The purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment.
The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises.
To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites.
At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed.
Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system.
In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually.
2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.

开始日期2015-01-01

申办/合作机构

Hannover Medical School

NCT01450514 / Completed临床2期

POC Study of Pipamperone 15mg Added to Stable Risperidone or Paliperidone Treatment in Chronic Schizophrenic and Schizoaffective Patients With Residual Symptoms: a Phase I/IIa, Randomized, Double-blind, Placebo-controlled Trial of 7 Weeks

This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and clinical outcome of chronic schizophrenic patients with residual, so-called 'positive' symptoms, as well as on cognition, motivation, subjective well-being of patients, negative symptoms, general psychopathological symptoms and safety/tolerability.

开始日期2012-03-01

申办/合作机构

PharmaNeuroBoost NV

100 项与盐酸匹泮哌隆相关的临床结果

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100 项与盐酸匹泮哌隆相关的转化医学

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100 项与盐酸匹泮哌隆相关的专利（医药）

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162

项与盐酸匹泮哌隆相关的文献（医药）

2023-01-01·Frontiers in psychiatry

Dose-dependent QTc interval prolongation under haloperidol and pipamperone in the management of delirium in a naturalistic setting.

Article

作者: Bohny, Philipp ; Jenewein, Josef ; Boettger, Soenke

Objective:

Delirium is an acute, life-threatening neuropsychiatric disorder frequently occurring among hospitalized patients. Antipsychotic medications are often recommended for delirium management but are associated with cardiovascular risks. This study aimed to investigate the frequency and magnitude of QTc interval prolongation and clinically relevant side effects occurring in delirium patients managed with haloperidol and/or pipamperone.

Methods:

This descriptive retrospective cohort study evaluated 102 elderly (mean age: 73.2 years) inpatients with delirium treated with either haloperidol, pipamperone, a combination of both, or neither in a naturalistic setting over the course of up to 20 days or until the end of delirium.

Results:

A total of 86.3% of patients were treated with haloperidol and/or pipamperone at a mean daily haloperidol-equipotent dose of 1.2 ± 1 mg. Non-cardiovascular side effects were registered in 2.9% of all patients and correlated with higher scores on the Delirium Observation Screening Scale. They did not occur more frequently under antipsychotic treatment. The frequency of QTc interval prolongation was comparably common among all groups, but prolongation magnitude was higher under antipsychotic treatment. It was positively correlated with antipsychotic dosage and the total number of QTc interval-prolonging substances administered. Critical QTc interval prolongation was registered in 21.6% (n = 19) of patients in the group treated with antipsychotics compared to 14.3% (n = 2) of patients in the unmedicated group; however, the difference was not statistically significant. Polypharmacy was associated with a higher risk of critical QTc interval prolongation and increased mortality during delirium.

Conclusion:

Delirium treatment with haloperidol and/or pipamperone was not associated with a higher risk of QTc-interval prolongation in this naturalistic patient sample but was greater in magnitude and correlated with equipotent dosage and the number of QT interval-prolonging substances used. Polypharmacy was associated with higher mortality and increased risk of critical QTc prolongation.

2023-01-01·Frontiers in psychiatry

Determinants of severe QT_c prolongation in a real-world gerontopsychiatric setting.

Article

作者: Jahn, Kirsten ; Wedegärtner, Felix ; Bleich, Stefan ; Krause, Olaf ; Heck, Johannes ; Krüger, Tillmann H C ; Kahl, Kai G ; Schröder, Sebastian ; Schulze Westhoff, Martin ; Pfister, Tabea ; Groh, Adrian

Introduction:

QT_c prolongation carries the risk of ventricular tachyarrhythmia (Torsades de Pointes) and sudden cardiac death. Psychotropic drugs can affect ventricular repolarization and thus prolong the QT_c interval. The present study sought to investigate the risk factors (pharmacological and non-pharmacological) of severe QT_c prolongation in gerontopsychiatric patients.

Methods:

Electrocardiograms of patients on a gerontopsychiatric ward were screened for QT_c prolongation. Medication lists were examined utilizing the AzCERT classification. Potential drug interactions were identified with the electronic drug interaction program mediQ.

Results:

The overall prevalence of QT_c prolongation was 13.6%, with 1.9% displaying severe QT_c prolongation (≥ 500 ms). No statistically significant differences between patients with moderate and severe QT_c prolongation were identified; however, patients with severe QT_c prolongation tended to take more drugs (p = 0.063). 92.7% of patients with QT_c prolongation took at least one AzCERT-listed drug, most frequently risperidone and pantoprazole. Risperidone and pantoprazole, along with pipamperone, were also most frequently involved in potential drug interactions. All patients displayed additional risk factors for QT_c prolongation, particularly cardiac diseases.

Conclusion:

In addition to the use of potentially QT_c-prolonging drugs, other risk factors, especially cardiac diseases, appear to be relevant for the development of QT_c prolongation in gerontopsychiatric patients. Pantoprazole was frequently involved in potential drug interactions and should generally not be used for more than 8 weeks in geriatric populations. As clinical consequences of QT_c prolongation were rare, potentially QT_c-prolonging drugs should not be used overcautiously; their therapeutic benefit should be considered as well. It is paramount to perform diligent benefit-risk analyses prior to the initiation of potentially QT_c-prolonging drugs and to closely monitor their clinical (side) effects.

2022-03-01·Human psychopharmacology4区 · 医学

Characteristics of antipsychotic drug‐induced hypothermia in psychogeriatric inpatients

4区 · 医学

Article

作者: Bouanane, Annabelle ; Lange‐Asschenfeldt, Christian ; Supprian, Tillmann ; Kojda, Georg ; Paschali, Myrella ; Meisenzahl‐Lechner, Eva ; Christl, Julia ; Kamp, Daniel

Abstract:

Objective:

Hypothermia is a potentially lethal adverse reaction to typical and atypical antipsychotic drugs (APD). Among predisposing factors are advanced age and comorbid somatic diseases. The aim of this study was to assess the incidence of hypothermia and quantify risk factors.

Method:

Charts of N = 3002 psychogeriatric inpatients were screened for incidence of hypothermia (body core temperature <35.0°C). The frequency of hypothermia was compared between patients treated with versus without APD and, within the sample of APD‐treated patients, for (1) specific APD, (2) sex, (3) main diagnosis, and (4) age.

Results:

N = 54 cases (2.6%) of hypothermia occurred in APD‐treated patients and 12 cases (1.3%) in non‐APD‐treated patients (p = 0.024). In APD‐treated patients, only male sex (p = 0.038) and pipamperone were associated with a higher incidence of hypothermia (p = 0.0017). Whereas the main diagnosis delirium showed a trend to significance, age did not correlate with hypothermia.

Conclusion:

Medication with pipamperone was associated with an increased risk of hypothermia. The advanced age of our sample might as well explain the high incidence of hypothermia within our sample and the failure to detect high age as a risk factor due to a ceiling effect.

项与盐酸匹泮哌隆相关的新闻（医药）

2024-02-01

·GlobeNewswire-Health Care

ANeuroTech publishes Phase IIIa data for ANT-01, an adjunctive anti-depression drug, in Personalized Medicine in Psychiatry

ANT-01 is in late-stage development as an adjunctive treatment for major depressive disorder (MDD), with minimal side effects Published data demonstrates substantially better safety profile of ANT-01 than previous serotonin and dopamine antagonists for the treatment of MDD ANeuroTech also files patent application for long-acting prodrugs 31 January 2024: ANeuroTech, a leader in the development of innovative mental health treatments with minimal or no side effects, today announced the publication of Phase IIIa data for ANT-01, its adjunctive anti-depression drug, in the journal of Personalized Medicine in Psychiatry. The Company also filed a Composition of Matter (CoM) patent for the long-acting effects of ANT-01. The Phase IIIa data, published in a paper titled: Low dose pipamperone therapy for major depression: A randomized controlled clinical trial comparison with citalopram, demonstrates that ANT-01 has a substantially better safety profile than previous serotonin and dopamine antagonists used to treat MDD, and that low dose pipamperone has the potential to be an efficacious treatment for MDD as either a monotherapy or in combination with currently available anti-depressants. The paper was co-authored by Erik Buntinx, Lars Bastiaanse, Alan S Schatzberg, Charles B Nemeroff and Philip D Harvey. ANT-01 is a highly selective dopamine and serotonin receptor antagonist and a low dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic developed and marketed at a high dose range for the treatment of psychotic disorders. ANT-01 has been shown to improve cognitive function and anhedonia, something which has not been demonstrated by any other adjunctive antidepressant molecule, with data demonstrating it is more efficient, with an improved safety profile, when compared with currently available adjunctive therapies. ANeuroTech is also developing prodrugs of ANT-01 as a long-acting treatment for MDD. Long-acting treatments remove the need for daily medication, resulting in better patient adherence and a better patient experience. There is currently no long-acting anti-depressant drug available. Dr Erik Buntinx, CEO and Founder of ANeuroTech, commented: “As a psychiatrist, I have seen too often the non-response and problems that come with adjunctive anti-depressant drugs, including a lack of an effective impact on cognitive dysfunctioning and on the loss of the ability to feel pleasure, two key domains in almost all MDD patients with an inadequate response on their initial antidepressant. At ANeuroTech, we are working to bring effective treatments, with minimal or no side-effects, to patients who suffer with depression. The publication in Personalized Medicine in Psychiatry and our patent filing for a long-acting drug are two important milestones in our efforts to meet our goal of finding better ways to help people with MDD.” ANeuroTech, based in Alken, Belgium, is a leader in the development of innovative mental health treatments with minimal or no side effects. The company is in late-stage clinical development of its lead asset, ANT-01, an adjunctive anti-depression drug which has been shown in late-stage clinical trials to improve depression and have a positive impact on cognitive function and anhedonia, with an excellent safety profile. ANT-01 is a low-dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic discovered by the late Dr Paul Janssen and marketed in Europe for the treatment of psychotic disorders. ANeuroTech plans to begin a pivotal Phase IIIb clinical trial of ANT-01 as an adjunctive anti-depression drug for major depressive disorder (MDD) in 2024. ANeuroTech was founded by CEO, Dr Erik Buntinx, an experienced clinician, key opinion leader and global coordinating principal investigator on clinical trials for a number of CNS drugs including Spravato (esketamine). Many of the ANeuroTech team were previously at Johnson & Johnson where they gained extensive experience in the development of treatments for mental and other health disorders. For more information, please visit: https://www.aneurotech.com/ The content above comes from the network. if any infringement, please contact us to modify.

临床3期临床2期

100 项与盐酸匹泮哌隆相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01482	盐酸匹泮哌隆	N05AD05	DB09286

研发状态

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适应症	国家/地区	公司	日期
精神分裂症	日本	Sannova KK	1966-06-21
精神分裂症	日本	Alfresa Pharma Corp.	1966-06-21

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00672659 (Pubmed \| Psychol Med)	临床2期	重度抑郁症	165	Citalopram 40 mg + Pipamperone 5 mg	壓艱範艱網蓋繭製艱簾(糧獵廠網衊遞夢繭遞淵) = 製鹽壓衊艱築觸淵簾醖範積膚範廠觸膚鹹廠網 (構簾觸製鑰獵願顧築醖 )	积极	2011-10-01
NCT00672659 (Pubmed \| Psychol Med)	临床2期	重度抑郁症	165	Citalopram + Placebo	壓艱範艱網蓋繭製艱簾(糧獵廠網衊遞夢繭遞淵) = 鑰網鬱鬱鏇積構願遞鬱範積膚範廠觸膚鹹廠網 (構簾觸製鑰獵願顧築醖 )	积极	2011-10-01
SFN2000	N/A	-	-	pipamperone (Dopamine D4.2 receptor)	襯窪餘範醖獵築襯範顧(繭齋網積憲壓鹽餘簾膚) = 膚齋蓋艱鹽顧鬱製網齋淵鹽夢夢繭鬱積構繭艱 (網選繭願遞憲願繭鬱廠 )	-	2000-11-07