TY - JOUR
T1 - A randomized, double-blind, placebo-controlled trial to assess prevention of mood episodes with risperidone long-acting injectable in patients with bipolar I disorder
AU - Vieta, Eduard
AU - Montgomery, Stuart
AU - Sulaiman, Ahmad Hatim
AU - Cordoba, Rodrigo
AU - Huberlant, Benedicte
AU - Martinez, Lupe
AU - Schreiner, Andreas
N1 - Funding Information:
The study was funded by Janssen EMEA. Janssen EMEA participated in study design, data collection, analysis and interpretation of data, in the writing of the report and in the decision to submit the paper for publication. Analysis, interpretation of data and writing the report was done with the help of a third party (SGS Life Science Services). Editorial support with drafting and completion of the manuscript was provided by Daniel Booth (Bioscript Stirling Ltd.) and funded by Janssen EMEA.
Funding Information:
Eduard Vieta has received grants and served as consultant, advisor or speaker for the following entities: Almirall, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Forest Research Institute, Glaxo-Smith-Kline, Janssen-Cilag, Jazz, Lundbeck, Merck, Novartis, Organon, Otsuka, Pfizer, Pierre-Fabre, Qualigen, Sanofi-Aventis, Servier, Shering-Plough, Solvay, Takeda, the Spanish Ministry of Science and Innovation (CIBERSAM), the Seventh European Framework Programme (ENBREC), the Stanley Medical Research Institute, United Biosource Corporation, and Wyeth. Stuart Montgomery has received honoraria from and/or participated in advisory boards for AstraZeneca, Bionevia, Bristol Myers Squibb, GlaxoSmithKline, Grunenthal, Johnson & Johnson, Lilly, Lundbeck, Merck, Merz, M's Science, Neurim, Otsuka, Pierre Fabre, Pfizer, Pharmaneuroboost, Richter, Roche, Sanofi, Sepracor, Servier, Shire, Synosis, Takeda, Theracos, Targacept, Transcept, UBC, Xytis and Wyeth. Ahmad Hatim Sulaiman has received grants, participated in advisory boards and/or spoken for Astra Zeneca, Danipone Sumitomo, Eli Lilly, Janssen Cilag, Lundbeck, Otsuka, Pfizer, Sanofi Aventis, Servier, Takeda, United Biosource Coproration and Wyeth. Rodrigo Córdoba has served as advisor or speaker for the following entities: AstraZeneca, Bristol Myers Squibb, Ely Lilly, Glaxo-Smith-Kline, Janssen-Cilag, Lundbeck, Merck, Organon, Pfizer, Sanofy-Aventis, Schering-Plough, and Wyeth. Benedicte Huberlante is an employee of SGS–Life Science Services, a company employed by Janssen–Cilag EMEA to provide statistical analysis. Andreas Schreiner and Lupe Martinez are employees of Janssen–Cilag EMEA.
PY - 2012/11
Y1 - 2012/11
N2 - The efficacy and safety of risperidone long-acting injectable (LAI) for preventing recurrence of mood episodes in patients with bipolar I disorder was evaluated in a randomized, placebo-controlled study. After a 12-week open-label period with risperidone LAI (n=560), patients who did not experience a recurrence entered an 18-month randomized, double-blind period with risperidone LAI (n=132) or placebo (n=135); a third treatment arm (n=131) was randomized to oral olanzapine (10. mg/day) for reference and exploratory comparisons. The primary efficacy endpoint was time to recurrence of any mood episode for risperidone LAI versus placebo in the double-blind period (Kaplan-Meier analysis). Additional efficacy endpoints included Young Mania Rating Scale, Montgomery-Asberg Depression Rating Scale and Clinical Global Impression. During the double-blind period, dosing was fixed at patients' final open-label dose (25. mg, 66% of patients; 37.5. mg, 31%; 50. mg, 4%). The primary outcome demonstrated a median time to mood episode recurrence of 198 day in the placebo arm, whereas the median was not reached in the risperidone LAI arm (p=0.057). Time to recurrence of any mood episode was significantly longer with risperidone LAI versus placebo (log-rank test stratified by region only, p=0.031); the difference was significant for time to recurrence of elevated mood episodes (p=0.005) but not depressive episodes (p=0.655). Significant improvement of manic symptoms and global condition versus placebo were observed for risperidone LAI, with no evidence of worsening of depression. In conclusion, risperidone LAI significantly delayed time to recurrence of elevated mood episodes, with a safety profile consistent with previous studies.
AB - The efficacy and safety of risperidone long-acting injectable (LAI) for preventing recurrence of mood episodes in patients with bipolar I disorder was evaluated in a randomized, placebo-controlled study. After a 12-week open-label period with risperidone LAI (n=560), patients who did not experience a recurrence entered an 18-month randomized, double-blind period with risperidone LAI (n=132) or placebo (n=135); a third treatment arm (n=131) was randomized to oral olanzapine (10. mg/day) for reference and exploratory comparisons. The primary efficacy endpoint was time to recurrence of any mood episode for risperidone LAI versus placebo in the double-blind period (Kaplan-Meier analysis). Additional efficacy endpoints included Young Mania Rating Scale, Montgomery-Asberg Depression Rating Scale and Clinical Global Impression. During the double-blind period, dosing was fixed at patients' final open-label dose (25. mg, 66% of patients; 37.5. mg, 31%; 50. mg, 4%). The primary outcome demonstrated a median time to mood episode recurrence of 198 day in the placebo arm, whereas the median was not reached in the risperidone LAI arm (p=0.057). Time to recurrence of any mood episode was significantly longer with risperidone LAI versus placebo (log-rank test stratified by region only, p=0.031); the difference was significant for time to recurrence of elevated mood episodes (p=0.005) but not depressive episodes (p=0.655). Significant improvement of manic symptoms and global condition versus placebo were observed for risperidone LAI, with no evidence of worsening of depression. In conclusion, risperidone LAI significantly delayed time to recurrence of elevated mood episodes, with a safety profile consistent with previous studies.
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U2 - 10.1016/j.euroneuro.2012.03.004
DO - 10.1016/j.euroneuro.2012.03.004
M3 - Research Article
C2 - 22503488
AN - SCOPUS:84867497590
SN - 0924-977X
VL - 22
SP - 825
EP - 835
JO - European Neuropsychopharmacology
JF - European Neuropsychopharmacology
IS - 11
ER -