Bipolar I DisorderPhase 3NCT00177164
Risperdal Consta for Bipolar Disorder
A Phase 3 study testing Injectable Risperidone (Consta) or oral antipsychotic in people with Bipolar I Disorder, run by University of Pittsburgh at 4 sites in United States.
Trial summary
We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- Injectable Risperidone (Consta) or oral antipsychotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2003to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV - TR diagnoses of bipolar disorder (I or II or NOS).
- Age 18 to 70 years
- Men or women
- Any Ethnicity
- Currently receiving or willing to receive treatment at sites associated with the Western Psychiatric Institute and Clinic -University of Pittsburgh Medical Center (inpatient or ambulatory) or Mon Yough Community Services, Inc. or at Mayview State Hospital, Bridgeville, PA (inpatient)
- Able to provide competent and sign an informed consent document
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- It is clinically appropriate in the eligible individual to consider antipsychotic treatment for at least 15 months (clinician and investigator determined)
- It is clinically appropriate to switch antipsychotic treatment to one of the second generation antipsychotic agents being evaluated in this study.
- There is no known contraindication for the use of either risperidone or for more than two of the antipsychotic agents being considered in the study (Investigator determined)
- At entry (at the screening visit, and just prior to randomization) Y-MRS (Young-Mania rating scale, Young et al., 1978) total score > 15 in bipolar disorder patients entering in a manic or mixed or hypomanic or NOS episode.
- Either life-time or current comorbid substance abuse or dependence is permitted (unless the Investigator and referring physician opines the substance abuse is likely to significantly interfere with either the diagnosis of the Axis I condition or to compromise patients safety due to withdrawal issues (Investigator determined).
- Screening physical and laboratory/EKG procedures are within acceptable limits
Who cannot join
- Actively suicidal or dangerous to others (Investigator opines that it is inappropriate to involve the potential subject in the study)
- Pregnant or lactating women
- Women in the reproductive age group who are not using any acceptable contraception (abstinence is not acceptable) or intend to become pregnant during the trial
- Subjects who are likely to face incarceration during the study duration (and for those already in the study, the continued participation of such subjects will be evaluated on a case-by-case basis)
- Patients currently receiving clozapine (or within six weeks prior to randomization) are ineligible for the study
- Subjects currently receiving a depot neuroleptic injectable agent, or within 2 injection cycles of receiving the injection prior to randomization.
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- Allergy or serious side effects (for instance - neuroleptic malignant syndrome) to either risperidone or to more than two of the other second-generation antipsychotic agents that have been approved for use in the U.S.A. (olanzapine, quetiapine, ziprasidone, aripiprazole-per investigator and referring clinician).
- Treatment resistance to either risperidone, or to more than two of the other antipsychotic agents in this trial (olanzapine, quetiapine, ziprasidone, aripiprazole).
- This is the first episode of mania, mixed or hypomania for patients.
- Current (or within one month prior to randomization) participation in an investigational drug/device study.
- Currently participating in another study that would confound the present study objectives (per investigator)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mayview State Hospital
Bridgeville, Pennsylvania, 15017-1599
Dubois Regional Medical Center
DuBois, Pennsylvania, 15801
Mon-Yough Community Services, Inc.
McKeesport, Pennsylvania, 15132
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213-2593
About this study
Official title: A Random Assignment,Parallel Group, Open Label Comparison of Clinical Outcomes and Resource Utilization Among Bipolar Disorder Patients Receiving Either Long Acting Injectable Risperidone Microspheres (Risperdal Consta® ) or Other Second Generation Oral Antipsychotic Agents: A 15 Month Study
We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated and cross-tapered during a 3 month titration and stabilization phase. They were followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.
Read the detailed description
OBJECTIVE:
To evaluate if a long acting injectable form of risperidone offers clinical advantages over comparison oral second generation antipsychotic agents following titration and stabilization in bipolar subjects. In keeping with current practice, it is expected the vast majority of patients will also be receiving either lithium or valproate or other anticonvulsants. Following the stabilization phase several clinical events will be evaluated for up to 15 months in the two treatment groups to examine differences in clinical outcomes between those receiving the injectable versus oral medicines.
RESEARCH PLAN:
We intend to recruit 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who are about to initiate or to switch their antipsychotic agent. Patients will be titrated and cross-tapered during a 3 month titration and stabilization phase. Those who transition successfully and show some improvement will be followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. will be evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.
METHODS:
An open design, but treatment to either the long acting risperidone or to the oral second generation antipsychotic agents is randomly assigned. A board independent of the day-to-day clinical events will code the primary clinical outcomes of interest without knowledge of treatment assignment. The board will be provided clinical summaries of these events without revealing the treatment assignment.
SIGNIFICANCE:
The use of a long acting injectable second generation antipsychotic agent may offer advantages of treatment continuity and adherence in bipolar patients permitting improved clinical stability and improved psychosocial and functional outcomes. Such stability is difficult to achieve in the face of frequent treatment discontinuations seen with oral agents. The improved tolerability of the second generation antipsychotic agents may change the perception of long acting injections. For instance, these agents are likely to be more acceptable to patients, families and clinicians and therefore likely be used much sooner in the treatment algorithms of bipolar patients than in the past. This study will provide a treatment effect size to statistically power future comparisons of long-acting injectable vs. oral antipsychotic agents in persons with bipolar disorder
- Conditions
- Bipolar I Disorder
- Being tested
- Injectable Risperidone (Consta) or oral antipsychotic
- Keywords
- Bipolar I Disorder, Risperidone Consta - Long Acting Injection, Oral second generation antipsychotic agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Risperidone (Consta) or oral antipsychoticDrug
Also called Long actiing risperidone injection (Consta), oral risperidone (risperdal)., Olanzapine (Zyprexa), Quetiapine (Seroquel), Ziprasidone (Geodon), Aripiprazole (Ablify)
Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oral Risperidone followed by Long acting Risperidone injections (Consta) Receives: Drug: Injectable Risperidone (Consta) or oral antipsychotic |
| 2 | Active comparator | Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) Receives: Drug: Injectable Risperidone (Consta) or oral antipsychotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.
Measured: Upto 15 months
Secondary outcomes (3)
BMI
BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups
Measured: baseline to end of 15 months
Number of Participants With Treatment - Emergent Hyperglycemia
Number of participants with hyperglycemia based on safety labs
Measured: from baseline to end of 15 months
Number of Participants With Treatment Emergent Hyperlipidemia
Number of participants with Hyperlipidemia as determined by safety labs
Measured: from baseline to end of 15 months
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 startNov 2003
- Primary completionMar 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Principal investigator, K.N. Roy Chengappa, University of Pittsburgh
- Investigators
- K.N. Roy Chengappa, MD, Principal investigator, Western Psychiatric Institute and Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177164
- Sponsor's protocol ID
- RIS-PSY-405
- Other IDs
- Univ. Pittsburgh IRB #0403091
- Status last verified
- Mar 2016
- First submitted
- 12 Sep 2005
- Last updated
- 19 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chengappa KN, Turkin SR, Schlicht PJ, Murphy SL, Brar JS, Fagiolini A, Houck PR, Garbutt RG, Fredrick N. A Pilot, 15-month, randomised effectiveness trial of Risperidone long-acting injection (RLAI) versus oral atypical antipsychotic agents (AAP) in persons with bipolar disorder. Acta Neuropsychiatr. 2010 Apr;22(2):68-80. doi: 10.1111/j.1601-5215.2010.00458.x.
PubMed 25385032
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random Assignment,Parallel Group, Open Label Comparison of Clinical Outcomes and Resource Utilization Among Bipolar Disorder Patients Receiving Either Long Acting Injectable Risperidone Microspheres (Risperdal Consta® ) or Other Second Generation Oral Antipsychotic Agents: A 15 Month Study
- ClinicalTrials.gov ID
- NCT00177164
- Acronym / sponsor ID
- RIS-PSY-405
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder, Risperidone Consta - Long Acting Injection, Oral second generation antipsychotic agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- Nov 2003
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 8 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated and cross-tapered during a 3 month titration and stabilization phase. They were followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.
Detailed description
OBJECTIVE:
To evaluate if a long acting injectable form of risperidone offers clinical advantages over comparison oral second generation antipsychotic agents following titration and stabilization in bipolar subjects. In keeping with current practice, it is expected the vast majority of patients will also be receiving either lithium or valproate or other anticonvulsants. Following the stabilization phase several clinical events will be evaluated for up to 15 months in the two treatment groups to examine differences in clinical outcomes between those receiving the injectable versus oral medicines.
RESEARCH PLAN:
We intend to recruit 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who are about to initiate or to switch their antipsychotic agent. Patients will be titrated and cross-tapered during a 3 month titration and stabilization phase. Those who transition successfully and show some improvement will be followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. will be evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.
METHODS:
An open design, but treatment to either the long acting risperidone or to the oral second generation antipsychotic agents is randomly assigned. A board independent of the day-to-day clinical events will code the primary clinical outcomes of interest without knowledge of treatment assignment. The board will be provided clinical summaries of these events without revealing the treatment assignment.
SIGNIFICANCE:
The use of a long acting injectable second generation antipsychotic agent may offer advantages of treatment continuity and adherence in bipolar patients permitting improved clinical stability and improved psychosocial and functional outcomes. Such stability is difficult to achieve in the face of frequent treatment discontinuations seen with oral agents. The improved tolerability of the second generation antipsychotic agents may change the perception of long acting injections. For instance, these agents are likely to be more acceptable to patients, families and clinicians and therefore likely be used much sooner in the treatment algorithms of bipolar patients than in the past. This study will provide a treatment effect size to statistically power future comparisons of long-acting injectable vs. oral antipsychotic agents in persons with bipolar disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Injectable Risperidone (Consta) or oral antipsychoticOral Risperidone followed by Long acting Risperidone injections (Consta) |
| 2 | Active comparator | Drug: Injectable Risperidone (Consta) or oral antipsychoticOral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- DSM-IV - TR diagnoses of bipolar disorder (I or II or NOS).
- Age 18 to 70 years
- Men or women
- Any Ethnicity
- Currently receiving or willing to receive treatment at sites associated with the Western Psychiatric Institute and Clinic -University of Pittsburgh Medical Center (inpatient or ambulatory) or Mon Yough Community Services, Inc. or at Mayview State Hospital, Bridgeville, PA (inpatient)
Key exclusion criteria (11 listed)
- Actively suicidal or dangerous to others (Investigator opines that it is inappropriate to involve the potential subject in the study)
- Pregnant or lactating women
- Women in the reproductive age group who are not using any acceptable contraception (abstinence is not acceptable) or intend to become pregnant during the trial
- Subjects who are likely to face incarceration during the study duration (and for those already in the study, the continued participation of such subjects will be evaluated on a case-by-case basis)
- Patients currently receiving clozapine (or within six weeks prior to randomization) are ineligible for the study
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 |
|---|---|---|
| Injectable Risperidone (Consta) or oral antipsychoticAlso: Long actiing risperidone injection (Consta), oral risperidone (risperdal)., Olanzapine (Zyprexa), Quetiapine (Seroquel), Ziprasidone (Geodon), Aripiprazole (Ablify)Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder | Drug | 1, 2 |
Primary outcome
Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.
Time frame: Upto 15 months
3 secondary outcomes
BMI
Time frame: baseline to end of 15 months
Number of Participants With Treatment - Emergent Hyperglycemia
Time frame: from baseline to end of 15 months
Number of Participants With Treatment Emergent Hyperlipidemia
Time frame: from baseline to end of 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25385032Chengappa KN, Turkin SR, Schlicht PJ, Murphy SL, Brar JS, Fagiolini A, Houck PR, Garbutt RG, Fredrick N. A Pilot, 15-month, randomised effectiveness trial of Risperidone long-acting injection (RLAI) versus oral atypical antipsychotic agents (AAP) in persons with bipolar disorder. Acta Neuropsychiatr. 2010 Apr;22(2):68-80. doi: 10.1111/j.1601-5215.2010.00458.x.
- Link to article findings in Acta NeuropsychiatricaLink provided by the sponsor.
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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.
K.N. Roy Chengappa, MD principal investigator
Western Psychiatric Institute and Clinic
4 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 Injectable Risperidone (Consta) or oral antipsychotic in people with Bipolar I Disorder, run by University of Pittsburgh at 4 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 12 inclusion and 11 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 8 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents. (time frame: Upto 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00177164, which also lists 1 linked publication.
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 19 Apr 2016.