Bipolar DisorderPhase 4NCT00167479
A Study of Risperidone Monotherapy in Bipolar Anxiety
A Phase 4 study testing risperidone (Risperdal) in people with Bipolar Disorder and Panic Disorder, run by University of South Florida at 3 sites in United States.
Trial summary
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Panic Disorder, Generalized Anxiety Disorder
- What is being tested?
- risperidone (Risperdal)
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2003to Sep 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
- Subjects must be 18 years of age or older.
- Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV criteria.
- Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) .
- Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4.
- Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4.
- Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline.
- Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, double barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.
Who cannot join
- Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria.
- Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria.
- Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
- Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5).
- Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3).
- Subjects with clinically significant suicidal or homicidal ideation.
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- Subjects with current psychotic symptoms.
- Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
- Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.
- Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests.
- Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone.
- Women who are pregnant or nursing.
- Subjects who have received an experimental drug or used an experimental device within 30 days.
- Subjects who have a history of neuroleptic malignant syndrome.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinatti
Cincinnati, Ohio
University of Texas Southwestern Medical Center
Dallas, Texas
University of South Florida Psychiatry Center
Tampa, Florida, 33613-4788
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Current at Least Moderately Severe Anxiety and Lifetime Panic Disorder or Generalized Anxiety Disorder
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
Read the detailed description
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of risperidone monotherapy in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current at least moderately severe anxiety symptoms. Approximately 90 subjects will be enrolled to obtain 60 subjects who complete the 8-week trial. Subjects will be randomized to risperidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, and prn zolpidem and zaleplon throughout the study for the management of insomnia. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.
- Being tested
- risperidone (Risperdal)
- Keywords
- Bipolar Anxiety, Bipolar Disorder, Anxiety, Panic Disorder, Generalized Anxiety Disorder, GAD, Risperidone, Double-Blind, Placebo Controlled
- Medical subject headings
- Bipolar Disorder, Panic Disorder, Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidone (Risperdal)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Global Improvement Scale (CGI-21)
Secondary outcomes (8)
Sheehan Panic Disorder Scale (SPS)
The Psychic and Somatic factors of the HAM-A
Young Mania Rating Scale, Total Score
Inventory of Depressive Symptoms, Total Score
Patient Global Improvement Scale (PGI-21)
The Clinician Global Improvement-Bipolar (CGI-BP)
The Family Impact Scale (FIS)
The Sheehan Disability Scale - Total Disability Score, Work Disability Score, Social Disability Score, Family Disability Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2003
- Study completionSep 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 University of South FloridaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Investigators
- David V. Sheehan, MD, MBA, Principal investigator, University of South Florida College of MedicineSusan L. McElroy, MD, Principal investigator, University of Cincinatti, Department of PsychiatryTrisha - Suppes, MD, PhD, Principal investigator, University of Texas Southwestern Medical CenterPaul E. Keck, MD, Principal investigator, University of Cincinatti, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167479
- Sponsor's protocol ID
- 101541d
- Other IDs
- RIS-BIP-408
- Status last verified
- Sep 2006
- First submitted
- 10 Sep 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Current at Least Moderately Severe Anxiety and Lifetime Panic Disorder or Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00167479
- Acronym / sponsor ID
- 101541d
- Keywords
- Bipolar Anxiety, Bipolar Disorder, Anxiety, Panic Disorder, Generalized Anxiety Disorder, GAD, Risperidone, Double-Blind
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- Sep 2003
- Study completion
- Sep 2006
- First posted
- 14 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 specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
Detailed description
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of risperidone monotherapy in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current at least moderately severe anxiety symptoms. Approximately 90 subjects will be enrolled to obtain 60 subjects who complete the 8-week trial. Subjects will be randomized to risperidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, and prn zolpidem and zaleplon throughout the study for the management of insomnia. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be 18 years of age or older.
- Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV criteria.
- Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) .
- Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4.
- Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4.
Key exclusion criteria (14 listed)
- Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria.
- Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria.
- Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
- Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5).
- Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3).
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 (Risperdal) | Drug | – |
Primary outcome
Clinician Global Improvement Scale (CGI-21)
8 secondary outcomes
Sheehan Panic Disorder Scale (SPS)
The Psychic and Somatic factors of the HAM-A
Young Mania Rating Scale, Total Score
Inventory of Depressive Symptoms, Total Score
Patient Global Improvement Scale (PGI-21)
The Clinician Global Improvement-Bipolar (CGI-BP)
The Family Impact Scale (FIS)
The Sheehan Disability Scale - Total Disability Score, Work Disability Score, Social Disability Score, Family Disability Score
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 11 Sep 2006.
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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.
David V. Sheehan, MD, MBA principal investigator
University of South Florida College of Medicine
Susan L. McElroy, MD principal investigator
University of Cincinatti, Department of Psychiatry
Trisha - Suppes, MD, PhD principal investigator
University of Texas Southwestern Medical Center
3 sites 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 (Risperdal) in people with Bipolar Disorder and Panic Disorder, run by University of South Florida at 3 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 8 inclusion and 14 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 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Clinician Global Improvement Scale (CGI-21). 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 11 Sep 2006.