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Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study.
Schizophr Res. 2010 Feb; 116(2-3):107-17.SR

Abstract

OBJECTIVE

We assessed efficacy and tolerability of the injectable atypical antipsychotic paliperidone palmitate in delaying time-to-relapse in adults with schizophrenia.

METHODS

Eligible patients (Positive and Negative Syndrome Scale [PANSS] total score < 120) were transitioned from previous antipsychotics to paliperidone palmitate during a 9-week, open-label phase. Patients received the first 2 intramuscular injections of paliperidone palmitate (50mg eq) one-week apart, then subsequent injections (25, 50, or 100mg eq, flexibly-dosed), once-monthly. Stable patients (PANSS total score < or = 75) continued into the 24-week maintenance phase. At maintenance phase endpoint, stabilized patients were randomized (1:1 ratio) to either continue paliperidone palmitate (at stabilized dose) or begin placebo in the variable-duration, double-blind phase.

RESULTS

The preplanned interim analysis (conducted after 68 relapse events) included 312 patients: mean age = 40 years, 55% men, 66% white, and mean transition baseline PANSS total score (SD): placebo, 69.5 (16.89); paliperidone palmitate, 69.3 (17.39). Time-to-relapse (primary endpoint) favored paliperidone palmitate (p<0.0001, log-rank test) at interim and final analysis (n=408). The hazard ratio (placebo/paliperidone palmitate) at the final analysis was 3.60 (95% CI: 2.45, 5.28). Treatment-emergent adverse event rates (final analysis set) were: 67% for transition and maintenance phases, and 45% (placebo) and 44% (paliperidone palmitate) for the double-blind phase. Across phases, the incidence of glucose-related adverse events was low (< or = 4%), while mean weight increased by 1.9 kg for paliperidone palmitate and remained unchanged for placebo patients. Injection site tolerability was comparable between groups.

CONCLUSION

Paliperidone palmitate significantly delayed time-to-relapse compared with placebo and presented no new safety signals.

Authors+Show Affiliations

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, USA. DHough2@its.jnj.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19959339

Citation

Hough, David, et al. "Paliperidone Palmitate Maintenance Treatment in Delaying the Time-to-relapse in Patients With Schizophrenia: a Randomized, Double-blind, Placebo-controlled Study." Schizophrenia Research, vol. 116, no. 2-3, 2010, pp. 107-17.
Hough D, Gopal S, Vijapurkar U, et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res. 2010;116(2-3):107-17.
Hough, D., Gopal, S., Vijapurkar, U., Lim, P., Morozova, M., & Eerdekens, M. (2010). Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophrenia Research, 116(2-3), 107-17. https://doi.org/10.1016/j.schres.2009.10.026
Hough D, et al. Paliperidone Palmitate Maintenance Treatment in Delaying the Time-to-relapse in Patients With Schizophrenia: a Randomized, Double-blind, Placebo-controlled Study. Schizophr Res. 2010;116(2-3):107-17. PubMed PMID: 19959339.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. AU - Hough,David, AU - Gopal,Srihari, AU - Vijapurkar,Ujjwala, AU - Lim,Pilar, AU - Morozova,Margarita, AU - Eerdekens,Mariëlle, Y1 - 2009/12/02/ PY - 2009/08/25/received PY - 2009/10/26/revised PY - 2009/10/28/accepted PY - 2009/12/5/entrez PY - 2009/12/5/pubmed PY - 2010/4/14/medline SP - 107 EP - 17 JF - Schizophrenia research JO - Schizophr Res VL - 116 IS - 2-3 N2 - OBJECTIVE: We assessed efficacy and tolerability of the injectable atypical antipsychotic paliperidone palmitate in delaying time-to-relapse in adults with schizophrenia. METHODS: Eligible patients (Positive and Negative Syndrome Scale [PANSS] total score < 120) were transitioned from previous antipsychotics to paliperidone palmitate during a 9-week, open-label phase. Patients received the first 2 intramuscular injections of paliperidone palmitate (50mg eq) one-week apart, then subsequent injections (25, 50, or 100mg eq, flexibly-dosed), once-monthly. Stable patients (PANSS total score < or = 75) continued into the 24-week maintenance phase. At maintenance phase endpoint, stabilized patients were randomized (1:1 ratio) to either continue paliperidone palmitate (at stabilized dose) or begin placebo in the variable-duration, double-blind phase. RESULTS: The preplanned interim analysis (conducted after 68 relapse events) included 312 patients: mean age = 40 years, 55% men, 66% white, and mean transition baseline PANSS total score (SD): placebo, 69.5 (16.89); paliperidone palmitate, 69.3 (17.39). Time-to-relapse (primary endpoint) favored paliperidone palmitate (p<0.0001, log-rank test) at interim and final analysis (n=408). The hazard ratio (placebo/paliperidone palmitate) at the final analysis was 3.60 (95% CI: 2.45, 5.28). Treatment-emergent adverse event rates (final analysis set) were: 67% for transition and maintenance phases, and 45% (placebo) and 44% (paliperidone palmitate) for the double-blind phase. Across phases, the incidence of glucose-related adverse events was low (< or = 4%), while mean weight increased by 1.9 kg for paliperidone palmitate and remained unchanged for placebo patients. Injection site tolerability was comparable between groups. CONCLUSION: Paliperidone palmitate significantly delayed time-to-relapse compared with placebo and presented no new safety signals. SN - 1573-2509 UR - https://www.unboundmedicine.com/medline/citation/19959339/Paliperidone_palmitate_maintenance_treatment_in_delaying_the_time_to_relapse_in_patients_with_schizophrenia:_a_randomized_double_blind_placebo_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0920-9964(09)00549-0 DB - PRIME DP - Unbound Medicine ER -