Pharmacopsychiatry最新文献

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Therapeutic Reference Range for Clozapine Plasma Levels in Parkinson's Disease or Dementia: A Systematic Review and Individual Participant Data Meta-analysis. 帕金森病或痴呆患者氯氮平血浆水平的治疗参考范围:一项系统综述和个体参与者数据荟萃分析
IF 2.2 3区 医学
Pharmacopsychiatry Pub Date : 2025-11-01 Epub Date: 2025-04-17 DOI: 10.1055/a-2560-4028
Nazar Kuzo, Marianna Piras, Ulrich C Lutz, Ekkehard Haen, Chin B Eap, Christoph Hiemke, Michael Paulzen, Georgios Schoretsanitis
{"title":"Therapeutic Reference Range for Clozapine Plasma Levels in Parkinson's Disease or Dementia: A Systematic Review and Individual Participant Data Meta-analysis.","authors":"Nazar Kuzo, Marianna Piras, Ulrich C Lutz, Ekkehard Haen, Chin B Eap, Christoph Hiemke, Michael Paulzen, Georgios Schoretsanitis","doi":"10.1055/a-2560-4028","DOIUrl":"10.1055/a-2560-4028","url":null,"abstract":"<p><p>Clozapine is a recommended treatment for psychotic symptoms in patients with Parkinson's disease (PD) and/or dementia. However, the therapeutic reference range for clozapine in these patients has not been established hitherto.The study was performed in three university hospitals in Germany and Switzerland, including clozapine-treated patients with PD and/or dementia. The primary outcome was tolerability based on reports of adverse drug reactions and/or changes in laboratory tests or electrocardiogram and/or clozapine discontinuation. We meta-analyzed demographic and pharmacokinetic parameters in patients tolerating clozapine well versus not. A meta-analytic summary receiver operating characteristic (SROC) to establish the clozapine upper level associated with poor tolerability was estimated.We analyzed a total of 99 patients suffering from PD (56.6%) and/or dementia (49.5%) with a mean age of 70.3±9.5 years and 41.4% females; poor tolerability was reported in 26 of 99 patients (26.3%). When comparing patients with and without poor tolerability, there were no differences in age, body mass index, sex, smoking, or clozapine dose, nor did we find statistically significant differences in clozapine levels (standardized mean difference 0.46, 95% confidence interval - 0.04 to 0.96, p=0.07), and heterogeneity was low (I<sup>2</sup>=0.0%). Clozapine blood levels above 193 ng/mL were associated with poor tolerability (SROC area-under-curve 0.6, sensitivity 39.7%, specificity 79.9%).One of four patients with PD and/or dementia treated with clozapine did not tolerate clozapine well, which was associated with a trend toward elevated clozapine concentrations. Monitoring drug levels may help to improve tolerability in these patients.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"263-271"},"PeriodicalIF":2.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144041990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of Physical Activity and Bone Mineral Density in Adults with Depressive Symptoms. 成人抑郁症状中体力活动与骨密度的关系
IF 2.2 3区 医学
Pharmacopsychiatry Pub Date : 2025-09-01 Epub Date: 2025-07-23 DOI: 10.1055/a-2645-4309
Shakila Meshkat, Qiaowei Lin, Vanessa K Tassone, Reinhard Janssen-Aguilar, Wendy Lou, Venkat Bhat
{"title":"Association of Physical Activity and Bone Mineral Density in Adults with Depressive Symptoms.","authors":"Shakila Meshkat, Qiaowei Lin, Vanessa K Tassone, Reinhard Janssen-Aguilar, Wendy Lou, Venkat Bhat","doi":"10.1055/a-2645-4309","DOIUrl":"10.1055/a-2645-4309","url":null,"abstract":"<p><p>Depression affects a significant proportion of adults in the United States. Studies exploring the association between depression and bone mineral density (BMD) have shown mixed results. Moreover, the relationship between BMD and physical activity (PA) in individuals with depressive symptoms is unknown. In this paper, we evaluated the association of depressive symptoms and PA with BMD, as well as difference in BMD among females with depressive symptoms before and after menopause.Data from the 2011-2018 National Health and Nutrition Examination Survey were used. Multivariable linear regression was used to explore the relationship between BMD and exposure variables.The study included 9,238 participants, of whom 766 had depressive symptoms. The presence and severity of depressive symptoms were significantly associated with lower BMD (aCoef.=-0.0200 for depressive symptoms, -0.0017 for depressive symptom severity; <i>p</i><0.001). Vigorous PA intensity was positively correlated with BMD, with and without controlling for depressive symptoms (aCoef.=0.0006; CI=[0.0003, 0.0008]; <i>p</i><0.001). Additionally, high levels of vigorous PA showed a significant positive relationship with BMD (aCoef.=0.0141; CI=[0.0078, 0.0205]; <i>p</i><0.001). Postmenopausal status was significantly associated with lower BMD. No significant interaction effects were observed between depressive symptoms and PA or menopausal status on BMD.Our study demonstrated the an association between depressive symptoms and low BMD, as well as a positive association between high-intensity vigorous PA and BMD. Future studies should aim to replicate our findings and evaluate the underlying mechanisms.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"226-234"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144699218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rapid Antidepressant and Antisuicidal Effects of Low-Dose Ketamine Infusion in Patients With Treatment-Resistant Depression With or Without Low-Grade Inflammation. 低剂量氯胺酮输注对伴或不伴低度炎症的难治性抑郁症患者的快速抗抑郁和抗自杀作用
IF 2.2 3区 医学
Pharmacopsychiatry Pub Date : 2025-09-01 Epub Date: 2024-12-20 DOI: 10.1055/a-2499-7207
Mu-Hong Chen, Tung-Ping Su, Wei-Chen Lin, Cheng-Ta Li, Hui-Ju Wu, Shih-Jen Tsai, Ya-Mei Bai, Wei-Chung Mao, Pei-Chi Tu
{"title":"Rapid Antidepressant and Antisuicidal Effects of Low-Dose Ketamine Infusion in Patients With Treatment-Resistant Depression With or Without Low-Grade Inflammation.","authors":"Mu-Hong Chen, Tung-Ping Su, Wei-Chen Lin, Cheng-Ta Li, Hui-Ju Wu, Shih-Jen Tsai, Ya-Mei Bai, Wei-Chung Mao, Pei-Chi Tu","doi":"10.1055/a-2499-7207","DOIUrl":"10.1055/a-2499-7207","url":null,"abstract":"<p><p>Low-grade inflammation (LGI) contributes to resistance against traditional antidepressants. However, whether the antidepressant and antisuicidal effects of ketamine on patients with treatment-resistant depression (TRD) differ between those with LGI and those without LGI remains unknown.This study included 167 patients with TRD, among whom 46 had LGI and 121 did not have LGI. The patients received a single infusion of either low-dose ketamine or a placebo. A C-reactive protein level of≥3 mg/L indicated LGI. Depressive symptoms were measured from baseline to day 3 by using the 17-item Hamilton Depression Rating Scale (HDRS) and the Montgomery-Asberg Depression Rating Scale (MADRS).Generalized estimating equation models revealed antidepressant effect of ketamine in patients with no LGI (HDRS scores: <i>p</i><0.001; MADRS scores: <i>p</i><0.001) but not in patients with LGI (all <i>p</i>>0.05). The antisuicidal effect of ketamine (indicated by the score on item 10 of the MADRS) was observed in both groups of patients with (<i>p</i>=0.046) and without LGI (<i>p</i><0.001). However, ketamine was effective for TRD regardless of whether inflammation levels were high or low, while the placebo response was notably greater only in patients with LGI.This study suggests that among patients with TRD, only those without LGI respond to low-dose ketamine infusion. Whether the negative findings of the antidepressant effect of ketamine among patients with LGI may be because of the effect of the placebo infusion needs further investigation. Further randomized, placebo-controlled studies are needed to validate these findings.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"235-241"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Influence of Glutamate Neurotransmission Genes on the Outcomes of Antipsychotic Treatments. 谷氨酸神经传递基因对抗精神病药物疗效的影响。
IF 2.2 3区 医学
Pharmacopsychiatry Pub Date : 2025-09-01 Epub Date: 2025-06-17 DOI: 10.1055/a-2603-0871
Marc Cendrós, Rosa Catalán, Mercè Torra, Rafael Penadés, Alexandre González-Rodríguez, Mercè Brunet, Josefina Perez-Blanco, Natalia Cullell, Alexandre Serra-Llovich, Marta H Hernandez, María J Arranz
{"title":"Influence of Glutamate Neurotransmission Genes on the Outcomes of Antipsychotic Treatments.","authors":"Marc Cendrós, Rosa Catalán, Mercè Torra, Rafael Penadés, Alexandre González-Rodríguez, Mercè Brunet, Josefina Perez-Blanco, Natalia Cullell, Alexandre Serra-Llovich, Marta H Hernandez, María J Arranz","doi":"10.1055/a-2603-0871","DOIUrl":"10.1055/a-2603-0871","url":null,"abstract":"<p><p>Traditionally, the aetiology of schizophrenia has been attributed to dopaminergic neurotransmission, but more recent information points to the role of glutamate pathways. Glutamatergic involvement in schizophrenia might be extensible to drug response. The aim of the study was to explore whether the variation in glutamate receptors, transporters and metabolism can influence the outcome of drug treatments.A total of 45 polymorphisms in the genes GRIN1, GRIN2A, GRIN2B, GRIN3A, GRIA1, GRIK2, GRM2, GRM3, GRM5, GRM8, SLC1A1, SLC1A3 and GAD1 were genotyped in 258 patients with schizophrenia. Efficacy and side effects were evaluated with the Positive and Negative Symptoms Scale and the UKU scale, respectively, at baseline and after 12 weeks.The analysis revealed associations between outcomes, including response and adverse effects and genetic variants in several genes (GAD1, GRIA1, GRIN2A, GRIN3A, GRIK2, GRM2, GRM5, GRM8 and SLC1A3). An association of rs1864205 in GRIA1 with autonomic side effects bordered statistical significance after correction for multiple comparisons.Our results suggest that genetic variation in glutamatergic pathways can influence the efficacy and safety of antipsychotic drugs.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"205-215"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12404797/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144317580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exposure to Psychotropic Drugs and Colorectal Cancer Risk in Patients with Affective Disorder: A Nested Case-Control Study. 情感性障碍患者的精神药物暴露与结直肠癌风险:一项巢式病例-对照研究。
IF 2.2 3区 医学
Pharmacopsychiatry Pub Date : 2025-09-01 Epub Date: 2024-12-17 DOI: 10.1055/a-2479-9430
Tien-Wei Hsu, Shih-Jen Tsai, Tzeng-Ji Chen, Mu-Hong Chen, Chih-Sung Liang
{"title":"Exposure to Psychotropic Drugs and Colorectal Cancer Risk in Patients with Affective Disorder: A Nested Case-Control Study.","authors":"Tien-Wei Hsu, Shih-Jen Tsai, Tzeng-Ji Chen, Mu-Hong Chen, Chih-Sung Liang","doi":"10.1055/a-2479-9430","DOIUrl":"10.1055/a-2479-9430","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to assess the association between the risk of colorectal cancer (CRC) and exposure to mood stabilizers, antidepressants, and antipsychotics in patients with affective disorders.</p><p><strong>Methods: </strong>This nested case-control study used data from the National Health Insurance Database of Taiwan collected between 2001 and 2011. All participants in this study had affective disorders. Then, 1209 patients with CRC and 1:10 matched controls were identified based on their demographic and clinical characteristics. A logistic regression model adjusted for demographic and clinical characteristics was used to determine the risk of developing CRC after exposure to psychotropic drugs.</p><p><strong>Results: </strong>Among patients with affective disorders, exposure to mood stabilizers (reported as odds ratio; 95% confidence interval; 0.75; 0.57-0.98), antidepressants (0.83; 0.70-0.97), second-generation antipsychotics (0.67; 0.52-0.86), and first-generation antipsychotics (0.65; 0.52-0.81) were associated with a reduced risk of CRC compared to patients who were not exposed. When considering specific drugs, carbamazepine (0.34; 0.12-0.95), valproic acid (0.66; 0.46-0.95), gabapentin (0.44; 0.20-0.99), fluoxetine (0.82; 0.68-0.99), paroxetine (0.63; 0.45-0.87), and venlafaxine (0.72; 0.55-0.95) were associated with a lower risk of CRC.</p><p><strong>Conclusion: </strong>Exposure to psychotropic drugs in patients with affective disorders is associated with a lower risk of CRC compared to those who were not exposed. Although the causal relationship between psychotropic drug exposure and reduced risk of CRC could not be inferred directly, these findings may help clinicians and patients in clinical decision-making.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"216-225"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142847321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Are Intravenous Subnarcotic Ketamine Infusions as an Adjunct Treatment for Treatment-Resistant Depression Ready to be Recommended in European Guidelines? 静脉注射亚麻醉氯胺酮作为难治性抑郁症的辅助治疗准备在欧洲指南中推荐吗?
IF 2.2 3区 医学
Pharmacopsychiatry Pub Date : 2025-09-01 Epub Date: 2025-08-06 DOI: 10.1055/a-2646-7702
Udo Bonnet, Norbert Scherbaum, Georg Juckel, Tom Bschor
{"title":"Are Intravenous Subnarcotic Ketamine Infusions as an Adjunct Treatment for Treatment-Resistant Depression Ready to be Recommended in European Guidelines?","authors":"Udo Bonnet, Norbert Scherbaum, Georg Juckel, Tom Bschor","doi":"10.1055/a-2646-7702","DOIUrl":"10.1055/a-2646-7702","url":null,"abstract":"","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"242-244"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144795025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2001-2021 Comparative Persistence of Oral Antipsychotics in Patients Initiating Treatment: Superiority of Clozapine in Time-to-Treatment Discontinuation. 2001-2021 比较口服抗精神病药物在开始治疗患者中的持续性:氯氮平在停药时间上的优势。
IF 3.6 3区 医学
Pharmacopsychiatry Pub Date : 2025-07-01 Epub Date: 2024-11-11 DOI: 10.1055/a-2437-4366
Alberto Parabiaghi, Alessia A Galbussera, Barbara D'Avanzo, Mauro Tettamanti, Ida Fortino, Angelo Barbato
{"title":"2001-2021 Comparative Persistence of Oral Antipsychotics in Patients Initiating Treatment: Superiority of Clozapine in Time-to-Treatment Discontinuation.","authors":"Alberto Parabiaghi, Alessia A Galbussera, Barbara D'Avanzo, Mauro Tettamanti, Ida Fortino, Angelo Barbato","doi":"10.1055/a-2437-4366","DOIUrl":"10.1055/a-2437-4366","url":null,"abstract":"<p><strong>Background: </strong>Continuous antipsychotic (AP) therapy is crucial for managing psychotic disorders, and its early interruption reflects the drug's failure. Real-world epidemiological research is essential for confirming experimental data and generating new research hypotheses.</p><p><strong>Methods: </strong>The persistence of oral APs in a large population sample from 2000 to 2021 was analyzed by comparing AP prescriptions over this period across four Italian provinces, using dispensing data linked via a record-linkage procedure among regional healthcare utilization databases. We calculated personalized daily dosages and assessed time-to-treatment discontinuation over a 3-month period for patients initiating AP treatment. Treatment persistence was evaluated using Kaplan-Meier curves and Cox regression, with adjustments for age and sex.</p><p><strong>Results: </strong>Second-generation antipsychotics (SGAs) were favored over first-generation antipsychotics (FGAs), with olanzapine as the most prescribed. Within the study time frame, 42,434 individuals were prescribed a new continuous AP regimen. The analysis revealed 24 significant differences within 28 comparisons. As a class, SGAs demonstrated better treatment persistence than FGAs (HR: 0.76; 95%CI: 0.73, 0.79). Clozapine stood out for its superior persistence, surpassing all other SGAs, notably olanzapine (HR: 0.85; 95%CI: 0.79-0.91) and risperidone (HR: 0.80; 95%CI: 0.74-0.87). Olanzapine and aripiprazole showed better results than both risperidone and quetiapine. Quetiapine showed inferior 3-month persistence in all pairwise comparisons.</p><p><strong>Conclusion: </strong>The study results provide insight into the performance dynamics among SGAs: clozapine, despite being one of the less frequently dispensed APs in our sample, emerged as a significant prescription choice. The significance of pharmacoepidemiological studies in complementing experimental findings is also underscored.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"159-169"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142625734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Instruments Assessing Medication Literacy in Psychiatric Patients and the Caregivers: A Systematic Review. 评估精神科病人及照护者药物素养的仪器:一项系统回顾。
IF 3.6 3区 医学
Pharmacopsychiatry Pub Date : 2025-07-01 Epub Date: 2025-06-04 DOI: 10.1055/a-2591-2089
Wan F H Wan Mohd Johari, Dayang F Abang Ma'mon, Izyan A Wahab, Nurul A Bahruddin, Noorasyikin Shamsuddin
{"title":"Instruments Assessing Medication Literacy in Psychiatric Patients and the Caregivers: A Systematic Review.","authors":"Wan F H Wan Mohd Johari, Dayang F Abang Ma'mon, Izyan A Wahab, Nurul A Bahruddin, Noorasyikin Shamsuddin","doi":"10.1055/a-2591-2089","DOIUrl":"10.1055/a-2591-2089","url":null,"abstract":"<p><p>This systematic review investigates the instruments measuring medication literacy (ML) in psychiatric patients and their caregivers. Despite the critical role of ML in ensuring adherence to medication regimens, especially in populations with mental health conditions, existing instruments lack comprehensive validation of their measurement properties. This review identifies and assesses four instruments designed for psychiatric populations based on COSMIN guidelines. The findings reveal significant gaps in the validity and reliability of these tools. The review underscores the necessity for developing new, robust ML instruments tailored to people with mental illnesses and their caregivers to enhance clinical practice and patient outcomes. The results help to inform future psychiatry research and its clinical applications, promoting better medication management and improving adherence towards overall management in psychiatric care settings.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"178-186"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144226155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regulatory Alignment of Psilocybin Clinical Trials in Major Depressive Disorder on ClinicalTrials.gov: A Cross-Sectional Analysis. 在ClinicalTrials.gov网站上,裸盖菇素治疗重度抑郁症临床试验的调控一致性:一项横断面分析。
IF 3.6 3区 医学
Pharmacopsychiatry Pub Date : 2025-07-01 Epub Date: 2025-04-17 DOI: 10.1055/a-2529-7029
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc, Zuzanna Gaca, Lukasz Szarpak, Wiesław J Cubała
{"title":"Regulatory Alignment of Psilocybin Clinical Trials in Major Depressive Disorder on ClinicalTrials.gov: A Cross-Sectional Analysis.","authors":"Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc, Zuzanna Gaca, Lukasz Szarpak, Wiesław J Cubała","doi":"10.1055/a-2529-7029","DOIUrl":"10.1055/a-2529-7029","url":null,"abstract":"<p><p>Regulatory compliance is crucial in the clinical development of psychedelic substances, including psilocybin. This study aimed to examine the alignment of clinical trial protocols for psilocybin in the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD) with established regulatory requirements.A cross-sectional investigation was conducted on ClinicalTrials.gov using the keywords: \"Psilocybin\" and \"Psilocin\" to identify interventional studies with posted trial protocols. Only protocols for MDD and TRD were included. Data extraction focused on key regulatory aspects, including safety, functional unblinding, expectancy bias, and the distribution of investigational medical products.Eleven psilocybin trial protocols were identified, with four meeting the inclusion criteria. The most commonly studied psilocybin dose was 25 mg. Two trials were double-blind. Although the analyzed protocols superficially adhered to regulatory requirements, there were gaps in addressing potential drug interactions, the acute and chronic concurrent use of antidepressants, and prohibited medications. Certain aspects, such as functional unblinding or expectancy bias, did not share all pathways. Risk mitigation strategies were primarily based on external criteria. Patients with bipolar spectrum disorders or schizoaffective disorders were excluded.This study underscores the importance of conducting clinical trials on psychedelics in strict adherence to regulatory standards. Future research should focus on improving regulatory compliance and exploring the efficacy of psychedelics in broader patient populations.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"187-197"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Challenges Related to the Implementation of Measurement-Based Care for the Treatment of Major Depressive Disorder: A Feasibility Study. 实施以测量为基础的护理治疗重度抑郁症的挑战:可行性研究
IF 3.6 3区 医学
Pharmacopsychiatry Pub Date : 2025-07-01 Epub Date: 2025-02-25 DOI: 10.1055/a-2508-5757
Emytis Tavakoli, Angela Xiang, Mohamed I Husain, Daniel M Blumberger, Stefan Kloiber, Daniel J Mueller, Abigail Ortiz, Athina Perivolaris, Benoit H Mulsant
{"title":"Challenges Related to the Implementation of Measurement-Based Care for the Treatment of Major Depressive Disorder: A Feasibility Study.","authors":"Emytis Tavakoli, Angela Xiang, Mohamed I Husain, Daniel M Blumberger, Stefan Kloiber, Daniel J Mueller, Abigail Ortiz, Athina Perivolaris, Benoit H Mulsant","doi":"10.1055/a-2508-5757","DOIUrl":"10.1055/a-2508-5757","url":null,"abstract":"<p><p>Measurement-based care (MBC) involves systematically assessing patients' symptoms and adverse events using standardized scales to guide treatment. While MBC has been shown to enhance the quality of care and outcomes in the pharmacotherapy of major depressive disorder (MDD), it is still rarely used in clinical practice. In this study, the feasibility of implementing MBC was assessed for patients with MDD seen in a large outpatient psychiatry clinic.Adults diagnosed with MDD were assessed at baseline and during a 12-week follow-up by phone or via emailed links with: the 9-item Patient Health Questionnaire (PHQ-9), an adverse effect rating scale, and a published suicide risk management protocol (SRMP). Antidepressants were recommended based on preferences expressed by the participant and treating psychiatrist; dosages were adjusted by the treating psychiatrist based on symptomatic improvement and adverse events.Over 2 years, 52 (21.2%) of 246 patients referred to the study were enrolled, 28 (53.8%) completed all assessments at all follow-up visits, 45 (87.0%) participants were prescribed one of the recommended antidepressants, and 22 (42.3%) remitted. Of the 27 participants presenting with suicidal ideation, 18 (66.6%) experienced a full resolution of these ideations.These findings highlight the challenges in implementing MBC for the pharmacotherapy of MDD and confirm some barriers to its broad adoption in clinical practice. The study also highlights its benefits in the selected group of patients who engage in MBC. Future studies need to continue to explore innovative ways to facilitate its broader implementation.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"170-177"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143503135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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