomon, MD
Principal Investigator
Vanderbilt University

Study Dates

Start Date:May 2004
Completion Date:December 2006
Verification Date:February 2010
Last Changed Date:February 5, 2010
First Received Date:September 12, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Risperidone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Janssen, LP

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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