Major DepressionPhase 3NCT00174577
Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant
A Phase 3 study testing Risperidone in people with Major Depression, run by Rhode Island Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of risperidone augmentation in patients who have failed to respond or only partially responded to an adequate trial of an antidepressant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Risperidone
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2003to Feb 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with major depression or partially remitted depression
- currently receiving an adequate trial of an antidepressant
Who cannot join
- diagnosis of bipolar I or bipolar II disorder
- psychotic features
- substance dependence or abuse in the past three months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University School of Medicine
Atlanta, Georgia, 30329
Mood Disorders Program - Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant
The purpose of this study is to assess the safety and efficacy of risperidone augmentation in patients who have failed to respond or only partially responded to an adequate trial of an antidepressant.
Read the detailed description
Specific Aims: The goal of this study was to assess the safety and efficacy of risperidone augmentation in patients with major depression who failed to respond, or only partially responded, to an adequate trial of an antidepressant medication. Patients who met this criteria received adjunctive risperidone (1- 3 mg.) for an additional four-week treatment trial.
Subject Population: A total sample of 84 patients completed the study at two sites (Rhode Island Hospital/Brown University, n=42, Emory University, n=42).
Methods/Design: Patients who met criteria for unipolar depression and failed to respond, or partially responded, to an adequate trial of antidepressant medication were randomized to risperidone or a placebo for an additional 4 week treatment trial while continuing on the same dose of their antidepressant medication. Randomization was at a 2:1 ratio of risperidone to placebo.
Data Analysis: Patient outcome (recovery status) of the two treatment conditions were compared using a MADRS rating < 10 to denote remission while improvement was defined as a 50% decrease from baseline to end of study. Odds ratio were examined to see if risperidone augmentation significantly affected the chance of recovery from depression at the end of 4 weeks of treatment.
- Conditions
- Major Depression
- Being tested
- Risperidone
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms,change score on MADRS scale at 4 weeks
Group differences on HRS-D scores
Group differences on remission and improvement
Secondary outcomes (2)
Between group differences on quality-of-life measures
Group differences of anxiety and psychosocial factors
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 startFeb 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium, Emory University
- Investigators
- Gabor I Keitner, M.D., Principal investigator, Rhode Island Hospital/Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174577
- Sponsor's protocol ID
- RIS-Dep-402
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant
- ClinicalTrials.gov ID
- NCT00174577
- Acronym / sponsor ID
- RIS-Dep-402
- Conditions
- Major Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium, Emory University
- Study start
- Feb 2003
- Study completion
- Feb 2005
- 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 assess the safety and efficacy of risperidone augmentation in patients who have failed to respond or only partially responded to an adequate trial of an antidepressant.
Detailed description
Specific Aims: The goal of this study was to assess the safety and efficacy of risperidone augmentation in patients with major depression who failed to respond, or only partially responded, to an adequate trial of an antidepressant medication. Patients who met this criteria received adjunctive risperidone (1- 3 mg.) for an additional four-week treatment trial.
Subject Population: A total sample of 84 patients completed the study at two sites (Rhode Island Hospital/Brown University, n=42, Emory University, n=42).
Methods/Design: Patients who met criteria for unipolar depression and failed to respond, or partially responded, to an adequate trial of antidepressant medication were randomized to risperidone or a placebo for an additional 4 week treatment trial while continuing on the same dose of their antidepressant medication. Randomization was at a 2:1 ratio of risperidone to placebo.
Data Analysis: Patient outcome (recovery status) of the two treatment conditions were compared using a MADRS rating < 10 to denote remission while improvement was defined as a 50% decrease from baseline to end of study. Odds ratio were examined to see if risperidone augmentation significantly affected the chance of recovery from depression at the end of 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with major depression or partially remitted depression
- currently receiving an adequate trial of an antidepressant
Key exclusion criteria (3 listed)
- diagnosis of bipolar I or bipolar II disorder
- psychotic features
- substance dependence or abuse in the past three months
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
Depression symptoms,change score on MADRS scale at 4 weeks
Group differences on HRS-D scores
Group differences on remission and improvement
2 secondary outcomes
Between group differences on quality-of-life measures
Group differences of anxiety and psychosocial factors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Gabor I Keitner, M.D. principal investigator
Rhode Island Hospital/Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone in people with Major Depression, run by Rhode Island Hospital at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Depression symptoms,change score on MADRS scale at 4 weeks. The study lists 3 primary outcomes in all. 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 15 Sep 2005.