Table 1.
Characteristics and study design of the reviewed studies on once-monthly paliperidone palmitate
| Author, year | Topic | Sample (n) | Study design | Aims | Severity of patients | Comparison groups |
|---|---|---|---|---|---|---|
| Hough et al 200917 | Efficacy, safety, tolerability, and preference | 252 | 25-week randomized, multicenter, cross-over trial | To evaluate the safety and tolerability of PP in the injection sites (deltoid – gluteus) | Mild Adults with stable schizophrenia |
1:1:1 PP 50 mg eq PP 75 mg eq PP 100 mg eq |
| Hough et al 201018 | Efficacy, safety, and tolerability | 849 | Two phases 9-week open label Randomized, double-blind, placebo-controlled trial |
To assess efficacy and tolerability of PP in delaying time-to-relapse | Mild Schizophrenia patients |
1:1 PP Placebo |
| Nasrallah et al 201019 | Efficacy, safety, and tolerability | 514 | 13-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose–response study | To assess the efficacy and safety of three fixed doses of PP | Mild Schizophrenia patients |
1:1:1:1 PP 25 mg eq PP 50 mg eq PP 100 mg eq Placebo |
| Pandina et al 201020 | Efficacy and safety | 652 | 13-week randomized, double-blind, placebo-controlled multicenter study | To assess the efficacy and safety of higher doses of PP | Acute patients | 1:1:1:1 PP 25 mg eq PP 100 mg eq PP 150 mg eq Placebo |
| Alphs et al 201121 | Efficacy, safety, and tolerability | 312 | Post hoc analysis of a 13-week randomized, double-blind, placebo- controlled, multicenter clinical trial | To assess onset of efficacy and tolerability | Acute (markedly to severely ill) | 1:1:1:1 PP 25 mg eq PP 100 mg eq PP 150 mg eq Placebo |
| Bossie et al 2011a22 | Efficacy and tolerability | 652 | Post hoc analysis of a 13-week randomized, double-blind, placebo-controlled, clinical trial | To examine the tolerability of the initiation doses for PP and efficacy | Acute, mild | 1:1:1:1 PP 25 mg eq PP 100 mg eq PP 150 mg eq Placebo |
| Bossie et al 2011b23 | Efficacy and tolerability | 652 | 13-week randomized, double- blind, placebo-controlled, clinical trial | To investigate the time of onset of efficacy and tolerability of PP | Mild | 1:1:1:1 PP 25 mg eq PP 100 mg eq PP 150 mg eq Placebo |
| Li et al 201124 | Efficacy, safety, and tolerability | 452 | 13-week open-label, rater-blinded, parallel-group, noninferiority study | To evaluate the noninferiority of PP to RLAI | Acute | 1:1 PP (flexible doses, 50–150 mg eq) RLAI (25–50 mg) |
| Pandina et al 201125 | Efficacy, safety, and tolerability | 1,220 | 13-week randomized, double-blind, double-dummy, active-controlled, parallel-group multicenter noninferiority comparative study | To assess noninferiority of PP versus RLAI | Acute | 1:1 PP flexible dosing (50–150 mg eq) RLAI (25–50 mg) |
| Coppola et al 201230 | Safety and tolerability | 212 | 1-year open-label, long-term prospective, multiple-dose, multicenter study | To evaluate the long-term safety and tolerability of PP 150 mg eq | Mild | Treatment A (fixed doses of PP 150 mg eq) Treatment B (50–150 mg eq) |
| Sliwa et al 201231 | Efficacy and tolerability | 645 | Post hoc analysis from an open- label, double-blind, multiphase trial First phase: 9 weeks Second phase: 24 weeks |
To investigate long-term tolerability according to duration of illness | Mild-severe | Recently diagnosed Chronic ill Flexible dosing |
| Fleischhacker et al 201226 | Efficacy, safety, and tolerability | 749 | 53-week double-blind, noninferiority trial | To assess the safety and tolerability of PP in maintenance therapy | Acute | 1:1 PP flexible dosing RLAI |
| Alphs et al 201327 | Efficacy and tolerability | 747 | Post hoc analysis of a 13-week randomized, double-blind clinical trial | To evaluate clinical response to treatment with PP and RLAI | Mild | 1:1 PP RLAI |
| Fu et al 201428 | Efficacy, safety, and tolerability | 334 | Post hoc safety and efficacy analyses of a 13-week, double- blind, double-dummy, multicenter comparative study | To compare efficacy and tolerability of PP with oral risperidone (and RLAI) during the first month of treatment | Mild | 1:1 PP (50–150 mg eq) RLAI (25–50 mg eq) |
| Gopal et al 201429 | Safety and tolerability | 4,357 | 6-month, post hoc analysis of randomized, controlled, long-term, clinical research studies | To determine the incidence of tardive dyskinesia in PP and PER | Mild | 1:1 PP (25–150 mg eq) PER (3–15 mg) |
| Schreiner et al 201432 | Efficacy, safety, and tolerability | 593 | 6-month prospective flexible- dose, interventional, single-arm, international, unblinded | To explore the tolerability, safety, and treatment response | Nonacute symptomatic | PP (50–150 mg eq) |
| Alphs et al 201433 Mao et al 201445 |
Efficacy, safety, and tolerability | 450 | 15-month, randomized, active- controlled, open-label, board-blinded, parallel-group, flexible-dose, multicenter study | To assess the efficacy, safety, and tolerability of PP in both explanatory and pragmatic approaches | Severe | PP versus oral antipsychotics |
| Hargarter et al 201534 | Efficacy, safety, and tolerability | 212 | 6-month prospective, multicenter, nonrandomized, single-arm, open-label study | To explore treatment outcomes and suggest recommendations for use of PP | Acute | PP (50–150 mg eq) |
| Zhang et al 201535 | Efficacy and safety | 521 | 18-month, nonrandomized, single- arm, open-label, mirror-designed, multicenter, Phase-IIIb study | To assess the effectiveness and safety of PP and impact on hospitalization in patients previously treated with oral AP | Mild-severe | PP (50 mg eq, 75 mg eq, 100 mg eq, or 150 mg eq; flexible dosing) |
Abbreviations: AP, antipsychotics; PER, paliperidone extended release; PP, paliperidone palmitate; RLAI, risperidone long-acting injection.