Review of the efficacy of placebo in comparative clinical trials between typical and atypical antipsychotics

Oliveira, Irismar Reis de; Nunes, Paulo Menezes; Coutinho, Domingos Macedo; Sena, Eduardo Pondé de

doi:10.1590/s1516-44462009000100013

Cited by 7 publications

(5 citation statements)

References 33 publications

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“…However, we noted a 43% improvement in manic symptoms in the individuals with BSD treated with Vitamin D 3 , which compares favorably with the 20% improvement usually seen with placebo (Oliveira et al 2009). We also had a relatively small sample size.…”

Section: Limitations and Future Considerationssupporting

confidence: 54%

Vitamin D₃Supplemental Treatment for Mania in Youth with Bipolar Spectrum Disorders

Sikoglu

Navarro

Starr

et al. 2015

Journal of Child and Adolescent Psychopharmacology

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Objective: We aimed to determine the effect of an open-label 8 week Vitamin D 3 supplementation on manic symptoms, anterior cingulate cortex (ACC) glutamate, and c-aminobutyric acid (GABA) in youth exhibiting symptoms of mania; that is, patients with bipolar spectrum disorders (BSD). We hypothesized that an 8 week Vitamin D 3 supplementation would improve symptoms of mania, decrease ACC glutamate, and increase ACC GABA in BSD patients. Single time point metabolite levels were also evaluated in typically developing children (TD). Methods: The BSD group included patients not only diagnosed with BD but also those exhibiting bipolar symptomology, including BD not otherwise specified (BD-NOS) and subthreshold mood ratings (Young Mania Rating Scale [YMRS] ‡ 8 and Clinical Global Impressions -Severity [CGI-S] ‡ 3). Inclusion criteria were: male or female participants, 6-17 years old. Sixteen youth with BSD exhibiting manic symptoms and 19 TD were included. BSD patients were asked to a take daily dose (2000 IU) of Vitamin D 3 (for 8 weeks) as a supplement. Neuroimaging data were acquired in both groups at baseline, and also for the BSD group at the end of 8 week Vitamin D 3 supplementation. Results: Baseline ACC GABA/creatine (Cr) was lower in BSD than in TD (F[1,31] = 8.91, p = 0.007). Following an 8 week Vitamin D 3 supplementation, in BSD patients, there was a significant decrease in YMRS scores (t = -3.66, p = 0.002, df = 15) and Children's Depression Rating Scale (CDRS) scores (t = -2.93, p = 0.01, df = 15); and a significant increase in ACC GABA (t = 3.18, p = 0.007, df = 14). Conclusions: Following an 8 week open label trial with Vitamin D 3 , BSD patients exhibited improvement in their mood symptoms in conjunction with their brain neurochemistry.

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Section: Limitations and Future Considerationssupporting

confidence: 54%

Vitamin D₃Supplemental Treatment for Mania in Youth with Bipolar Spectrum Disorders

Sikoglu

Navarro

Starr

et al. 2015

Journal of Child and Adolescent Psychopharmacology

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“…Atypical antipsychotics are as effective as typical antipsychotics and have reduced the incidence of extrapyramidal side effects, including akathisia, dystonia and tardive dyskinesia. 17,32 Of the atypical agents, two currently have an IM form available: olanzapine (Zyprexa®) and ziprasidone (Geodon®). Both are at least as effective as haloperidol at producing rapid tranquilization in acutely agitated patients.…”

Section: Discussionmentioning

confidence: 99%

“…Atypical antipsychotics may be associated with prolongation of the QT interval and sudden cardiac death, and appropriate precautions should be taken when administering the drug. 17,33 Although some trials have provided limited evidence for a superior speed of onset 34,35 or degree of response, 32,34,36 other studies have demonstrated similar results between first-generation and second-generation antipsychotics (SGA). 10,37 Moreover, other studies have not consistently demonstrated the superior efficacy of SGA compared to haloperidol alone.…”

Section: Discussionmentioning

confidence: 99%

Rapid tranquilization for agitated patients in emergency psychiatric rooms: a randomized trial of olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone

Baldaçara

Sanches

Cordeiro

et al. 2011

Rev. Bras. Psiquiatr.

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OBJECTIVE: To compare the effectiveness of intramuscular olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone as the first medication(s) used to treat patients with agitation and aggressive behavior. METHOD: One hundred fifty patients with agitation caused by psychotic or bipolar disorder were randomly assigned under double-blind conditions to receive olanzapine, ziprasidone, haloperidol plus midazolam, haloperidol plus promethazine or haloperidol alone. The Overt Agitation Severity Scale, Overt Aggression Scale and Ramsay Sedation Scale were applied within 12 hours after the first dosage. RESULTS: All medications produced a calming effect within one hour of administration, but only olanzapine and haloperidol reduced agitation by less than 10 points, and only olanzapine reduced aggression by less than four points in the first hour. After twelve hours, only patients treated with haloperidol plus midazolam had high levels of agitation and aggression and also more side effects. Ziprasidone, olanzapine and haloperidol alone had more stable results for agitation control, while ziprasidone, haloperidol plus promethazine and olanzapine had stable results for aggression control. CONCLUSION: Olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol were effective in controlling agitation and aggression caused by mental illness over 12 hours. Although all the drugs had advantages and disadvantages, haloperidol plus midazolam was associated with the worst results in all the observed parameters.

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“…Atypical neuroleptic drugs are currently widely used in treating dementia accompanied by neuropsychiatric symptoms in AD due to fewer adverse reactions compared with typical antipsychotics [Oliveira et al, ]. In addition, atypical neuroleptics have seen an increase in clinical use due to some documented evidence that they improve psychological and behavioral symptoms in AD [Lopez et al, ].…”

Section: Current State Of Intervention For Neuropsychiatric Symptoms mentioning

confidence: 99%

Psychotropic Drug Development Strategies that Target Neuropsychiatric Etiologies in Alzheimer's and Parkinson's Diseases

Schyf

2016

Drug Development Research

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Preclinical Research Neuropsychiatric symptoms are currently recognized as a common burden in patients suffering from Alzheimer's disease (AD), Parkinson's disease (PD), and many other neurodegenerative disorders. Earlier theories positing that these symptoms emerge predominantly in patients with late-stage disease have been largely dismissed. It is now generally accepted that many neuropsychiatric symptoms commonly manifest very early in neurodegenerative disease stages, and in many cases are even considered prodromal indicators. Despite intense research efforts, no reliable drug treatment strategies have been found for the neuropsychiatric symptoms associated with AD and PD. Among the medications commonly used at this stage, many present significant risks for patients in this particular cohort. Transcriptomic tools and proteomic profiling have clearly indicated that neurodegenerative diseases and their associated neuropsychiatric comorbidities are multifactorial in origin. As such, multiple-and in many cases divergent-disease etiologies lead to the neuropsychiatric symptoms associated with AD, PD, and other neurodegenerative disorders. The complexity of these pathways (initiated by a cascade of molecular events that involve several neurotransmitter systems) offer significant challenges to drug discovery efforts aimed at addressing these symptoms. In response to this complexity, a new paradigm has emerged that challenges the widely held assumption that "targeted" drug design is superior to the development of "multi-targeted" drugs as a strategy to address the neuropsychiatric symptoms associated with AD and PD. In this Overview, I offer an overview of drug discovery strategies and investigative drugs currently under development that address multiple CNS etiological targets associated with an array of neuropsychiatric symptoms. Drug Dev Res 77 : 458-468, 2016. © 2016 Wiley Periodicals, Inc.

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Review of the efficacy of placebo in comparative clinical trials between typical and atypical antipsychotics

Cited by 7 publications

References 33 publications

Vitamin D₃Supplemental Treatment for Mania in Youth with Bipolar Spectrum Disorders

Vitamin D₃Supplemental Treatment for Mania in Youth with Bipolar Spectrum Disorders

Rapid tranquilization for agitated patients in emergency psychiatric rooms: a randomized trial of olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone

Psychotropic Drug Development Strategies that Target Neuropsychiatric Etiologies in Alzheimer's and Parkinson's Diseases

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Review of the efficacy of placebo in comparative clinical trials between typical and atypical antipsychotics

Cited by 7 publications

References 33 publications

Vitamin D3Supplemental Treatment for Mania in Youth with Bipolar Spectrum Disorders

Vitamin D3Supplemental Treatment for Mania in Youth with Bipolar Spectrum Disorders

Rapid tranquilization for agitated patients in emergency psychiatric rooms: a randomized trial of olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone

Psychotropic Drug Development Strategies that Target Neuropsychiatric Etiologies in Alzheimer's and Parkinson's Diseases

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Product

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Vitamin D₃Supplemental Treatment for Mania in Youth with Bipolar Spectrum Disorders

Vitamin D₃Supplemental Treatment for Mania in Youth with Bipolar Spectrum Disorders