Treatment Resistant DepressionPhase 4NCT00178854
Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment
A Phase 4 study testing Risperidone in people with Treatment Resistant Depression, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Risperidone
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Mar 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
- Conditions
- Treatment Resistant Depression
- Being tested
- Risperidone
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionMar 2006
- Study completionMar 2006
Why it stopped: failed recruitment efforts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
- Investigators
- Ronald M Salomon, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178854
- Sponsor's protocol ID
- 030101
- Other IDs
- RIS-BIP-404, VUMC30141-R, RIS-USA-T31
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 4 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment
- ClinicalTrials.gov ID
- NCT00178854
- Acronym / sponsor ID
- 030101
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: failed recruitment efforts
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- May 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M Salomon, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone in people with Treatment Resistant Depression, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.