Pharmacopsychiatry最新文献

{"title":"Correction: Electroconvulsive Therapy Versus Aripiprazole Addition to Clozapine in Patients with Clozapine-Resistant Symptoms (EMECLO): A Protocol of a Single-Blind, Multicenter, Randomized-Controlled Feasibility Trial.","authors":"Manouk den Toom, Laura Blanken, Inge Horn, Selene Veerman, Joris J B van der Vlugt-Molenaar, Mariken B de Koning, Jan Bogers, John Enterman, Martin de Jonge, Daniela Cianci, Gerardus W J Frederix, Hans J de Haas, Bram W Storosum, Mike Veereschild, Martin Javadzadeh, Peter F J Schulte, Dan Cohen, Jim van Os, Wiepke Cahn, Lieuwe de Haan, Jasper B Zantvoord, Jurjen J Luykx","doi":"10.1055/a-2406-6396","DOIUrl":"10.1055/a-2406-6396","url":null,"abstract":"","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"e1"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142146025","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}

{"title":"A Trajectory of Long-Term Antipsychotic Medication Dosage in Inpatients with Severe Behavioral and Psychological Symptoms of Dementia: A Retrospective Study.","authors":"Teruo Tada, Takefumi Suzuki, Yusuke Iwata, Masaharu Kubota, Koichiro Watanabe, Hitoshi Sakurai","doi":"10.1055/a-2336-3317","DOIUrl":"10.1055/a-2336-3317","url":null,"abstract":"<p><strong>Introduction: </strong>While antipsychotics are often prescribed for behavioral and psychological symptoms of dementia (BPSD), typically on an off-label basis, these medications have serious adverse effects. This study investigated the long-term use of antipsychotics among inpatients with dementia displaying severe BPSD, focusing on how prescriptions change over time.</p><p><strong>Methods: </strong>Medical charts at Kusakabe Memorial Hospital were retrospectively reviewed from October 2012 to September 2021. The study included patients diagnosed with dementia, admitted for BPSD, and were continuing antipsychotics at 3 months of their admission. Antipsychotic dosages were categorized as high (≥300 mg/d), medium (100-300 mg/d), and low (<100 mg/d) based on chlorpromazine equivalents and tracked until 15 months during hospitalization. Binary logistic regression was used to identify factors associated with dosage reductions between months 3 and 6.</p><p><strong>Results: </strong>This study involved 188 patients, with an average age of 81.2 years, 67% of whom were diagnosed with Alzheimer&apos;s dementia. At 3 months, 15.4% were taking high, 44.1% on medium, and 40.4% on low dosages of antipsychotics. The highest average dosage was observed at 3 months, with a subsequent decrease over time. By the 12th month, 20-30% of patients in all dosage categories had stopped their antipsychotic medication. Significant factors for dosage reduction included higher initial doses (OR 1.003, 95%Cl: 1.001-1.006, P=0.01) and male gender (OR 2.481, 95%Cl: 1.251-4.918, P=0.009).</p><p><strong>Discussion: </strong>A trajectory of antipsychotic dosage in inpatients with severe BPSD has rarely been reported. This research emphasizes the need for personalized strategies in managing long-term pharmacotherapy for this vulnerable group of patients.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"275-282"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451120","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}

{"title":"Twenty-Three Years of Declining Lithium Use: Analysis of a Pharmacoepidemiological Dataset from German-Speaking Countries.","authors":"Waldemar Greil, Mateo de Bardeci, Nadja Nievergelt, Sermin Toto, Renate Grohmann, Johanna Seifert, Georgios Schoretsanitis","doi":"10.1055/a-2374-2386","DOIUrl":"10.1055/a-2374-2386","url":null,"abstract":"<p><strong>Introduction: </strong>Pharmacoepidemiological data suggest that lithium prescriptions for bipolar disorder are gradually decreasing, with less attention having been paid to other indications.</p><p><strong>Methods: </strong>We examined lithium prescriptions between 1994 and 2017 in data provided by the Drug Safety in Psychiatry Program AMSP, including psychiatric hospitals in Germany, Austria and Switzerland. We compared lithium use for different diagnoses before and after 2001 and in three periods (T1: 1994-2001, T2: 2002-2009, and T3: 2010-2017).</p><p><strong>Results: </strong>In a total of 158,384 adult inpatients (54% female, mean age 47.4±17.0 years), we observed a statistically significant decrease in lithium prescriptions between 1994-2000 and 2001-2017 in patients with schizophrenia spectrum disorder from 7.7% to 5.1% and in patients with affective disorders from 16.8% to 9.6%. Decreases in use were also observed for diagnostic subgroups: schizoaffective disorder (ICD-10 F25: 27.8% to 17.4%), bipolar disorder (F31: 41.3% to 31%), depressive episode (F32: 8.1% to 3.4%), recurrent depression (F33: 17.9% to 7.5%, all: p<0.001) and emotionally unstable (borderline) personality disorder (6.3% to 3.9%, p=0.01). The results in T1 vs. T2 vs. T3 were for F25: 26.7% vs. 18.2% vs. 16.2%, F32: 7.7% vs. 4.2% vs. 2.7%, F33: 17.2% vs. 8.6% vs. 6.6% and for F31: 40.8% vs. 31.7% vs 30.0%, i. e. there was no further decrease for lithium use in bipolar disorder after 2002. Lithium's main psychotropic co-medications were quetiapine (21.1%), lorazepam (20.6%), and olanzapine (15.2%).</p><p><strong>Discussion: </strong>In inpatients, the use of lithium has decreased in patients with bipolar disorder and also with various other psychiatric diagnoses.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"296-303"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11543241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142036562","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}

{"title":"Recreational Cannabis Legalization: No Contribution to Rising Prescription Stimulants in the USA.","authors":"Garrett D Alexander, Luke R Cavanah, Jessica L Goldhirsh, Leighton Y Huey, Brian J Piper","doi":"10.1055/a-2334-6253","DOIUrl":"10.1055/a-2334-6253","url":null,"abstract":"<p><strong>Introduction: </strong>There have been substantial increases in the use of Schedule II stimulants in the United States. Schedule II stimulants are the gold standard treatment for attention-deficit hyperactivity disorder (ADHD), but also carry the risk of addiction. Since the neurocognitive deficits seen in ADHD resemble those of chronic cannabis use, and the rise in stimulant use is incompletely understood, this study sought to determine if recreational cannabis (RC) legalization increased distribution rates of Schedule II stimulants.</p><p><strong>Methods: </strong>The distribution of amphetamine, lisdexamfetamine, and methylphenidate were extracted from the ARCOS database of the Drug Enforcement Administration. The three-year population-corrected slopes of distribution before and after RC sales were evaluated.</p><p><strong>Results: </strong>Total stimulant distribution rates were significantly higher in states with RC sales after (<i>p</i>=0.049), but not before (<i>p</i>=0.221), program implementation compared to states without RC. Significant effects of time (<i>p</i><0.001) and RC sales status (<i>p</i>=0.045) were observed, while time x RC sales status interaction effects were not significant (<i>p</i>=0.406).</p><p><strong>Discussion: </strong>RC legalization did not contribute to a more pronounced rise in Schedule II stimulant distribution in states. Future studies could explore the impact of illicit cannabis use on stimulant rates and the impact of cannabis sales on distribution rates of non-stimulant ADHD pharmacotherapies and ADHD diagnoses.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"249-254"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141860524","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}

{"title":"SARS-CoV-2-Infection in People Addicted to Illegal Drugs - Is There a Protective Effect of Opioid Maintenance Treatment?","authors":"Simon Kurzhals, Martin Schäfer, Udo Bonnet, Katrin Isbruch, Stefan Kühnhold, Jörg Timm, Michael Specka, Norbert Scherbaum","doi":"10.1055/a-2345-7448","DOIUrl":"10.1055/a-2345-7448","url":null,"abstract":"<p><strong>Introduction: </strong>People addicted to illegal drugs were discussed as a risk group for SARS-CoV-2 infections, with increased susceptibility and a severe course of infection.</p><p><strong>Methods: </strong>In this study, the frequency of SARS-CoV-2 infections of drug-dependent persons admitted to inpatient detoxification treatment in five psychiatric hospitals was determined by implementing routine polymerase chain reaction (PCR)-testing at admission (9/2020) up to one year. Main substance-related diagnosis, comorbid respiratory disease, housing situation, and current opioid maintenance treatment (OMT) were documented. An age-matched control group of psychiatric inpatients without dependence from illegal drugs was established.</p><p><strong>Results: </strong>Data from 1675 patients (male 79.5%; mean age 39.5 years; opioid dependence 81.5% homelessness; 2.4%; chronic respiratory disease 6.3%) were included. Out of 1365 patients dependent on opioids, 50.2% were currently in OMT. Six (3 female; mean age 40.3 years) patients tested positive for SARS-CoV-2 by PCR (0.36%), and none showed symptoms of COVID-19. All six were opioid dependent, 5 currently not in OMT. In the control group, 11 out of 1811 inpatients tested positive (0.61%).</p><p><strong>Discussion: </strong>The rate of SARS-CoV-2-infections in persons with dependence on illegal drugs was not increased compared to a control group of psychiatric patients. OMT is presumably a protective factor, e. g. in the participating cities, OMT facilities offered an easy access to vaccination programs. In contrast, drug addicts in the USA were severely affected by the pandemic. Differences between countries might partially be explained by social factors such as the higher availability of OMT in Germany and a much lower frequency of homelessness.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"255-260"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875585","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}

{"title":"Discontinuation Rate of Lurasidone and Quetiapine Extended Release in Bipolar Depression.","authors":"Taro Kishi, Kenji Sakuma, Shun Hamanaka, Yasufumi Nishii, Nakao Iwata","doi":"10.1055/a-2331-2300","DOIUrl":"10.1055/a-2331-2300","url":null,"abstract":"<p><strong>Introduction: </strong>Lurasidone (LUR) was compared with quetiapine extended release (QUE-ER) regarding 1-year discontinuation in patients with bipolar depression (n=317).</p><p><strong>Methods: </strong>This is a retrospective cohort study.</p><p><strong>Results: </strong>Although the time to all-cause discontinuation was estimated using the Kaplan-Meier survival curve with log-rank tests to compare treatment groups, no difference was found (p=0.317). The Cox proportional hazard model revealed that only the presence of adverse events (AEs) is associated with increased treatment discontinuation (p<0.0001). The most common AEs were akathisia for LUR (17.7%) and somnolence for QUE-ER (34.7%). In other Cox models divided by LUR or QUE-ER, the presence of akathisia or somnolence was associated with increased LUR (p=0.0205) or QUE-ER (p<0.0001) discontinuation, respectively.</p><p><strong>Discussion: </strong>The acceptability of both antipsychotics to bipolar depression in clinical practice may be similar. However, specific AEs for each antipsychotic (LUR: akathisia and QUE-ER: somnolence) were associated with high treatment discontinuation.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"245-248"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141427309","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}

{"title":"Advancements in Non-Dopaminergic Treatments for Schizophrenia: A Systematic Review of Pipeline Developments.","authors":"Yuki Komatsu, Moe Takehara, Xenia Hart, Yuna Takahashi, Satoko Hori, Fumihiko Ueno, Hiroyuki Uchida","doi":"10.1055/a-2307-6484","DOIUrl":"10.1055/a-2307-6484","url":null,"abstract":"<p><strong>Introduction: </strong>Conventional antipsychotic drugs that attenuate dopaminergic neural transmission are ineffective in approximately one-third of patients with schizophrenia. This necessitates the development of non-dopaminergic agents.</p><p><strong>Methods: </strong>A systematic search was conducted for completed phase II and III trials of compounds for schizophrenia treatment using the US Clinical Trials Registry and the EU Clinical Trials Register. Compounds demonstrating significant superiority over placebo in the primary outcome measure in the latest phase II and III trials were identified. Collateral information on the included compounds was gathered through manual searches in PubMed and press releases.</p><p><strong>Results: </strong>Sixteen compounds were identified; four compounds (ulotaront, xanomeline/trospium chloride, vabicaserin, and roluperidone) were investigated as monotherapy and the remaining 12 (pimavanserin, bitopertin, BI 425809, encenicline, tropisetron, pregnenolone, D-serine, estradiol, tolcapone, valacyclovir, cannabidiol, and rimonabant) were examined as add-on therapy. Compared to the placebo, ulotaront, xanomeline/trospium chloride, vabicaserin, bitopertin, estradiol, cannabidiol, rimonabant, and D-serine showed efficacy for positive symptoms; roluperidone and pimavanserin were effective for negative symptoms; and encenicline, tropisetron, pregnenolone, tolcapone, BI 425809, and valacyclovir improved cognitive function.</p><p><strong>Discussion: </strong>Compounds that function differently from existing antipsychotics may offer novel symptom-specific therapeutic strategies for patients with schizophrenia.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"221-231"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140860277","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}

{"title":"Integrative Genetic Variation, DNA Methylation, and Gene Expression Analysis of Escitalopram and Aripiprazole Treatment Outcomes in Depression: A CAN-BIND-1 Study.","authors":"Farhana Islam, Amanda Lisoway, Edward S Oh, Laura M Fiori, Leen Magarbeh, Samar S M Elsheikh, Helena K Kim, Stefan Kloiber, James L Kennedy, Benicio N Frey, Roumen Milev, Claudio N Soares, Sagar V Parikh, Franca Placenza, Stefanie Hassel, Valerie H Taylor, Francesco Leri, Pierre Blier, Rudolf Uher, Faranak Farzan, Raymond W Lam, Gustavo Turecki, Jane A Foster, Susan Rotzinger, Sidney H Kennedy, Daniel J Müller","doi":"10.1055/a-2313-9979","DOIUrl":"10.1055/a-2313-9979","url":null,"abstract":"<p><strong>Introduction: </strong>Little is known about the interplay between genetics and epigenetics on antidepressant treatment (1) response and remission, (2) side effects, and (3) serum levels. This study explored the relationship among single nucleotide polymorphisms (SNPs), DNA methylation (DNAm), and mRNA levels of four pharmacokinetic genes, <i>CYP2C19</i>, <i>CYP2D6</i>, <i>CYP3A4</i>, and <i>ABCB1</i>, and its effect on these outcomes.</p><p><strong>Methods: </strong>The Canadian Biomarker Integration Network for Depression-1 dataset consisted of 177 individuals with major depressive disorder treated for 8 weeks with escitalopram (ESC) followed by 8 weeks with ESC monotherapy or augmentation with aripiprazole. DNAm quantitative trait loci (mQTL), identified by SNP-CpG associations between 20 SNPs and 60 CpG sites in whole blood, were tested for associations with our outcomes, followed by causal inference tests (CITs) to identify methylation-mediated genetic effects.</p><p><strong>Results: </strong>Eleven <i>cis-</i>SNP-CpG pairs (q<0.05) constituting four unique SNPs were identified. Although no significant associations were observed between mQTLs and response/remission, <i>CYP2C19</i> rs4244285 was associated with treatment-related weight gain (<i>q</i>=0.027) and serum concentrations of ESC_adj (<i>q</i><0.001). Between weeks 2-4, 6.7% and 14.9% of those with *1/*1 (normal metabolizers) and *1/*2 (intermediate metabolizers) genotypes, respectively, reported ≥2 lbs of weight gain. In contrast, the *2/*2 genotype (poor metabolizers) did not report weight gain during this period and demonstrated the highest ESC_adj concentrations. CITs did not indicate that these effects were epigenetically mediated.</p><p><strong>Discussion: </strong>These results elucidate functional mechanisms underlying the established associations between <i>CYP2C19</i> rs4244285 and ESC pharmacokinetics. This mQTL SNP as a marker for antidepressant-related weight gain needs to be further explored.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"232-244"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141451121","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}

{"title":"Comparable Psychotropic Prescription Rates After Hospital Discharge Between Patients with COVID-19 and Those With Non-COVID-19-Related Respiratory Infection.","authors":"Yuna Takahashi, Taisuke Yatomi, Naohito Yamaguchi, Kimio Yoshimura, Satoko Hori, Hiroyuki Uchida","doi":"10.1055/a-2286-1427","DOIUrl":"10.1055/a-2286-1427","url":null,"abstract":"<p><strong>Introduction: </strong>Whether psychiatric symptoms after recovery from coronavirus disease 2019 (COVID-19) are specific to this illness remains unclear.</p><p><strong>Methods: </strong>In this retrospective study, the Diagnosis Procedure Combination data and outpatient clinic data were used for patients who received inpatient treatment in Saiseikai-affiliated hospitals for COVID-19 or other respiratory tract infections (non-COVID) from 2020 to 2022. The primary outcome was new prescriptions of psychotropic drugs after discharge (i. e., prescriptions of psychotropics to patients who had not received them before or during their hospitalization). Values of interest were compared between groups using the chi-square test or Fisher's exact test. A COX proportional-hazards model was used to examine factors associated with psychotropic prescriptions after discharge in age- and sex-matched COVID-19 and non-COVID patients.</p><p><strong>Results: </strong>Of 31,993 chart records, 19,613 were excluded due to a positive history with psychiatric disorders (n=2,445), prescriptions of psychotropics (n=744), and no follow-ups (n=16,424). Thus, 3,648 COVID-19 and 8,732 non-COVID patients were included (mean [range] duration of follow-up, days: 146.9 [1-727] and 239.2 [1-729], respectively). Two hundred and four (5.6%) of the 3,648 patients with COVID-19 received psychotropic prescriptions after discharge. No statistically significant differences were observed in the prescription rates of any psychotropic category between the COVID-19 and non-COVID groups. An increase in severity during hospitalization was significantly associated with more frequent psychotropic prescriptions (hazard ratio 1.83, p<0.001).</p><p><strong>Discussion: </strong>The development of psychiatric symptoms should be closely observed, especially in patients who experienced increased severity during hospitalization, regardless of whether they suffered from COVID-19.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"186-190"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140294184","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}

{"title":"Cariprazine Orodispersible Tablet: A New Formulation for Cariprazine.","authors":"Viktória Meszár, Gabriella Magyar, Gabriella Mészárosné Pásztor, Balázs Szatmári, Krisztina Péter, Lívia Marton, Zsófia B Dombi, Ágota Barabássy","doi":"10.1055/a-2291-7130","DOIUrl":"10.1055/a-2291-7130","url":null,"abstract":"<p><strong>Introduction: </strong>Cariprazine is an atypical dopamine receptor partial agonist antipsychotic available in the form of capsules. Although capsules are one of the most desirable routes of administration, there are certain situations (e. g., in an acute psychiatric setting, or when swallowing difficulties, or liquid shortages are present) when they cannot be administered. Therefore, alternative solutions like orodispersible tablets are needed. This study aimed to investigate the bioequivalence of a newly developed orodispersible tablet to the commercially available hard gelatine capsule of cariprazine 1.5 mg.</p><p><strong>Methods: </strong>This was a phase I, open-label, randomized, single-dose bioequivalence study. It had a 2-period, 2-sequence, cross-over design, where each subject received one test and one reference product in a randomized sequence, separated by a wash-out period of 55 days. Blood sampling was performed over 72 h after dosing. Cariprazine concentrations were analyzed by a validated HPLC-MS/MS method. Standard bioequivalence statistics was applied to PK parameters calculated by non-compartmental analysis. Safety measures were analyzed descriptively.</p><p><strong>Result: </strong>Pharmacokinetic data of 43 healthy volunteers and safety data of 54 subjects was analyzed. Cariprazine AUC_0-72h and C_max geometric mean ratios were 117.76% and 100.88%, respectively. The 90% confidence intervals were within the pre-defined bioequivalence acceptance limits of 80.00% - 125.00%. Safety data was in line with the Summary of Product Characteristics of Cariprazine.</p><p><strong>Discussion: </strong>The result of this clinical trial proved the bioequivalence of the new orodispersible tablet formulation when compared to hard gelatine capsules, enabling an alternative option for treatment of those suffering from schizophrenia.</p>","PeriodicalId":19783,"journal":{"name":"Pharmacopsychiatry","volume":" ","pages":"180-185"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11233223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140874766","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}