Abstract | IMPORTANCE: OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: Multisite, double-blind, randomized clinical trial conducted from March 2011 to July 2013 at 22 US clinical research sites. Randomized patients (n = 311) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a long-acting injectable antipsychotic. INTERVENTIONS: MAIN OUTCOME MEASURES: Efficacy failure, defined as a psychiatric hospitalization, a need for crisis stabilization, a substantial increase in frequency of outpatient visits, a clinician's decision that oral antipsychotic could not be discontinued within 8 weeks after starting the long-acting injectable antipsychotics, or a clinician's decision to discontinue the assigned long-acting injectable due to inadequate therapeutic benefit. Key secondary outcomes were common adverse effects of antipsychotic medications. RESULTS: There was no statistically significant difference in the rate of efficacy failure for paliperidone palmitate compared with haloperidol decanoate (adjusted hazard ratio, 0.98; 95% CI, 0.65-1.47). The number of participants who experienced efficacy failure was 49 (33.8%) in the paliperidone palmitate group and 47 (32.4%) in the haloperidol decanoate group. On average, participants in the paliperidone palmitate group gained weight and those in the haloperidol decanoate group lost weight; after 6 months, the least-squares mean weight change for those taking paliperidone palmitate was increased by 2.17 kg (95% CI, 1.25-3.09) and was decreased for those taking haloperidol decanoate (-0.96 kg; 95% CI, -1.88 to -0.04). Patients taking paliperidone palmitate had significantly higher maximum mean levels of serum prolactin (men, 34.56 µg/L [95% CI, 29.75-39.37] vs 15.41 µg/L [95% CI, 10.73-20.08]; P <.001, and for women, 75.19 [95% CI, 63.03-87.36] vs 26.84 [95% CI, 13.29-40.40]; P<.001). Patients taking haloperidol decanoate had significantly larger increases in global ratings of akathisia (0.73 [95% CI, 0.59-0.87] vs 0.45 [95% CI, 0.31-0.59]; P=.006). CONCLUSIONS AND RELEVANCE: TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01136772.
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Authors | Joseph P McEvoy, Matthew Byerly, Robert M Hamer, Rosalie Dominik, Marvin S Swartz, Robert A Rosenheck, Neepa Ray, J Steven Lamberti, Peter F Buckley, Tania M Wilkins, T Scott Stroup |
Journal | JAMA
(JAMA)
Vol. 311
Issue 19
Pg. 1978-87
(May 21 2014)
ISSN: 1538-3598 [Electronic] United States |
PMID | 24846035
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Antipsychotic Agents
- Isoxazoles
- Palmitates
- haloperidol decanoate
- Haloperidol
- Paliperidone Palmitate
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Topics |
- Adult
- Akathisia, Drug-Induced
- Antipsychotic Agents
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Haloperidol
(administration & dosage, adverse effects, analogs & derivatives)
- Hospitalization
- Humans
- Injections, Intramuscular
- Isoxazoles
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Paliperidone Palmitate
- Palmitates
(adverse effects, therapeutic use)
- Schizophrenia
(drug therapy)
- Treatment Failure
- Treatment Outcome
- Weight Gain
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