Bipolar DisorderPhase 3NCT00094926
A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes.
A Phase 3 study testing Risperdal Consta in people with Bipolar Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in the past year. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Risperdal Consta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Feb 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must provide informed consent
- Must agree to receive regular injections
- Must have current diagnosis of bipolar disorder I or II
- Must have at least four episodes of mood disorder in the last year that required psychiatric intervention
Who cannot join
- Female who is or may be pregnant or breastfeeding, who is not at least 1 year postmenopausal, or is not using reliable and adequate birth control
- Psychiatric diagnosis is due directly to effects of a substance or general medical condition
- Substance dependence
- Received treatment with a long-acting injectable antipsychotic less than 2 injection cycles prior to baseline (so, for example, if the drug is injected every 2 weeks, the patient could not enroll in the study if they had received an injection within the last 4 weeks)
- Received Electroconvulsive Therapy (ECT) within the last month
- Began psychotherapy ("talk therapy") within 2 months
- In the past month was treated with any of these medications: carbamazepine, oxcarbazepine, fluoxetine, paroxetine, or clozapine
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Study of the Effectiveness and Safety of RISPERDAL CONSTA Augmentation in Adult Patients With Frequently-relapsing Bipolar Disorder
The purpose of this study is to examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in the past year.
Read the detailed description
Frequently-relapsing (more than 4 episodes in the last year) bipolar patients are a sub-group of patients who have multiple mood episodes in spite of treatment. Currently available treatments may have little impact on number and frequency of manic and/or depressed mood episodes and as a result, these patients have higher than average rates of illness and death. This study examines the effectiveness and side effects of risperidone long-acting injections (LAI) added to treatment as usual (TAU) in frequently-relapsing bipolar patients. The study has two main phases. The first phase is open-label (patients and doctors know what medication and dose the patient is receiving- both risperidone LAI and TAU) and lasts 16 weeks. During that time, patients are treated with the goal that they reach "remission", a predefined level of improvement (decrease in number and severity of mood episodes.) Patients who meet remission criteria at the end of the first phase are randomized (like flipping a coin) to either continue receiving the same dose of risperidone LAI plus TAU, or placebo injections plus TAU. Patients continue in the second phase for 52 weeks, during which time the effectiveness is measured by time to "relapse" (worsening of mood symptoms severe enough to require hospitalization or a major change in medication.) Additional effectiveness, safety, and side effect measures are evaluated throughout the length of the study.
Long-acting risperidone injection 25 mg will be administered every two weeks through a gluteal injection for at least one month. Thereafter, the dose may be increased to 37.5mg then to 50 mg based on clinical response and tolerability. Supplemental use of oral Risperdal (1 to 2 mg/day) will be permitted during the first 12 weeks of the Open-Label Stabilization Phase. Patients must be taking a stable dose of risperidone LAI for the 4 weeks immediately prior to entering the Double-Blind Phase.
- Conditions
- Bipolar Disorder
- Being tested
- Risperdal Consta, placebo
- Keywords
- Risperidal CONSTA, Bipolar disorder, mood episodes, Safety and efficacy, adjuvant therapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperdal ConstaDrug
25, 37.5 or 50mg IM injections every 2wks for 52wks
placeboDrug
matching placebo IM injections every 2wks for 52wks
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Not described Receives: Drug: Risperdal Consta |
| 002 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be determined by measuring the time (in days) from randomization to event/relapse; relapse will be assessed by clinical status, rating scale changes, and pharmacologic stability in double-blind phase.
Measured: 52 weeks
Secondary outcomes (1)
Safety and tolerability as assessed by adverse event reports (every 2 weeks), scores on movement disorder measures, laboratory parameters, vital signs, ECG measures and physical examination reports (every 2-3 months)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2004 (estimated)
- Study startMay 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094926
- Sponsor's protocol ID
- CR004693
- Other IDs
- RISBIP302
- Status last verified
- Apr 2010
- First submitted
- 28 Oct 2004
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Macfadden W, Alphs L, Haskins JT, Turner N, Turkoz I, Bossie C, Kujawa M, Mahmoud R. A randomized, double-blind, placebo-controlled study of maintenance treatment with adjunctive risperidone long-acting therapy in patients with bipolar I disorder who relapse frequently. Bipolar Disord. 2009 Dec;11(8):827-39. doi: 10.1111/j.1399-5618.2009.00761.x.
PubMed 19922552
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled Study of the Effectiveness and Safety of RISPERDAL CONSTA Augmentation in Adult Patients With Frequently-relapsing Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00094926
- Acronym / sponsor ID
- CR004693
- Conditions
- Bipolar Disorder
- Keywords
- Risperidal CONSTA, Bipolar disorder, mood episodes, Safety and efficacy, adjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Study start
- May 2004
- Study completion
- Feb 2007 (actual)
- First posted
- 29 Oct 2004 (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 examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in the past year.
Detailed description
Frequently-relapsing (more than 4 episodes in the last year) bipolar patients are a sub-group of patients who have multiple mood episodes in spite of treatment. Currently available treatments may have little impact on number and frequency of manic and/or depressed mood episodes and as a result, these patients have higher than average rates of illness and death. This study examines the effectiveness and side effects of risperidone long-acting injections (LAI) added to treatment as usual (TAU) in frequently-relapsing bipolar patients. The study has two main phases. The first phase is open-label (patients and doctors know what medication and dose the patient is receiving- both risperidone LAI and TAU) and lasts 16 weeks. During that time, patients are treated with the goal that they reach "remission", a predefined level of improvement (decrease in number and severity of mood episodes.) Patients who meet remission criteria at the end of the first phase are randomized (like flipping a coin) to either continue receiving the same dose of risperidone LAI plus TAU, or placebo injections plus TAU. Patients continue in the second phase for 52 weeks, during which time the effectiveness is measured by time to "relapse" (worsening of mood symptoms severe enough to require hospitalization or a major change in medication.) Additional effectiveness, safety, and side effect measures are evaluated throughout the length of the study.
Long-acting risperidone injection 25 mg will be administered every two weeks through a gluteal injection for at least one month. Thereafter, the dose may be increased to 37.5mg then to 50 mg based on clinical response and tolerability. Supplemental use of oral Risperdal (1 to 2 mg/day) will be permitted during the first 12 weeks of the Open-Label Stabilization Phase. Patients must be taking a stable dose of risperidone LAI for the 4 weeks immediately prior to entering the Double-Blind Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Risperdal Consta |
| 002 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must provide informed consent
- Must agree to receive regular injections
- Must have current diagnosis of bipolar disorder I or II
- Must have at least four episodes of mood disorder in the last year that required psychiatric intervention
Key exclusion criteria (7 listed)
- Female who is or may be pregnant or breastfeeding, who is not at least 1 year postmenopausal, or is not using reliable and adequate birth control
- Psychiatric diagnosis is due directly to effects of a substance or general medical condition
- Substance dependence
- Received treatment with a long-acting injectable antipsychotic less than 2 injection cycles prior to baseline (so, for example, if the drug is injected every 2 weeks, the patient could not enroll in the study if they had received an injection within the last 4 weeks)
- Received Electroconvulsive Therapy (ECT) within the last month
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 |
|---|---|---|
| Risperdal Consta25, 37.5 or 50mg IM injections every 2wks for 52wks | Drug | 001 |
| placebomatching placebo IM injections every 2wks for 52wks | Drug | 002 |
Primary outcome
Efficacy will be determined by measuring the time (in days) from randomization to event/relapse; relapse will be assessed by clinical status, rating scale changes, and pharmacologic stability in double-blind phase.
Time frame: 52 weeks
1 secondary outcome
Safety and tolerability as assessed by adverse event reports (every 2 weeks), scores on movement disorder measures, laboratory parameters, vital signs, ECG measures and physical examination reports (every 2-3 months)
Time frame: 52 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 19 May 2011.
- Derived from this study: PubMed 19922552Macfadden W, Alphs L, Haskins JT, Turner N, Turkoz I, Bossie C, Kujawa M, Mahmoud R. A randomized, double-blind, placebo-controlled study of maintenance treatment with adjunctive risperidone long-acting therapy in patients with bipolar I disorder who relapse frequently. Bipolar Disord. 2009 Dec;11(8):827-39. doi: 10.1111/j.1399-5618.2009.00761.x.
- Adjunctive Risperdal Consta Study in Frequently Relapsing Bipolar Disorder PatientsLink 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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperdal Consta in people with Bipolar Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 inclusion and 7 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 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Efficacy will be determined by measuring the time (in days) from randomization to event/relapse; relapse will be assessed by clinical status, rating scale changes, and pharmacologic stability in double-blind phase. (time frame: 52 weeks). 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 NCT00094926, 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 May 2011.