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This study has been withdrawn prior to enrollment.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
  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.


Condition Intervention Phase
Treatment Resistant Depression
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Estimated Enrollment: 6
Study Start Date: May 2004
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178854

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Janssen, LP
Investigators
Principal Investigator: Ronald M Salomon, MD Vanderbilt University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00178854     History of Changes
Other Study ID Numbers: 030101, RIS-BIP-404, VUMC30141-R, RIS-USA-T31
Study First Received: September 12, 2005
Last Updated: February 5, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 16, 2014