Borderline Personality DisorderPhase 4NCT00204347
Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder
A Phase 4 study testing risperidone in people with Borderline Personality Disorder, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- risperidone
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Oct 2007
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of BPD
Who cannot join
- Any other Axis I diagnosis except dysthymia, PTSD, or generalized anxiety disorder;substance abuse within a month; unstable medical illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35205
About this study
Official title: Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder: The UAB Borderline Rating Scale (BRS)
The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. The secondary objective of this study (Study B)is to validate a self-report measure of clinical symptoms specific to the treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).
Read the detailed description
Study A: An open-label, prospective trial of the efficacy and safety of risperidone in the treatment of BPD.The study is 8 weeks in duration, with a screening visit and follow-up visits at the end of Weeks 1,2,3,4,6, and 8. 20 female patients, 19 years or older will be recruited. A full medical and psychiatric history will be taken and a physical exam will be performed by a sstudy physician. A psychosocial assessment will be conducted during the screen.
Study B: The ofjective is to validate the UAB BRS by administering the BRS and other neuropsychological instruments as repeated measures over a 6 week period to 40 patients with BPD.
- Conditions
- Borderline Personality Disorder
- Being tested
- risperidone
- Keywords
- risperidone
- Medical subject headings
- Borderline Personality Disorder
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.
Clinical Global Impression
Brief Symptom Inventory
Secondary outcomes (2)
Beck Depression Inventory
Quality of Life Enjoyment and Satisfaction Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Responsible party
- Principal investigator, Roberta May, University of Alabama at Birmingham
- Investigators
- Celia T. Huston, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204347
- Sponsor's protocol ID
- RIS-DED-WTJ
- Status last verified
- Jun 2021
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder: The UAB Borderline Rating Scale (BRS)
- ClinicalTrials.gov ID
- NCT00204347
- Acronym / sponsor ID
- RIS-DED-WTJ
- Conditions
- Borderline Personality Disorder
- Keywords
- risperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Study start
- Jul 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 20 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 objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. The secondary objective of this study (Study B)is to validate a self-report measure of clinical symptoms specific to the treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).
Detailed description
Study A: An open-label, prospective trial of the efficacy and safety of risperidone in the treatment of BPD.The study is 8 weeks in duration, with a screening visit and follow-up visits at the end of Weeks 1,2,3,4,6, and 8. 20 female patients, 19 years or older will be recruited. A full medical and psychiatric history will be taken and a physical exam will be performed by a sstudy physician. A psychosocial assessment will be conducted during the screen.
Study B: The ofjective is to validate the UAB BRS by administering the BRS and other neuropsychological instruments as repeated measures over a 6 week period to 40 patients with BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of BPD
Key exclusion criteria (1 listed)
- Any other Axis I diagnosis except dysthymia, PTSD, or generalized anxiety disorder;substance abuse within a month; unstable medical illness.
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
Clinical Global Impression
Brief Symptom Inventory
2 secondary outcomes
Beck Depression Inventory
Quality of Life Enjoyment and Satisfaction Questionnaire
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 10 Jun 2021.
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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.
Celia T. Huston, PhD principal investigator
University of Alabama at Birmingham
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 Borderline Personality Disorder, run by University of Alabama at Birmingham 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 1 inclusion and 1 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 10 Jun 2021. 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 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?
Clinical Global Impression. The study lists 2 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 10 Jun 2021.