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

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. Identifier: NCT00178854
Recruitment Status : Withdrawn (failed recruitment efforts)
First Posted : September 15, 2005
Last Update Posted : April 4, 2017
Janssen, LP
Information provided by (Responsible Party):
Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: Risperidone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment
Study Start Date : May 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178854

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

Additional Information:
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Responsible Party: Vanderbilt University Medical Center Identifier: NCT00178854     History of Changes
Other Study ID Numbers: 030101
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Depressive Disorder, Treatment-Resistant
Depressive Disorder
Mood Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents