The efficacy of pipamperone and aripiprazole on behaviors that challenge in people with intellectual disabilities: A series of N-of-1 cross-over trials

Start Date01 Jan 2026

Sponsor / Collaborator

Stichting GGZ Drenthe

EUCTR2016-002859-19-NL

/ RecruitingPhase 3IIT

Withdrawing off-label antipsychotics in people with intellectual disabilities: why does it fail?

Start Date20 Sep 2016

Sponsor / Collaborator

Erasmus MC

EUCTR2016-001554-18-DE

/ TerminatedPhase 4IIT

English: Are Antipsychotics Neurotoxic or Neuroprotective? A Randomised Multicentre Longitudinal Study for Comparison of Two Therapy Strategies for the Treatment of Schizophrenia.

Start Date31 Aug 2016

Sponsor / Collaborator

RWTH Aachen University

100 Clinical Results associated with Pipamperone Hydrochloride

100 Translational Medicine associated with Pipamperone Hydrochloride

100 Patents (Medical) associated with Pipamperone Hydrochloride

362

Literatures (Medical) associated with Pipamperone Hydrochloride

01 Apr 2026·FORENSIC SCIENCE INTERNATIONAL

Development of a standardized routine workflow for entomological and toxicological analysis using larvae of two forensically relevant fly species (Diptera, Calliphoridae)

Article

Author: Wissenbach, Dirk K ; Siemon, Laura ; Niederegger, Senta

For more than four decades, no standardized study design or workflow has been established for systematic entomotoxicological research in forensic casework. This study aimed to develop a universal rearing protocol for fly larvae grown on drug-spiked tissue surrogate and a standardized workflow for the qualitative analysis of pharmacologically active compounds (PACs) in insects of different developmental stages. Larvae of Protophormia terraenovae and Lucilia sericata were reared on minced meat serving as tissue surrogate. First-instar larvae were transferred to minced meat spiked with diazepam, amitriptyline, pipamperone, or lamotrigine, each triturated with placebo tablets. Actively feeding and post-feeding third-instar larvae were soaked for 24 h in ethanol (30 mL, 70:30, v:v), and both the larvae and the soaking solution were analysed using LC-MS/MS. The larval extraction method was optimized by replacing pure acetonitrile with an acetonitrile-methanol mixture and introducing centrifugation at -10°C. PAC detection was achieved in both larvae and soaking solution, confirming the sensitivity and applicability of the method. The workflow was further validated using authentic postmortem case samples. These findings demonstrate that ethanol-soaked larvae can be used effectively for both toxicological and entomological analyses. Overall, this study provides a universal and standardized workflow that simplifies and strengthens the application of entomotoxicology in forensic casework.

01 Jan 2026·PSYCHIATRY RESEARCH

Trends in antipsychotic and antidepressant prescriptions among German adolescents: Data from the largest statutory health insurance in Germany

Article

Author: Tanaka, Luana F ; Selke, Gisbert W ; Eichler, Uwe ; Jäger, Simon ; Langner, Irene ; Hach, Isabel

BACKGROUND:

The prevalence of mental health disorders in adolescents, as well as the prescription of psychotropic drugs, especially antidepressants and antipsychotics, has increased in the last decades.

METHODS:

We analyzed changes in prescription prevalence (PP) and prescription volume (PV), measured as daily defined doses (DDD) per 1000/day of antidepressant and antipsychotic among adolescents aged 12 to 17 covered by the German statutory health insurer AOK from 2015 to 2023. We compared the percentage change between the fourth quarters of 2015 and 2023 and conducted a joinpoint analysis of PP and PV reporting quarterly percent changes (QPC).

RESULTS:

In 2023, the antidepressants citalopram, escitalopram, fluoxetine, and sertraline, and the antipsychotics aripiprazole, quetiapine, risperidone, and pipamperone were prescribed with a frequency > 100,000 DDD. Compared to 2015, the most substantial PP increases were seen for sertraline (girls: 482 %, boys: 344 %) and escitalopram (girls: 194 %, boys: 103 %). Concerning antipsychotics, while overall PP declined in boys (-9.7 %), driven primarily by reductions in risperidone, an overall rise in girls was detected (26 %) as a result of increases in aripiprazole (110 %) and quetiapine (59 %).

DISCUSSION:

Our results indicate an increase in pharmacotherapy for mental disorders in adolescents, especially among girls. The quantity and quality of changes in the prescription of psychotropic drugs are greater than would be expected based solely on the increase in diagnoses. This could indicate a change in prescribing behavior, in the sense of earlier drug intervention for mental disorders and/or more off-label prescriptions. This gives rise to concerns about the appropriateness of psychotropic prescriptions to this group of patients.

02 Nov 2025·CLINICAL TOXICOLOGY

QT interval prolongation in acute antipsychotic poisoning: systematic review and recommendations

Review

Author: Berling, Ingrid ; Wong, Anselm ; Ferrer Dufol, Ana Maria Alicia ; Mackenzie, Constance Alexa ; Yates, Christopher ; Hayes, Bryan D ; Isbister, Geoffrey K ; Hatten, Benjamin W ; Hoffman, Robert S ; Gosselin, Sophie ; Heyerdahl, Fridtjof ; Stanton, Matt ; Lonati, Davide ; Roberts, Darren M ; Hoegberg, Lotte C G ; Smith, Angela ; Othong, Rittirak ; Paasma, Raido

INTRODUCTION:

Antipsychotic medications are often associated with QT interval prolongation, which can lead to ventricular dysrhythmias, including torsade de pointes. However, unstable or significant dysrhythmic events are rare. Evidence-based recommendations on the assessment and management of poisoned patients at risk for QT interval prolongation are lacking. Current practice often involves costly and lengthy cardiac monitoring, leading to delayed disposition of the patient from emergency departments or prolonged monitoring times in other hospital units. To address this issue, the QT Interval Prolongation in Clinical Toxicology Workgroup was formed by the Clinical Toxicology Recommendations Collaborative to develop evidence-based recommendations for the management and treatment of QT interval prolongation in acute overdose patients. This article reports our findings on patients with antipsychotic poisoning.

METHODS:

A systematic review of the literature regarding QT interval prolongation in all acute overdoses was undertaken, and the evidence was summarized for antipsychotic medication overdose. Voting statements were drafted using a predetermined format for monitoring the QT interval and use of continuous cardiac monitoring. A two-round modified Delphi method was used to reach a consensus. The strength of consensus was measured using the disagreement index as defined by the RAND/UCLA Appropriateness Method.

RESULTS:

From the 327 articles that were included in the systematic review of QT interval prolongation in all acute overdoses, a total of 55 articles were relevant to antipsychotic medication-induced QT prolongation in acute overdose. Medications with more than three articles were reviewed individually for recommendations, whilst medications with less than three were grouped together for discussion as miscellaneous. Individual medication recommendations were made for amisulpride (15 articles), thioridazine (11 articles), ziprasidone (eight articles) and quetiapine (13 articles), whilst consensus statements based on limited data were made for acute ingestions of clozapine, haloperidol, iloperidone, pimozide, pipamperone, olanzapine and risperidone (14 articles in total). The electrocardiogram is suggested as a risk assessment tool for ingestion of all antipsychotic medication. We recommend continuous cardiac monitoring for patients ingesting more than amisulpride 2 g, thioridazine 1 g, and ziprasidone 3 g. We suggest continuous cardiac monitoring for the above-mentioned medications for lower dose ingestions as well as for ingestions of haloperidol, iloperidone, pimozide and pipamperone. We do not suggest continuous cardiac monitoring for acute clozapine and risperidone poisoning, and do not recommend continuous cardiac monitoring for the QT interval in acute olanzapine or quetiapine poisoning. The need for ongoing cardiac monitoring should be guided by an individual risk assessment considering the medication and dose ingested, the time since ingestion, as well as other factors such as heart rate or co-ingestions.

DISCUSSION:

The quality of evidence for the risk of QT interval prolongation and torsade de pointes is heterogeneous among different antipsychotics and inherently constrains the recommendations. Available data suggest that amisulpride, thioridazine and ziprasidone are associated with QT interval prolongation and torsade de pointes, while the risk is likely overstated for quetiapine, olanzapine and risperidone. Ongoing research is needed to improve management strategies for acute antipsychotic overdose-induced QT interval prolongation and dysrhythmias.

CONCLUSIONS:

The QT Interval Prolongation in Clinical Toxicology Workgroup recommends the use of screening electrocardiograms in all patients with acute antipsychotic medication overdose and cardiac monitoring in patients with at-risk overdoses from thioridazine, amisulpride, and ziprasidone. The QT Interval Prolongation in Clinical Toxicology Workgroup suggests the same approach for patients with overdoses of haloperidol, iloperidone, pipamperone and pimozide. The risk of torsade de pointes is likely overstated for acute antipsychotic medication overdose as a general class group, and concern should rather focus on a few specific medications.

News (Medical) associated with Pipamperone Hydrochloride

01 Feb 2024

·www.globenewswire.com

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.

Phase 3Phase 2

05 Jul 2022

·www.biospace.com

Seagen, Anebulo and ANeuroTech Start July with a Bang

Positive clinical data from pharmaceutical companies Seagen and Anebulo were announced Tuesday, along with an announcement of support from the U.S. Food and Drug Administration for ANeuroTech’s innovative new treatment for major depressive disorder (MDD). Seagen’s Touts Positive Phase II Data in Colorectal Cancer Seagen's open-label Phase II MOUNTAINEER trial has produced positive full results. The trial was designed to investigate the safety and efficacy of Tukysa (tucatinib) when administered alongside trastuzumab, in patients with HER2-positive metastatic colorectal cancer (mCRC). The published results represent follow-up data from 84 patients who received the dual treatment. The patients showed a median duration of response at 12.4 months, and a 38.1% confirmed objective response rate. The median progression-free survival duration observed was 8.2 months. “This study has shown the benefits of dual-HER2 inhibition with tucatinib and trastuzumab in patients with HER2-positive metastatic colorectal cancer, including many whose cancer had spread to the liver or lungs before joining the trial,” Roger Dansey, M.D., Seagen’s interim CEO and chief medical officer said. “We believe this chemotherapy-free combination may play an important role in addressing the unmet needs of patients with this disease.” Patients with mCRC currently have limited treatment options. Seagen intends to supplemental New Drug Application for Tukysa to bring a chemotherapy-free option to patients. ANeuroTech’s MDD Drug Receives Positive FDA Feedback ANeuroTech also kicked off July with a bang. The company's Phase IIIb development trial of ANT-01, a drug being developed for MDD, has received positive feedback from the FDA after a pre-investigational new drug (IND) application meeting. The trial will assess the safety and efficicay of ANT-01 combined with a first-line antidepressant versus placebo. Existing treatments for this disorder come with the possibility of a wide range of negative side effects but if ANT-01 reaches the commercial market, patients would have access to a treatment that has little to no side effects. The treatment is a reduced dose of pipamperone dihydrochloride, an antipsychotic that is typically prescribed at a high dose for patients with psychotic conditions. Notably, this trial stands out with a unique secondary endpoint that tracks a participant’s improvement or decline in feelings of pleasure and cognitive function. “ANT-01 has the potential to change the treatment paradigm for the ~190 million patients worldwide with MDD who are not currently helped by initial treatment with antidepressants,” Dr. Rudi Pauwels, executive chairman of ANeuroTech said. An IND application filing for ANT-01 is anticipated in late 2022, and ANeuroTech intends to apply for Fast-Track Designation for the treatment. Anebulo Drug Succeeds in Reversing Acute Cannabinoid Intoxication As the United States moves slowly toward loosening restrictions on the use of cannabinoids, clinical trials investigating potential toxicity levels become more imperative. Anebulo Pharmaceuticals, Inc. is one such company taking an interest in this topic. An ongoing Phase II study is evaluating whether ANEB-001, one of the company’s treatment candidates, might be the answer needed in the event that a patient intakes toxic levels of psychoactive cannabinoids that lead to a condition called acute cannabinoid intoxication (ACI). Positive topline results for this trial were published Tuesday, demonstrating tolerability and efficacy as the treatment reverses feelings of “highness” in patients and a successful primary endpoint measurement. After treatment with 50 mg of ANEB-001, 90% of the patients no longer felt high. After a higher dosage of 100 mg, 70% of patients no longer felt high. These ratios have increased significantly compared to the placebo group, in which only 25% of participants had resolved symptoms of ACI. Additional measurements evaluated central nervous system functions such as alertness and heart rate. The trial is double-blinded and randomized. “The number of individuals with cannabinoid-related intoxication visiting our emergency departments is clearly on the rise,” Dr. Andrew Monte M.D., Ph.D., professor of emergency medicine & medical toxicology at the University of Colorado’s Denver-Anschutz Medical Center said. “Patients are coming from multiple settings including first-time users taking small doses of THC, adults and children inadvertently ingesting powerful THC gummies, and regular users unintentionally overdosing on new and more powerful THC products. Introducing an effective cannabinoid antidote into our treatment options would represent a significant improvement in how we can manage these patients.”

05 Jul 2022

·www.biospace.com

Seagen, ANeuroTech Start July with a Clinical Bang

Scientist working in the laboratory sanjeri/Getty Images Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug. Positive clinical data from pharmaceutical companies Seagen and Anebulo were announced Tuesday, along with an announcement of support from the U.S. Food and Drug Administration for ANeuroTech’s innovative new treatment for major depressive disorder (MDD). Seagen’s Touts Positive Phase II Data in Colorectal Cancer Seagen’s open-label Phase II MOUNTAINEER trial has produced positive full results. The trial was designed to investigate the safety and efficacy of Tukysa (tucatinib) when administered alongside trastuzumab, in patients with HER2-positive metastatic colorectal cancer (mCRC). The published results represent follow-up data from 84 patients who received the dual treatment. The patients showed a median duration of response at 12.4 months, and a 38.1% confirmed objective response rate. The median progression-free survival duration observed was 8.2 months. “This study has shown the benefits of dual-HER2 inhibition with tucatinib and trastuzumab in patients with HER2-positive metastatic colorectal cancer, including many whose cancer had spread to the liver or lungs before joining the trial,” Roger Dansey, M.D., Seagen’s interim CEO and chief medical officer said. “We believe this chemotherapy-free combination may play an important role in addressing the unmet needs of patients with this disease.” Patients with mCRC currently have limited treatment options. Seagen intends to supplemental New Drug Application for Tukysa to bring a chemotherapy-free option to patients. ANeuroTech’s MDD Drug Receives Positive FDA Feedback ANeuroTech also kicked off July with a bang. The company’s Phase IIIb development trial of ANT-01, a drug being developed for MDD, has received positive feedback from the FDA after a pre-investigational new drug (IND) application meeting. The trial will assess the safety and efficicay of ANT-01 combined with a first-line antidepressant versus placebo. Existing treatments for this disorder come with the possibility of a wide range of negative side effects but if ANT-01 reaches the commercial market, patients would have access to a treatment that has little to no side effects. The treatment is a reduced dose of pipamperone dihydrochloride, an antipsychotic that is typically prescribed at a high dose for patients with psychotic conditions. Notably, this trial stands out with a unique secondary endpoint that tracks a participant’s improvement or decline in feelings of pleasure and cognitive function. “ANT-01 has the potential to change the treatment paradigm for the ~190 million patients worldwide with MDD who are not currently helped by initial treatment with antidepressants,” Dr. Rudi Pauwels, executive chairman of ANeuroTech said. An IND application filing for ANT-01 is anticipated in late 2022, and ANeuroTech intends to apply for Fast-Track Designation for the treatment.

Clinical ResultPhase 2Fast TrackPhase 3

100 Deals associated with Pipamperone Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D01482	Pipamperone Hydrochloride	N05AD05	DB09286

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Indication	Country/Location	Organization	Date
Schizophrenia	Japan	Alfresa Pharma Corp.	21 Jun 1966
Schizophrenia	Japan	Sannova KK	21 Jun 1966

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