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

This study has been withdrawn prior to enrollment.
(failed recruitment efforts)
ClinicalTrials.gov Identifier:
First Posted: September 15, 2005
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Janssen, LP
Information provided by (Responsible Party):
Vanderbilt University Medical Center
September 12, 2005
September 15, 2005
April 4, 2017
May 2004
March 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00178854 on ClinicalTrials.gov Archive Site
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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.
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Treatment Resistant Depression
Drug: Risperidone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2006
March 2006   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Vanderbilt University Medical Center
Vanderbilt University Medical Center
Janssen, LP
Principal Investigator: Ronald M Salomon, MD Vanderbilt University Medical Center
Vanderbilt University Medical Center
March 2017

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