Bipolar DisorderPhase 4NCT00294255
Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania
A Phase 4 study testing Risperidone in people with Bipolar Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic
- YMRS score>/= 16
- One or more of following:
- 3 MADRS depression items scoring >/=3
- 3 BISS depression items scoring >/=3
- YMRS irritability and aggressive items sum score>/=4
Show all 10Show fewer
- Taking lithium, valproate or lamotrigine at stable dose for 4 wks or longer, with adequate serum level
- age 18 and over
- Male or female
- Inpatient or outpatient
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania
The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features.
Read the detailed description
- The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine, or any combination of the three, in patients experiencing a manic episode with depressive or irritable symptoms.
- To assess the back ground and baseline features associated with response/non-response to risperidone plus mood stabilizer in patients with mania with depressive or irritable features.
- To assess the symptomatic dimensions of response of risperidone added to mood stabilizers in patients with mania with depressive or irritable features.
- Conditions
- Bipolar Disorder
- Being tested
- Risperidone
- Keywords
- mixed mania, depression, irritability
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called risperdal
risperidone will be administered 1-3mg pills, each night, for up to 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Risperidone | Experimental | patients will receive risperidone for up to 20 weeks Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forty percent reduction in YMRS
Measured: 20 weeks
Secondary outcomes (2)
twenty percent reduction in MADRS
Measured: 20 weeks
Remission rate, defined as final score of plus or minus eight on YMRS and MADRS
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
- Investigators
- Vivek Singh, MD, Study director, UT-SanAntonioCharles Bowden, MD, Principal investigator, UT San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294255
- Sponsor's protocol ID
- RIS-USA-T290
- Status last verified
- Feb 2013
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania
- ClinicalTrials.gov ID
- NCT00294255
- Acronym / sponsor ID
- RIS-USA-T290
- Conditions
- Bipolar Disorder
- Keywords
- mixed mania, depression, irritability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- Mar 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 20 Feb 2006 (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 study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features.
Detailed description
- The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine, or any combination of the three, in patients experiencing a manic episode with depressive or irritable symptoms.
- To assess the back ground and baseline features associated with response/non-response to risperidone plus mood stabilizer in patients with mania with depressive or irritable features.
- To assess the symptomatic dimensions of response of risperidone added to mood stabilizers in patients with mania with depressive or irritable features.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risperidone | Experimental | Drug: Risperidonepatients will receive risperidone for up to 20 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic
- YMRS score>/= 16
- One or more of following:
- Taking lithium, valproate or lamotrigine at stable dose for 4 wks or longer, with adequate serum level
- age 18 and over
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| RisperidoneAlso: risperdalrisperidone will be administered 1-3mg pills, each night, for up to 20 weeks | Drug | Risperidone |
Primary outcome
Forty percent reduction in YMRS
Time frame: 20 weeks
2 secondary outcomes
twenty percent reduction in MADRS
Time frame: 20 weeks
Remission rate, defined as final score of plus or minus eight on YMRS and MADRS
Time frame: 20 weeks
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 14 Jun 2018.
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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.
Vivek Singh, MD study director
UT-SanAntonio
Charles Bowden, MD principal investigator
UT San Antonio
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 Bipolar Disorder, run by The University of Texas Health Science Center at San Antonio 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 10 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 14 Jun 2018. 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?
Forty percent reduction in YMRS (time frame: 20 weeks). 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 14 Jun 2018.