Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
(failed recruitment efforts)
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178854
First received: September 12, 2005
Last updated: February 5, 2010
Last verified: February 2010

September 12, 2005
February 5, 2010
May 2004
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00178854 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment
Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Treatment Resistant Depression
Drug: Risperidone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
6
December 2006
Not Provided

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.)
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178854
030101, RIS-BIP-404, VUMC30141-R, RIS-USA-T31
Not Provided
Not Provided
Vanderbilt University
Janssen, LP
Principal Investigator: Ronald M Salomon, MD Vanderbilt University
Vanderbilt University
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP