This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes (NCT00132678), a randomized phase 3 study. The primary outcome is Number of Participants Who Had a Mood Relapse..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00132678 |
| Phase | Phase 3 |
| Condition | Bipolar Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 559 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Results posted | Yes |
2. Clinical Question
Population
People with bipolar 1 disorder were the intended study population. The registry record describes an intention-to-treat population, while also stating that 28 subjects from a Good Clinical Practice noncompliant site and a site with alleged research misconduct were excluded from efficacy analyses. The record does not give further eligibility criteria or a complete account of how this affected the analysis population.
Intervention
Risperdal Consta was given by intramuscular injection every 2 weeks. The listed doses were 12.5, 25, 37.5 or 50mg. The record does not explain how dose selection or dose changes were determined.
Comparator
The comparator was matching placebo, also given by intramuscular injection every 2 weeks. The study was randomized, parallel-group, and described as quadruple-masked. Details about who was masked and how randomization was implemented are not reported in the registry record.
Primary question
The primary endpoint was the number of participants who had a mood relapse over a timeframe of 24 months. Relapse included specified mood episodes, treatment intervention, hospitalization, clinical scale thresholds, or a treatment change judged necessary by the investigator. The registry record does not report the arm-level primary endpoint results or a treatment-effect estimate, so the size and precision of a randomized comparison cannot be assessed from the posted results.
3. Trial Design
This was a phase 3, randomized, parallel-group study comparing long-acting intramuscular risperidone with matching placebo in people with bipolar 1 disorder. The official title describes a double-blind, placebo-controlled study with an open-label extension; the registry fields characterize masking as quadruple. The record does not explain these different masking descriptions or specify which people remained masked during each study period. The trial status is completed.
Enrollment is listed as 559. That figure describes the overall study enrollment and should not be treated as the number analyzed for the primary endpoint or as the number in either randomized arm. Arm-specific randomized, treated, and analyzed counts are not reported in the registry record. The efficacy population description says intention to treat, but also notes exclusions from efficacy analyses related to a Good Clinical Practice noncompliant site and a site with alleged research misconduct. The precise analysis denominator and handling of those exclusions are not clear from the record.
The randomized comparison used Risperdal Consta at listed doses of 12.5, 25, 37.5 or 50mg, administered every 2 weeks, versus matching placebo on the same schedule. The record does not state the allocation ratio, describe allocation concealment, or explain how the dose levels were assigned. It also does not provide details of adherence, concomitant treatment, or whether any protocol changes occurred.
The registry lists a 24-month timeframe for the primary endpoint. The official title also mentions an open-label extension, and the safety entries include open-label groups. Those extension groups should not be read as additional randomized placebo-controlled comparisons: the record does not provide enough detail to establish their relationship to the randomized groups, their entry criteria, or their follow-up. Start and primary completion are recorded as 2005-02 and 2007-10, respectively. Further operational details, including the protocol’s sample-size justification and the conduct of interim analyses, are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Subjects with an acute episode or who were stable on another antipsychotic entered Period II; Period II responders entered Period III. Subjects stable on RIS at screening entered Period III directly. Subjects who maintained response and had a stable dose of RIS LAI for the last 8 weeks of Period III were randomized to RIS LAI or placebo(Period IV).
Period II (Open-Label Oral Risperidone)
| Stage | RISPERDAL CONSTA | Placebo | Open-Label Oral Risperidone |
|---|---|---|---|
| STARTED | 0 | 0 | 440 |
| COMPLETED | 0 | 0 | 382 |
| NOT COMPLETED | 0 | 0 | 58 |
Reasons for not completing this period:
| Reason | RISPERDAL CONSTA | Placebo | Open-Label Oral Risperidone |
|---|---|---|---|
| Death | 0 | 0 | 1 |
| Adverse Event | 0 | 0 | 13 |
| Non responder | 0 | 0 | 6 |
| Ineligible to continue trial | 0 | 0 | 7 |
| Lost to Follow-up | 0 | 0 | 14 |
| Withdrawal by Subject | 0 | 0 | 16 |
| Physician Decision | 0 | 0 | 1 |
Period III (Open-Label Stabilization)
| Stage | RISPERDAL CONSTA | Placebo | Open-Label Oral Risperidone |
|---|---|---|---|
| STARTED | 501 | 0 | 0 |
| COMPLETED | 303 | 0 | 0 |
| NOT COMPLETED | 198 | 0 | 0 |
Reasons for not completing this period:
| Reason | RISPERDAL CONSTA | Placebo | Open-Label Oral Risperidone |
|---|---|---|---|
| Death | 2 | 0 | 0 |
| Adverse Event | 12 | 0 | 0 |
| Non responder | 107 | 0 | 0 |
| Ineligible to continue trial | 5 | 0 | 0 |
| Lost to Follow-up | 19 | 0 | 0 |
| Withdrawal by Subject | 49 | 0 | 0 |
| Subject non-compliant | 1 | 0 | 0 |
| Physician Decision | 1 | 0 | 0 |
| Pregnancy | 2 | 0 | 0 |
Period IV (Double-Blind Treatment)
| Stage | RISPERDAL CONSTA | Placebo | Open-Label Oral Risperidone |
|---|---|---|---|
| STARTED | 154 | 149 | 0 |
| COMPLETED | 117 | 109 | 0 |
| NOT COMPLETED | 37 | 40 | 0 |
Reasons for not completing this period:
| Reason | RISPERDAL CONSTA | Placebo | Open-Label Oral Risperidone |
|---|---|---|---|
| Adverse Event | 1 | 1 | 0 |
| Ineligible to continue the trial | 4 | 4 | 0 |
| Lost to Follow-up | 6 | 3 | 0 |
| Withdrawal by Subject | 14 | 15 | 0 |
| Physician Decision | 10 | 14 | 0 |
| Subject Non-compliant | 2 | 1 | 0 |
| Pregnancy | 0 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intention to treat. 28 subjects from a Good Clinical Practice noncompliant site and 1 site with alleged research misconduct were excluded from efficacy analyses. The median (interquartile range) for time to relapse (d): Risperdal Consta: NA (173, NA) \& Placebo: 219 (82, NA) \[NA = not available; Risperdal Consta relapse percent \< 50% \& Placebo \<75%\]
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | RISPERDAL CONSTA | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 154 | 149 | 303 | |
| Age Continuous | years | 39.1 (SD 11.81) | 39.2 (SD 12.40) | 39.2 (SD 12.08) |
| Sex: Female, Male: Female | Participants | 79 | 68 | 147 |
| Sex: Female, Male: Male | Participants | 75 | 81 | 156 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Who Had a Mood Relapse., measured over 24 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants who had a mood relapse during a 24-month timeframe. It is a participant-level event outcome: each participant either meets the study’s definition of relapse or does not. The definition is broad. It includes meeting DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; need for specified treatment intervention; hospitalization for a bipolar mood episode; certain YMRS, MADRS, or CGI-S score thresholds; or a treatment increase or supplement judged necessary by the investigator.
A composite definition can capture clinically varied ways that a relapse may be recognized, rather than relying on a single symptom scale or one type of episode. It can also combine events that differ in severity and in how they are determined. Some criteria are based on diagnostic criteria or scale thresholds, while others depend on treatment decisions or investigator judgment. Interpretation therefore depends on knowing how each component was assessed and how events were counted. Those details are not reported in the registry record.
The registry record gives the endpoint name and definition but does not give the number of participants with relapse in either randomized arm. It therefore does not support a direct estimate of the difference between risperidone and placebo for this endpoint, nor a confidence interval describing its precision. The record also lists a median time to relapse for placebo and an unavailable median for Risperdal Consta; this is a separate time-to-event summary and does not replace the missing arm-level counts for the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison intended to evaluate prevention of mood relapse, but the posted primary endpoint information is insufficient to quantify that comparison. Although the primary endpoint is named and defined, there are no arm-level participant counts, percentages, effect estimates, confidence intervals, or p-values for relapse in the record. Without those results, the direction, magnitude, and statistical precision of the randomized treatment contrast cannot be determined.
The record does give a median time-to-relapse summary: Risperdal Consta is listed as NA (173, NA), and placebo as 219 (82, NA), with the record defining NA as not available. These entries are presented as median and interquartile range values in days. The Risperdal Consta median is unavailable, and the listed quartile values are also incomplete. The placebo median is reported, but its interquartile range is incomplete. This information does not establish a comparative effect by itself; a complete analysis would require the underlying time-to-event results and an estimate of the contrast with its uncertainty.
The primary endpoint’s composite definition includes episodes, treatment changes, hospitalizations, clinical scale thresholds, and investigator judgment. A total count would convey whether any qualifying relapse occurred, but would not show which criteria accounted for the events or whether the event types differed between groups. Component-level results are not reported in the registry record. The secondary outcomes include change in YMRS and MADRS scores, but score changes and their comparative estimates are not included in the record.
Enrollment is listed as 559, but without arm-specific denominators and outcome counts this figure cannot be used to reconstruct the primary result. The efficacy population description also notes exclusions associated with two sites, including 28 subjects from a Good Clinical Practice noncompliant site. The record does not provide a complete flow of participants or explain the effect of those exclusions on the reported analyses. Consequently, the intended intention-to-treat label cannot be independently reconciled with the stated exclusions.
The safety entries describe serious and other adverse-event counts across randomized and open-label groups, but they are not a substitute for efficacy results. The open-label entries do not provide a randomized comparison with placebo, and no causal interpretation should be attached to differences across those groups. Overall, the registry supports a description of the trial question, endpoint definition, and some safety reporting, but not a precise conclusion about the primary randomized efficacy contrast.
9. Statistical Methods Explained
Statistical interpretation begins by distinguishing an endpoint’s definition from its result. The registry record defines relapse and specifies a 24-month timeframe, but a definition does not reveal how many participants experienced the event. For a binary endpoint, the essential descriptive information is the event count and the number analyzed in each randomized group. A comparative analysis then expresses the contrast between groups using an effect measure, accompanied by uncertainty. Those arm-level counts and comparative statistics are not reported in the registry record.
What does a confidence interval convey?
General explanation: a confidence interval describes the precision of an estimated effect under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while an interval spanning effects in different directions may leave substantial uncertainty about the contrast. It is not a guarantee that the true effect lies within the particular interval. No confidence interval for the primary relapse comparison is reported in the registry record, so the precision of that comparison cannot be evaluated.
Why does the outcome definition matter?
The relapse outcome is composite: several distinct types of evidence or clinical decisions can qualify a participant as having an event. General explanation: composite endpoints can increase the range of events captured, but their interpretation depends on the components and their relative contribution. A composite result can be driven by more frequent or more subjective components, even when components differ in clinical importance. Here, the listed criteria range from diagnostic episodes and hospitalization to scale thresholds and investigator-directed treatment changes. Component counts and assessment procedures are not reported in the registry record, so the makeup of any composite result cannot be evaluated.
How should time-to-event summaries be read?
General explanation: time-to-event methods use both whether an event occurred and when it occurred. They can account for participants whose event time is not observed before follow-up ends, provided the analysis handles censoring appropriately. A median time is the point at which the estimated event-time distribution reaches its midpoint; an interquartile range describes the middle half of observed or estimated times under the method used. The registry record lists the placebo median as 219 days and the Risperdal Consta median as NA, alongside incomplete interquartile range entries. It does not describe the time-to-event method, censoring rules, or an estimated between-group contrast. These incomplete summaries cannot establish a treatment effect.
What can the planning illustrations tell readers?
General explanation: sample-size planning asks how many participants would be needed under stated assumptions to detect a chosen effect with a specified significance level and power. Such calculations depend on assumptions about the effect, variability or event frequency, allocation, and analysis. The registry record’s planning description identifies a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. It labels these calculations as planning illustrations based on the observed effect, not as the trial’s original design justification. They are not observed power and do not show how likely the trial was to detect an effect after the fact. The protocol’s own sample-size rationale is not reported in the registry record.
For binary outcomes, general planning calculations depend on the event rates assumed in each group and the size of the contrast to detect. If those inputs come from observed trial results, the illustration is conditional on those estimates and does not independently validate them. For time-to-event outcomes, calculations may instead be framed around the total number of events. The registry description distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. No additional inference about trial adequacy follows without complete endpoint results and the original design assumptions.
Why can over-dispersion matter?
General explanation: over-dispersion occurs when outcome variation is greater than a statistical model assumes. For count outcomes, failing to account for extra variation can make standard errors too small and confidence intervals too narrow. This trial’s primary endpoint is a participant-level binary event count, not a repeated count outcome, and the registry record does not report a model or evidence of over-dispersion. This general issue should not be mistaken for a stated feature of this trial’s analysis.
What can be concluded from the reported analysis methods?
The record gives the randomized design, masking description, endpoint definition, and a population note, but does not specify the primary statistical model, effect measure, missing-data method, covariate adjustment, or multiplicity procedure. Those choices can affect both the estimate and its uncertainty. In the absence of a stated analysis method and complete results, the trial’s primary estimate cannot be reproduced or independently assessed. The registry record also does not describe interim analyses or a statistical analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and three analyses, including change in YMRS scores and change in MADRS scores as secondary outcomes. The primary relapse endpoint is also described. The record does not identify which analyses correspond to each measure in enough detail to reconstruct the full testing strategy, nor does it report a multiplicity adjustment. Whether the analyses were organized into a prespecified hierarchy, whether secondary outcomes were confirmatory or exploratory, and how any repeated testing was handled are not reported in the registry record.
Multiplicity matters because testing multiple outcomes or analyses can increase the chance of at least one apparently notable result arising by chance. General explanation: procedures such as a prespecified hierarchy or adjustment can address this issue, but the appropriate approach depends on the design and inferential goals. No particular procedure should be assumed for this study. The registry record does not provide p-values for the primary endpoint or secondary outcomes, so multiplicity cannot be evaluated from the reported results.
The population description uses the term intention to treat, but it also says 28 subjects from a Good Clinical Practice noncompliant site and a site with alleged research misconduct were excluded from efficacy analyses. The exact participant flow, arm-specific analysis counts, and rationale or timing for the exclusions are not reported. The record also does not explain whether all randomized participants were included in safety analyses or how participants who discontinued were handled.
Missing-data methods are not reported in the registry record. It is not stated how missing endpoint assessments, incomplete follow-up, or censoring in the time-to-relapse summary were addressed. Nor is there a sensitivity analysis described to assess the influence of missing outcomes or site exclusions. These omissions limit assessment of the reliability and generalizability of the efficacy analyses.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| RISPERDAL CONSTA | 13 | 154 | 8.4% |
| Placebo | 25 | 149 | 16.8% |
| Open-Label Oral Risperidone | 8 | 440 | 1.8% |
| Open Label RISPERDAL CONSTA | 38 | 501 | 7.6% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| RISPERDAL CONSTA | 28 of 154 |
| Placebo | 24 of 149 |
| Open-Label Oral Risperidone | 81 of 440 |
| Open Label RISPERDAL CONSTA | 155 of 501 |
Most frequent serious adverse event terms
| Event term | Organ system | RISPERDAL CONSTA | Placebo | Open-Label Oral Risperidone | Open Label RISPERDAL CONSTA |
|---|---|---|---|---|---|
| Bipolar I disorder | Psychiatric disorders | 3 of 154 | 9 of 149 | 2 of 440 | 12 of 501 |
| Depression | Psychiatric disorders | 5 of 154 | 1 of 149 | 0 of 440 | 10 of 501 |
| Mania | Psychiatric disorders | 3 of 154 | 10 of 149 | 1 of 440 | 2 of 501 |
| Bipolar disorder | Psychiatric disorders | 0 of 154 | 1 of 149 | 1 of 440 | 2 of 501 |
| Psychotic disorder | Psychiatric disorders | 0 of 154 | 2 of 149 | 0 of 440 | 2 of 501 |
| Suicide attempt | Psychiatric disorders | 0 of 154 | 1 of 149 | 1 of 440 | 1 of 501 |
| Suicidal ideation | Psychiatric disorders | 0 of 154 | 0 of 149 | 0 of 440 | 3 of 501 |
| Major depression | Psychiatric disorders | 0 of 154 | 1 of 149 | 0 of 440 | 0 of 501 |
| Diabetes mellitus | Metabolism and nutrition disorders | 1 of 154 | 0 of 149 | 0 of 440 | 0 of 501 |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | 1 of 154 | 0 of 149 | 0 of 440 | 0 of 501 |
Most frequent non-serious adverse event terms
| Event term | Organ system | RISPERDAL CONSTA | Placebo | Open-Label Oral Risperidone | Open Label RISPERDAL CONSTA |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | 12 of 154 | 9 of 149 | 23 of 440 | 66 of 501 |
| Headache | Nervous system disorders | 11 of 154 | 10 of 149 | 33 of 440 | 28 of 501 |
| Agitation | Psychiatric disorders | 2 of 154 | 7 of 149 | 5 of 440 | 28 of 501 |
| Sommolence | Nervous system disorders | 1 of 154 | 1 of 149 | 24 of 440 | 13 of 501 |
| Anxiety | Psychiatric disorders | 4 of 154 | 6 of 149 | 6 of 440 | 23 of 501 |
| Weight increased | Investigations | 7 of 154 | 1 of 149 | 3 of 440 | 27 of 501 |
Serious events with the highest arm-level rate: mania (6.7%), bipolar i disorder (6.0%), depression (3.2%), psychotic disorder (1.3%), bipolar disorder (0.7%).
The registry lists serious adverse-event figures for RISPERDAL CONSTA, placebo, open-label oral risperidone, and open-label RISPERDAL CONSTA. The figures are participants affected and participants at risk, as recorded for each group: RISPERDAL CONSTA has 13 affected among 154 at risk, and placebo has 25 among 149 at risk. The open-label oral risperidone group has 8 affected among 440 at risk, and the open-label RISPERDAL CONSTA group has 38 among 501 at risk. The record also lists other adverse-event figures: 28 among 154 for RISPERDAL CONSTA, 24 among 149 for placebo, 81 among 440 for open-label oral risperidone, and 155 among 501 for open-label RISPERDAL CONSTA.
The open-label groups are not equivalent to the randomized arms and should not be compared with placebo as if treatment assignment were randomized between them. The registry lists serious adverse-event terms including Mania at 6.7%, Bipolar I disorder at 6.0%, Depression at 3.2%, Psychotic disorder at 1.3%, Bipolar disorder at 0.7%, and Major depression at 0.7%. These are registry safety listings, not evidence that study drug caused the events. Death figures are not reported in the registry record. Follow-up duration, event-level detail, and the methods used to classify or summarize adverse events are not reported, so the counts do not by themselves establish comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, placebo-controlled phase 3 study was conducted to examine prevention of mood episodes in bipolar 1 disorder. It identifies the intervention schedule, a broad relapse definition, and a 24-month endpoint timeframe. It also records overall enrollment and provides some safety counts. These registry entries describe the intended trial question and aspects of study conduct; they do not supply a complete efficacy result.
Most importantly, the number of participants with a primary relapse in each randomized arm is not reported in the registry record. There is no reported randomized effect estimate, confidence interval, or p-value for that endpoint. Without these, the posted results cannot quantify the size or precision of the treatment contrast. The reported time-to-relapse summary is incomplete, with the Risperdal Consta median listed as unavailable and incomplete interquartile range information for both groups. It does not fill the gap in the primary endpoint results.
The absence of those results is not evidence that the groups were the same, and it is not evidence that one treatment was superior. It means the registry information does not allow that comparison to be assessed. Likewise, the presence of adverse events in the safety listings does not establish causation, and the open-label group counts do not provide randomized comparisons.
General explanation: a trial can be randomized and carefully masked while still being difficult to interpret when results, analysis details, or participant-flow information are incomplete. Randomization helps support a fair comparison when analyses preserve the randomized groups and outcome data are adequately handled; it does not remove uncertainty created by unavailable results or unclear exclusions. Readers should distinguish what the registry records from what would require fuller trial reporting. In this case, the endpoint and design are described, but the primary efficacy comparison and several analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary endpoint combines several ways a mood relapse could be identified. A participant could qualify through a diagnostic episode, treatment intervention, hospitalization, clinical scale thresholds, or a treatment decision made by the investigator. Composite outcomes can represent a broader clinical question than a single measure, but they also make component-level reporting important. Without component counts, the overall endpoint cannot show which kinds of events contributed to the result.
The registry also illustrates why design labels and analysis details need to be read together. The study is described as randomized, parallel-group, and quadruple-masked, while its official title calls it double-blind and mentions an open-label extension. The record does not reconcile these descriptions or provide the masking procedures. The efficacy population is described as intention to treat, but exclusions related to sites are also noted. Those details matter when judging whether the analysis reflects the randomized comparison.
Another statistical issue is the difference between a trial’s own design calculations and retrospective planning illustrations. The registry’s sample-size description explicitly characterizes its calculations as illustrations based on an observed effect, rather than the original trial design. Such illustrations can help explore the assumptions needed for a future study, but they are not observed power and do not replace a protocol-based justification.
Finally, this record demonstrates that endpoint definitions and safety counts are not enough to evaluate efficacy. Arm-level primary outcome data, uncertainty estimates, analysis methods, and missing-data handling are needed for a complete statistical interpretation. Their absence makes transparency and completeness central considerations in reading the study record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central trial-specific limitation is that the registry record does not report arm-level counts for the primary relapse endpoint or a comparative estimate. Consequently, the primary efficacy contrast cannot be quantified or assessed for precision. The listed time-to-relapse summary is incomplete: the Risperdal Consta median is unavailable, and the interquartile range entries are not complete. The record does not give a time-to-event comparison or explain its method.
The participant population and analysis denominators are also unclear. Enrollment is listed as 559, but randomized, treated, and analyzed counts by arm are not reported. The efficacy population is called intention to treat, while the record states that 28 subjects from a Good Clinical Practice noncompliant site and a site with alleged research misconduct were excluded from efficacy analyses. The record does not clarify the exact scope of the exclusions, how they affected each arm, or whether sensitivity analyses were conducted.
Additional limitations include the absence of the primary statistical model, effect measure, missing-data strategy, censoring rules, multiplicity plan, and a full account of secondary outcome results. The composite endpoint includes investigator judgment and treatment decisions as well as diagnostic and scale criteria, but component-level results and assessment procedures are not reported. The record does not provide enough information to reconcile its masking descriptions or describe the open-label extension’s relation to the randomized phase.
Safety interpretation is limited by the lack of detail on follow-up, event classification, and the relationship between open-label groups and randomized participants. Death figures are not reported in the registry record. These limitations concern the completeness of the available record; they do not establish that the original trial lacked such analyses or procedures.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes — NCT00132678.
- Registry record last updated 2013-07-29; status last verified 2013-07.
- Results first posted 2009-02-27.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00132678 is a completed phase 3 randomized, parallel-group study of long-acting intramuscular risperidone versus matching placebo for prevention of mood episodes in bipolar 1 disorder. Enrollment is listed as 559. The primary endpoint was the number of participants with a defined mood relapse over 24 months. The record describes injection schedules, secondary YMRS and MADRS outcomes, an open-label extension, and safety groups.
The registry record does not report arm-level results for the primary relapse endpoint, a comparative efficacy estimate, or its uncertainty. It gives incomplete time-to-relapse summaries and notes exclusions from efficacy analyses associated with sites. Safety listings include serious and other adverse events in randomized and open-label groups, but do not establish causation or provide a randomized comparison across all groups. Several analysis and missing-data details are not reported in the registry record.