Unipolar DepressionPhase 3NCT00179244
Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
A Phase 3 study testing Rispridone (drug) and Bupropion ER (drug) in people with Unipolar Depression, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the comparative effectiveness of Risperdal (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test the relative safety of the combinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Rispridone (drug) and Bupropion ER (drug)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Apr 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years or older
- DSM-IV diagnosis of major depressive disorder of at least moderate severity, but without psychotic features
- Ham-D 17 score of 18 or above
- Have a documentable history of 2 prior adequate trials of antidepressants including an SSRI without sufficient response. A clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms.
- Must be currently on an serotonin uptake inhibitor (to include venlafaxine or duloxetine) at an adequate dose for at least 3 weeks.
- Ability and willingness to provide consent for participation in the study.
Who cannot join
- Any medical condition that would preclude treatment with an SSRI, risperidone, or bupropion ER
- Any clinically significant unstable medical condition
- Diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder
- Current psychotic symptoms (hallucination or delusions)
- Alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month
- Documented non-response to the combination of a novel antipsychotic or bupropion ER and a SSRI
Show all 9Show fewer
- Concomitant use of any psychotropic other than an SSRI or zolpidem (PRN for sleep)
- Score of 4 on the suicide item of the Ham-D scale and determination by the investigator of significant suicide risk
- Known sensitivity to risperidone or bupropion ER
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37211
About this study
The purpose of this study is to evaluate the comparative effectiveness of Risperdal (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test the relative safety of the combinations.
Read the detailed description
Major depression is a severe disorder with serious consequences. Effective treatments are available; however, in clinical trials 30-40% of patients do not experience even a 50% reduction in depression severity scores, while 50-70% fail to achieve a full therapeutic response. Futhermore, impairment from the disorder continues essentially unabated in patients who are treated but do not fully remit. If anything, the situation is at least as bad or not worse in clinical practice. Clearly, alternatives are needed to manage this common clinical condition.
The addition of bupropion ER (extended release) to an SSRI has empirical support, and has become the most common augmentation strategy in the US. A comparative trial of the combination of risperidone or bupropion ER added to an SSRI in treatment resistant deperssion could help support risperidone for this condition; such a trial seems warranted at this time.
Patients who are currently on a SSRI at an adequate dosage for at least 3 weeks with no response, will be randomly assigned (open-label) to either risperidone or bupropion ER augmentation for a period of 6 weeks. Patients will be followed weekly at the beginning and bi-weekly towards the end of the trial to compare the response of each group.
- Conditions
- Unipolar Depression
- Being tested
- Rispridone (drug) and Bupropion ER (drug)
- Keywords
- Treatment Resistant Depression
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rispridone (drug) and Bupropion ER (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS (Montgomery Asberg's Depression Rating Scale)
Secondary outcomes (4)
HAM-D(Hamilton Rating Scale for Depression ) 17-item
BDI (Beck Depression Inventory)
HAM-A (Hamilton Rating Scale for Anxiety)
Clinical Global Impression Scale and Severity and Improvement.
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 startJul 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- 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 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Responsible party
- Principal investigator, Richard C. Shelton, Vanderbilt University
- Investigators
- Richard C Shelton, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179244
- Sponsor's protocol ID
- RIS vs. BUP Augmentation Depr.
- Other IDs
- 040309
- Status last verified
- Jun 2015
- First submitted
- 13 Sep 2005
- Last updated
- 2 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT00179244
- Acronym / sponsor ID
- RIS vs. BUP Augmentation Depr.
- Conditions
- Unipolar Depression
- Keywords
- Treatment Resistant Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Study start
- Jul 2004
- Study completion
- Apr 2005 (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.
The purpose of this study is to evaluate the comparative effectiveness of Risperdal (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test the relative safety of the combinations.
Detailed description
Major depression is a severe disorder with serious consequences. Effective treatments are available; however, in clinical trials 30-40% of patients do not experience even a 50% reduction in depression severity scores, while 50-70% fail to achieve a full therapeutic response. Futhermore, impairment from the disorder continues essentially unabated in patients who are treated but do not fully remit. If anything, the situation is at least as bad or not worse in clinical practice. Clearly, alternatives are needed to manage this common clinical condition.
The addition of bupropion ER (extended release) to an SSRI has empirical support, and has become the most common augmentation strategy in the US. A comparative trial of the combination of risperidone or bupropion ER added to an SSRI in treatment resistant deperssion could help support risperidone for this condition; such a trial seems warranted at this time.
Patients who are currently on a SSRI at an adequate dosage for at least 3 weeks with no response, will be randomly assigned (open-label) to either risperidone or bupropion ER augmentation for a period of 6 weeks. Patients will be followed weekly at the beginning and bi-weekly towards the end of the trial to compare the response of each group.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 18 years or older
- DSM-IV diagnosis of major depressive disorder of at least moderate severity, but without psychotic features
- Ham-D 17 score of 18 or above
- Have a documentable history of 2 prior adequate trials of antidepressants including an SSRI without sufficient response. A clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms.
- Must be currently on an serotonin uptake inhibitor (to include venlafaxine or duloxetine) at an adequate dose for at least 3 weeks.
Key exclusion criteria (9 listed)
- Any medical condition that would preclude treatment with an SSRI, risperidone, or bupropion ER
- Any clinically significant unstable medical condition
- Diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder
- Current psychotic symptoms (hallucination or delusions)
- Alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month
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 |
|---|---|---|
| Rispridone (drug) and Bupropion ER (drug) | Drug | – |
Primary outcome
MADRS (Montgomery Asberg's Depression Rating Scale)
4 secondary outcomes
HAM-D(Hamilton Rating Scale for Depression ) 17-item
BDI (Beck Depression Inventory)
HAM-A (Hamilton Rating Scale for Anxiety)
Clinical Global Impression Scale and Severity and Improvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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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.
Richard C Shelton, 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 3 study testing Rispridone (drug) and Bupropion ER (drug) in people with Unipolar Depression, run by Vanderbilt University 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 2 Jun 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
MADRS (Montgomery Asberg's Depression Rating Scale). It is what the study was designed to measure, not a finding.
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 2 Jun 2015.