Abstract | OBJECTIVE: METHODS: RESULTS: Among 622 randomized patients, no clinically relevant changes from baseline to week 12 were observed for any serum lipid, lipoprotein, plasma glucose, or HbA1c value with placebo or either dose of aripiprazole lauroxil. Both doses of aripiprazole lauroxil were associated with reductions in mean prolactin levels, whereas placebo treatment was not. The mean (standard deviation) change from baseline for body weight was 0.74 (3.9) kg, 0.86 (3.7) kg, and 0.01 (3.6) kg for aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, and placebo groups, respectively. AEs related to metabolic parameters were reported in 2.4%, 1.4%, and 2.4% of patients in the aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, and placebo groups, respectively. CONCLUSIONS: TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01469039.
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Authors | Henry A Nasrallah, John W Newcomer, Robert Risinger, Yangchun Du, Jacqueline Zummo, Anjana Bose, Srdjan Stankovic, Bernard L Silverman, Elliot W Ehrich |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 77
Issue 11
Pg. 1519-1525
(Nov 2016)
ISSN: 1555-2101 [Electronic] United States |
PMID | 27574838
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © Copyright 2016 Physicians Postgraduate Press, Inc. |
Chemical References |
- Blood Glucose
- Delayed-Action Preparations
- Glycated Hemoglobin A
- Lipids
- Lipoproteins
- Aripiprazole
- Prolactin
- aripiprazole lauroxil
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Topics |
- Acute Disease
- Adolescent
- Adult
- Aged
- Aripiprazole
(adverse effects, therapeutic use)
- Blood Glucose
(metabolism)
- Body Weight
(drug effects)
- Delayed-Action Preparations
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Injections, Intramuscular
- Lipids
(blood)
- Lipoproteins
(blood)
- Male
- Middle Aged
- Prolactin
(blood)
- Risk
- Schizophrenia
(blood, diagnosis, drug therapy)
- Schizophrenic Psychology
- Young Adult
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