Background: This study evaluates the long-term efficacy of aripiprazole compared to placebo in children with bipolar disorders.
Method: Outpatients aged 4 to 9 years meeting DSM-IV criteria for a bipolar disorder (I, II, not otherwise specified, cyclothymia) were eligible to receive up to 16 weeks of open-label treatment with aripiprazole (phase 1). Patients were randomized into the 72-week double-blind phase of the study once they met a priori response criteria for stabilization (phase 2). During phase 2, patients either remained on their current aripiprazole regimen or began a double-blind taper with aripiprazole discontinued and switched to placebo. The primary outcome measure for phase 2 was time to discontinuation due to a mood event.
Results: Patients were recruited between May 2004 and November 2008. Following phase 1, in which 96 patients received aripiprazole, 30 patients (mean age = 7.1 years) were randomly assigned to continue aripiprazole and 30 patients (mean age = 6.7 years) were randomly assigned to placebo. The mean (SD) dose of aripiprazole prior to randomization for these patients was 6.4 (2.1) mg/d. Patients randomly assigned to aripiprazole were enrolled significantly longer until time to study discontinuation due to a mood event (6.14 median weeks, SE ± 11.88 weeks; P = .005) and discontinuation for any reason (including mood events) (4.00 median weeks, SE ± 3.91 weeks; P = .003) than those randomly assigned to placebo (mood event, 2.29 median weeks, SE ± 0.38 weeks; any reason, 2.00 median weeks, SE ± 0.31 weeks). Regardless of random assignment, both the aripiprazole and placebo groups showed substantial rates of withdrawal from maintenance treatment over the initial 4 weeks (15/30 [50%] for aripiprazole; 27/30 [90%] for placebo), suggesting a possible nocebo effect (ie, knowledge of possibly switching from active medication to placebo increasing concern about relapse). The most frequently reported adverse events during double-blind aripiprazole therapy included stomach pain (n = 10, 33%), increased appetite (n = 9, 30%), and headaches (n = 9, 30%).
Conclusions: Despite the possibility of a nocebo effect, these results suggest that aripiprazole may be superior to placebo in the long-term treatment of pediatric patients following stabilization with open-label aripiprazole.
Trial Registration: clinicaltrials.gov Identifier: NCT00194077.
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http://dx.doi.org/10.4088/JCP.11m07104 | DOI Listing |
CNS Drugs
January 2025
Department of Cardiology, Second Affiliated Hospital of Dalian Medical University, Dalian, China.
Background: Early neurological deterioration (END) is associated with a poor prognosis in acute ischemic stroke (AIS). Effectively lowering low-density lipoprotein cholesterol (LDL-C) can improve the stability of atherosclerotic plaque and reduce post-stroke inflammation, which may be an effective means to lower the incidence of END. The objective of this study was to determine the preventive effects of evolocumab on END in patients with non-cardiogenic AIS.
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January 2025
Department of Sport Injuries and Corrective Exercises, Faculty of Physical Education and Sport Sciences, Shahid Bahonar University of Kerman, Kerman, Iran.
Individuals with intellectual disabilities (ID) often exhibit lower levels of physical fitness compared to the general population, including reduced strength, endurance, flexibility, and coordination. Dynamic neuromuscular stabilization (DNS) training can potentially improve the performance of adults with ID caused by weak motor skills due to a lack of desirable nerve growth during childhood and before puberty. Also, DNS training proposed to improve physical fitness in this population, but the effectiveness and durability of DNS training on specific fitness components have not been well-established.
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January 2025
Department of Endodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.
The preservation of the original configurations of root canals during endodontic preparation is crucial for treatment success. Nickel-titanium (NiTi) rotary systems have been refined to optimize canal shaping while minimizing iatrogenic errors. This study aimed to evaluate and compare the shaping efficacy of the novel R-Motion (RM) and the established WaveOne Gold (WG) systems using micro-computed tomography (micro-CT).
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January 2025
Department of Critical Care Medicine, Tongde Hospital of Zhejiang Province, #234 Gucui Road, Hangzhou, 310012, Zhejiang, People's Republic of China.
The intestinal barrier function is a critical defense mechanism in the human body, serving as both the primary target and initiating organ in cases of sepsis. Preserving the integrity of this barrier is essential for preventing complications and diseases, including sepsis and mortality. Despite this importance, the impact of resveratrol on intestinal barrier function remains unclear.
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January 2025
Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
Introduction: Ultrasound is important in heart diagnostics, yet implementing effective cardiac ultrasound requires training. While current strategies incorporate digital learning and ultrasound simulators, the effectiveness of these simulators for learning remains uncertain. This study evaluates the effectiveness of simulator-based versus human-based training in Focused Assessed with Transthoracic Echocardiography (FATE).
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