Phase 3
Completed N=440
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
Source: ClinicalTrials.gov NCT00132678 ↗Enrolled (actual)
440
Serious AEs
6.8%
Results posted
Feb 2009
Primary outcomePrimary: Number of Participants Who Had a Mood Relapse. — 42; 76; 98; 59 Participants — p=<0.001
Summary
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had a Mood Relapse. |
42; 76; 98; 59 | <0.001 sig |
| SECONDARY Change in Young Mania Rating Scale (YMRS) Scores. |
2.9; 9.1 | <0.001 sig |
| SECONDARY Change in Montgomery-Åsberg Depression Rating Scale (MADRS) |
2.8; 4.9 | 0.020 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable
- Two or more bipolar mood episodes in the last 2 years excluding current episode
- Negative pregnancy test
Exclusion Criteria
- History of > than 4 mood episodes a year during the last two years
- patients experiencing a depressive episode
- History of antisocial or borderline personality illness
- Has unstable or serious general medical illness
- Has received medications disallowed by study criteria.
Data sourced from ClinicalTrials.gov (NCT00132678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.