Trial · NCT00391222
A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder
NCT00391222, Phase 3, Completed, Janssen Pharmaceutica N.V., Belgium; results first posted 2010-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder. Trials, record NCT00391222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00391222
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder
- NCT number
- NCT00391222
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 585 participants, actual
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Conditions
- Bipolar Disorder
- Interventions
- Olanzapine, Placebo, Risperidone Long Acting Injectable (LAI)
- First posted
- 2006-10-23
- Last updated
- 2014-05-09
- Results first posted
- 2010-11-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo) | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) \>12 or Montgomery-Åsberg Depression Rating Scale (MADRS) \>12 combined with Clinical Global Impression - Severity (CGI-S) \>=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer. |
| Secondary | Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of an elevated mood episode was estimated by means of the same survival analysis method as for the primary outcome. |
| Secondary | Time to Recurrence of a Depressive Episode | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of a depressive episode was estimated by means of the same survival analysis method as for the primary outcome. |
| Secondary | Time to Early Study Discontinuation for Any Reason | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | The robustness of the primary outcome analysis was tested by means of a sensitivity analysis: patients who discontinued the study during Period III for any reason were analyzed as having a recurrence of a mood episode at the time of their study discontinuation. The same survival analysis method as for the primary outcome was applied. |
| Secondary | Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS) | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | The 11-item YMRS was administered by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. A severity rating was assigned to each of the items, based on the patient's subjective report of his or her condition over the previous 7 days or since the last visit (whichever was shorter) and the clinician's behavioral observations during the interview, with emphasis on the latter. The total YMRS score included the score of all 11 items ranging from 0 to 60, a higher score indicating a more severe condition. |
| Secondary | Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS) | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | The MADRS was assessed by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. The scale consists of 10 items that cover all of the core depressive symptoms. Each item is scored from 0 to 6 and a total score is calculated by adding the scores of all 10 items. For each individual item as well as for the total score, a higher score represents a more severe condition. |
| Secondary | Time to Recurrence of a Mood Episode (Exploratory/Olanzapine) | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | Recurrence was defined as for the risperidone LAI and placebo arms (meeting any of 5 criteria). Since the study was designed to compare the efficacy of risperidone LAI versus placebo, this olanzapine analysis was exploratory in nature. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo) | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent). | days | MEAN |
| SECONDARY | Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent). | days | MEAN |
| SECONDARY | Time to Recurrence of a Depressive Episode | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent). | days | MEAN |
| SECONDARY | Time to Early Study Discontinuation for Any Reason | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent). | days | MEAN |
| SECONDARY | Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS) | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent). | units on a scale | MEAN |
| SECONDARY | Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS) | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent). | units on a scale | MEAN |
| SECONDARY | Time to Recurrence of a Mood Episode (Exploratory/Olanzapine) | Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier) | ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 1 patient in the olanzapine arm (discontinued the study due to non-compliance to the study medication). | days | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo) | Risperidone LAI | 293.39 | Standard Error 15.93 | days | |
| Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo) | Placebo | 270.47 | Standard Error 17.74 | days | |
| Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode | Risperidone LAI | 357.41 | Standard Error 13.94 | days | |
| Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode | Placebo | 323.14 | Standard Error 18.57 | days | |
| Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode | Olanzapine | 448.03 | Standard Error 12.42 | days | |
| Time to Recurrence of a Depressive Episode | Risperidone LAI | 213.86 | Standard Error 7.23 | days | |
| Time to Recurrence of a Depressive Episode | Placebo | 300.20 | Standard Error 10.64 | days | |
| Time to Recurrence of a Depressive Episode | Olanzapine | 356.11 | Standard Error 7.63 | days | |
| Time to Early Study Discontinuation for Any Reason | Risperidone LAI | 252.45 | Standard Error 15.87 | days | |
| Time to Early Study Discontinuation for Any Reason | Placebo | 236.14 | Standard Error 16.02 | days |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period II (Open-label Risperidone LAI) | STARTED | Risperidone LAI | 0 | |
| Period II (Open-label Risperidone LAI) | STARTED | Placebo | 0 | |
| Period II (Open-label Risperidone LAI) | STARTED | Olanzapine | 0 | |
| Period II (Open-label Risperidone LAI) | STARTED | Open-label Risperidone LAI | 560 | |
| Period II (Open-label Risperidone LAI) | COMPLETED | Risperidone LAI | 0 | |
| Period II (Open-label Risperidone LAI) | COMPLETED | Placebo | 0 | |
| Period II (Open-label Risperidone LAI) | COMPLETED | Olanzapine | 0 | |
| Period II (Open-label Risperidone LAI) | COMPLETED | Open-label Risperidone LAI | 398 | |
| Period II (Open-label Risperidone LAI) | NOT COMPLETED | Risperidone LAI | 0 | |
| Period II (Open-label Risperidone LAI) | NOT COMPLETED | Placebo | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events224
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Agitation | Psychiatric disorders | Risperidone LAI | 3 | 132 | |
| other | Agitation | Psychiatric disorders | Placebo | 6 | 135 | |
| other | Agitation | Psychiatric disorders | Olanzapine | 6 | 131 | |
| other | Agitation | Psychiatric disorders | Open-label Risperidone LAI | 25 | 560 | |
| other | Akathisia | Nervous system disorders | Risperidone LAI | 5 | 132 | |
| other | Akathisia | Nervous system disorders | Placebo | 1 | 135 | |
| other | Akathisia | Nervous system disorders | Olanzapine | 6 | 131 | |
| other | Akathisia | Nervous system disorders | Open-label Risperidone LAI | 38 | 560 | |
| other | Amenorrhoea | Reproductive system and breast disorders | Risperidone LAI | 11 | 132 | |
| other | Amenorrhoea | Reproductive system and breast disorders | Placebo | 3 | 135 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Risperidone LAI | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Olanzapine | ||
| Total, all-cause mortality | Open-label Risperidone LAI | ||
| Total, other adverse events | Risperidone LAI | 90 | 132 |
| Total, other adverse events | Placebo | 77 | 135 |
| Total, other adverse events | Olanzapine | 96 | 131 |
| Total, other adverse events | Open-label Risperidone LAI | 326 | 560 |
| Total, serious adverse events | Risperidone LAI | 19 | 132 |
| Total, serious adverse events | Placebo | 32 | 135 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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