- |||||||||| lurasidone / Generic mfg.
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression (clinicaltrials.gov) - Nov 15, 2022
P3, N=124, Active, not recruiting,
However, further molecular studies with selective receptor agonists are necessary to find out which individual monoaminergic receptors/signaling pathways are involved in the regulation of the rat CYP2D4 and human CYP2D6 enzyme in particular brain structures. Recruiting --> Active, not recruiting | N=362 --> 124 | Trial completion date: Sep 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022
- |||||||||| lurasidone / Generic mfg.
Trial completion date, Trial primary completion date: ELICE_BD: Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients (clinicaltrials.gov) - Nov 2, 2022
P3, N=150, Recruiting,
Recruiting --> Active, not recruiting | N=362 --> 124 | Trial completion date: Sep 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022 Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| lithium carbonate ER / Generic mfg.
Pharmacologic and Psychotherapeutic Treatments for Pediatric Bipolar Depression () - Oct 19, 2022 - Abstract #AACAP2022AACAP_1344;
Quetiapine immediate release (IR) and extended release (ER) did not show a statistically significant improvement in the symptoms of bipolar depression compared to placebo...Lurasidone and the olanzapine-fluoxetine combination are evidence-based treatments for pediatric bipolar depression. There are several evidence-based therapies for pediatric bipolar depression, and there is a need for more research on the pharmacologic treatment of pediatric bipolar depression.
- |||||||||| Know Your CYPs! Meaningful Cytochrome p450 Interactions in the Treatment of Psychosis () - Oct 19, 2022 - Abstract #AACAP2022AACAP_286;
Some CYP1A2 substrates include olanzapine, clozapine, propranolol, and caffeine...Conclusions Many medications prescribed for patients experiencing early psychosis have important cytochrome p450 interactions. Knowledge of these interactions is important for providers at all levels.
- |||||||||| Metabolic Acidosis in a Patient With Polycystic Ovary Syndrome Taking Oral Contraceptives and Antipsychotics (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_2892;
Her home medications included lurasidone, sertraline, ethinyl estradiol-norgestimate, metformin, and insulin...Acetaminophen, ethanol, and salicylate levels were negative...She was discharged with OCP containing less estrogen, insulin, statin, omega-3 and fenofibrate...After plasmapharesis and hemodialysis with reduction of triglyceride levels, our patient's HAGMA resolved. There have been a few cases reported of oral contraception-induced hypertriglyceridemia particularly with estrogen, but requires further research.
- |||||||||| ulotaront (SEP-363856) / Sumitomo Pharma, Otsuka, dasotraline (SEP-225289) / Sumitomo Dainippon, Aptiom (eslicarbazepine) / Sumitomo Dainippon, BIAL
Novel algorithm using incidence and duration to calculate adverse event prevalence in randomized controlled trials (Corner 1 (Hall X1) [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_1579;
Whereas the benefits of drug treatment are evaluated by dedicated efficacy measures analyzed using common statistical Methods, use of analysis Methods beyond standard incidence tables for AE data in RCTs are less commonplace. Combining AE incidence with duration offers a new way to evaluate risk to patients for treatment vs. non-treatment.
- |||||||||| Antipsychotic prescribing trends in schizophrenia between 2011 and 2021: real-world data from a US electronic health record database (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_1102;
Paliperidone, fluphenazine, clozapine and lurasidone were also amongst the most frequently prescribed antipsychotics, although the frequency of prescription was much lower for these medications (2.4–3.9%)...Overall, real-world data can generate insights on the degree to which clinical prescribing practises reflect clinical guidelines. Table 1. Antipsychotic prescriptions between 2011–2021AntipsychoticN*Risperidone1182Olanzapine613Haloperidol547Quetiapine546Aripiprazole471Other319Clozapine165Paliperidone145Lurasidone138Fluphenazine103*n=4229 antipsychotic prescriptions across 3,642 patients.
- |||||||||| lithium carbonate ER / Generic mfg., lurasidone / Generic mfg.
The effect of lurasidone on anhedonia in adult patients with bipolar depression (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_960;
P3
A significant percent (48.4%; Wald 95% CI, 22.8, 74.0) of the lurasidone effect on improvement on the SDS total score was also mediated by improvement in the item-8 anhedonia score (P<0.0005). Conclusion : The Result s of this post-hoc analysis suggest that lurasidone treatment may be associated with improvement in anhedonia in patients with a diagnosis of bipolar I disorder who present with moderate-to-severe major depressive episodes. Improvement in both quality of life and functioning appeared to be largely mediated by improvement in anhedonia, indicating that the amelioration of patients’ pervasive inability to feel pleasure or take interest in their environment is an important therapeutic target.
- |||||||||| lurasidone / Generic mfg.
Vulnerability of female rats to chronic mild stress exposure: the role of microglia and the modulation by chronic lurasidone treatment (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_933;
Furthermore, we found a strong association between the vulnerability to CMS exposure and the inflammatory and immune-related mechanisms within different hippocampal subfields. Chronic lurasidone treatment was highly effective in counteracting most of these alterations suggesting that its ability to interfere with inflammatory changes may represent a novel element for its clinical effectiveness in the treatment of mental disorders.
- |||||||||| fluoxetine / Generic mfg., lurasidone / Generic mfg.
Augmentation strategy fluoxetine and lurasidone in the treatment of obsessive-compulsive disorder with comorbid restrictive anorexia nervosa – a case report (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_920;
Lurasidone is a second-generation antipsychotic with good efficacy and lower metabolic and cardiovascular side effects if compared with other SGAs, but there is currently brief experience about its use in treatment of OCD, especially whereas comorbid anorexia nervosa- restrictive type (AN-r) is present. Objective: This Case Report presents the effect of augmentation strategy with lurasidone (37 mg daily bedtime) in a 45-years old woman with a relapse episode of severe OCD with comorbid AN-r, previously treated with combined fluoxetine and olanzapine treatment, subsequently interrupted. During the first visit to our psychiatric clinic the patient was provided self- and hetero-administered assessment with Yale-Brown Obsessive Compulsive Scale (Y-BOCS-II), Clinical Global Impression-Severity (CGI-S), Symptom Checklist-90 (SCL-90) and Eating Disorder Inventory-3 (EDI-3)...The management of this clinical case demonstrates a possible indication of lurasidone as augmentation strategy in tr-OCD. Nevertheless, further longitudinal and real-world effectiveness studies are needed to confirm effectiveness in attenuating OC symptomatology, in tr-OCD and whereas a comorbid AN-r is present.
- |||||||||| Risperdal Consta (risperidone depot formulation) / J&J
Second-generation antipsychotics during pregnancy: what is new? (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_917;
In case it is necessary to change therapy, aripiprazole is a good option. Both risperidone and paliperidone should be used with caution and never as first line.
- |||||||||| lurasidone / Generic mfg.
High dose lurasidone for the treatment of psychosis – a case series (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_844;
Moreover, it was effective for anxiety, insomnia and depression.The mean time for response was close to 2 weeks, and it was well tolerated. To sum up, high dose lurasidone is a well tolerated and effective treatment for psychosis and is specially useful when it is accompanied of insomnia, anxiey or depression.
- |||||||||| ulotaront (SEP-363856) / Sumitomo Pharma, Otsuka
Review of the TAAR1 agonist ulotaront: Part II - summary of initial clinical efficacy/safety results (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_825;
The safety and tolerability profile of ulotaront is markedly different with respect to class-related AEs that are characteristic of both first- and second-generation antipsychotics. The benefit-risk profile of ulotaront, as a member of thel TAAR1 agonist class, is distinguished from antipsychotics by lack of D2 and 5-HT2A receptor blockade.
- |||||||||| ulotaront (SEP-363856) / Sumitomo Pharma, Otsuka, dasotraline (SEP-225289) / Sumitomo Dainippon, Aptiom (eslicarbazepine) / Sumitomo Dainippon, BIAL
Novel algorithm using incidence and duration to calculate adverse event prevalence in randomized controlled trials (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_728;
Whereas the benefits of drug treatment are evaluated by dedicated efficacy measures analyzed using common statistical Methods, use of analysis Methods beyond standard incidence tables for AE data in RCTs are less commonplace. Combining AE incidence with duration offers a new way to evaluate risk to patients for treatment vs. non-treatment.
- |||||||||| lurasidone / Generic mfg.
Effect of lurasidone on depressive symptoms, function, and quality of life outcomes: a post-hoc multiple responder analysis (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_676;
P3
Patients with bipolar depression treated with lurasidone demonstrated statistically significant and clinically meaningful response not only for improvement in depressive symptoms alone, but also in combination with improvement in functional and quality of life measures. Inclusion of these multi-dimensional, patient-centered outcome measures are important to patients in their journey to overall recovery.
- |||||||||| Clinical, Journal: Lamotrigine-induced mania: warning report for the identification of vulnerable populations and expert clinical recommendations for prescription. (Pubmed Central) - Oct 12, 2022
A 38-year-old man, stabilized with asenapine due to a brief psychotic episode, presented depressive symptoms and LTG was titrated up to 200 mg/day in 6 weeks...LTG was withdrawn and he was treated with lithium and lurasidone...LTG was suspended and aripiprazole increased...LTG-induced mania may be more likely to happen in patients with BD-I, manic predominant polarity, an index manic episode, or those with a history of the antidepressant manic switch. Therefore, in BD patients with the aforementioned risk factors, LTG use should be carefully managed: starting with low doses, extending tapering lengths, using adjunctive treatments and close monitoring manic symptoms.
- |||||||||| lurasidone / Generic mfg.
Journal, HEOR: Cost-utility analysis of lurasidone for the first-line treatment of schizophrenia in China. (Pubmed Central) - Oct 4, 2022
Probabilistic sensitivity analyses suggested that lurasidone had 99.7, 99.9, and 100% probability of being cost-effective vs. olanzapine and risperidone at the conventional decision thresholds of 1, 2, and 3 times the Chinese per capita gross domestic product [namely CN¥72,447.00 (US$10,499.57)/QALY, CN¥1,44,894.00 (US$20,999.13)/QALY, and CN¥2,17,341.00 (US$31,498.70)/QALY in 2020], respectively. Treatment with lurasidone was predicted to improve health outcomes and be a dominant strategy for patients with schizophrenia, compared with olanzapine and risperidone, in China.
- |||||||||| Review, Journal: Antipsychotic Safety in Liver Disease: A Narrative Review and Practical Guide for the Clinician. (Pubmed Central) - Oct 1, 2022
Antipsychotic selection, dosing, monitoring, and counseling should be individualized based on whether a patient has existing liver disease and if they are receiving an agent that poses a higher risk of liver injury. The consult-liaison psychiatry provider can guide the primary team in management through thoughtful integration of the known pathophysiologic changes in hepatic disease and risk-benefit analysis of antipsychotic safety profiles.
- |||||||||| Review, Journal: New Atypical Antipsychotics in the Treatment of Schizophrenia and Depression. (Pubmed Central) - Oct 1, 2022
We then shortly discuss efficacy, safety and limitations of ongoing pharmacotherapy used in depression and schizophrenia. Mainly, we have focused this review on the therapeutic potential of new atypical antipsychotic drugs-currently existing-to be effective in psychotic, as well as in affective disorders.
- |||||||||| lurasidone / Generic mfg.
Journal: Sleep Disturbance and Bipolar Depression in Youth. (Pubmed Central) - Oct 1, 2022
The effects of these bridge symptoms on the response to lurasidone 20-80 mg/d compared to placebo treatment was analyzed in children and adolescents with bipolar I depression in a six-week, placebo-controlled, double-blind study followed by a 2-year, open- label extension study of lurasidone...The absence of sleep disturbance and irritability in patients at open-label extension study baseline was associated with higher rates of sustained recovery (symptomatic and functional remission) for 6 months compared to patients with those symptoms at baseline (68% vs. 50%, Number Needed to Treat=6). Our findings suggest that sleep disturbance and irritability are cardinal symptoms that "bridge" between depressive and manic symptom clusters and influence treatment outcomes in youth with bipolar depression.
- |||||||||| PK/PD data, Review, Journal: Racial/Ethnic Differences in the Pharmacokinetics of Antipsychotics: Focusing on East Asians. (Pubmed Central) - Sep 24, 2022
In this study, we determined the racial or ethnic differences in the metabolic patterns of some selected antipsychotics by reviewing therapeutic drug monitoring studies in East Asian populations. The plasma concentrations of haloperidol, clozapine, quetiapine, aripiprazole, and lurasidone, which are metabolized by specific CYP enzymes, were determined to be higher, under the same daily dose, in East Asian populations than in Western populations.
- |||||||||| lurasidone / Generic mfg.
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study. (clinicaltrials.gov) - Sep 22, 2022
P=N/A, N=9, Terminated,
The plasma concentrations of haloperidol, clozapine, quetiapine, aripiprazole, and lurasidone, which are metabolized by specific CYP enzymes, were determined to be higher, under the same daily dose, in East Asian populations than in Western populations. N=200 --> 9 | Trial completion date: Dec 2022 --> Mar 2022 | Recruiting --> Terminated | Trial primary completion date: Oct 2022 --> Feb 2022; Recruitment was not completed
- |||||||||| Novel Antipsychotics and Risk of Drug-Induced Movement Disorders and Tardive Syndromes (Poster Station: 21) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_501;
Compared to oral paliperidone, the LAI may decrease risk of DIMDs while LAI risperidone and aripiprazole have equal risk compared to oral formulations. Furthermore, new experimental drug targets that do not use dopamine receptor blockade show promise in reducing incidence of DIMDs.
- |||||||||| lurasidone / Generic mfg.
Clinical, Journal: Lurasidone for Adolescents With Complex Mental Disorders: A Case Series. (Pubmed Central) - Sep 21, 2022
Lurasidone deserves further study for its use in the adolescent population (outside the remit of FDA) given its potential more favorable risk-benefit profile in young people. The favorable tolerability appear to be borne out by the pharmacodynamic predictions in our complex patients who would be excluded in formal clinical trial studies.
- |||||||||| lurasidone / Generic mfg.
Journal: Therapeutic Drug Monitoring of Lurasidone. (Pubmed Central) - Sep 7, 2022
Closer multi-agency collaboration may bridge the gap between evidence, guidelines and approved drugs. No abstract available
- |||||||||| Vraylar (cariprazine) / Mitsubishi Tanabe, Recordati, Gedeon Richter, AbbVie
Current Issues and Expected Challenges in Identification of Depression as a Cardinal Symptom Within Bipolar Disorder (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_2441;
The current standard of care is associated with limited efficacy and numerous adverse effects. With prevalence continuing to rise, it is incumbent for relevant stakeholders to develop methods to distinguish bipolar depression and manage the disease with increased efficacy and safety to reduce morbidity and mortality.
- |||||||||| lurasidone / Generic mfg.
Budget Impact Analysis of Lurasidone in the Treatment of Adult and Adolescent Patients With Schizophrenia in Spain (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1681;
With prevalence continuing to rise, it is incumbent for relevant stakeholders to develop methods to distinguish bipolar depression and manage the disease with increased efficacy and safety to reduce morbidity and mortality. As lurasidone is the only AA authorized in patients aged 13-14 years, its availability on the Spanish market allows the treatment of 1,424 extra patients (aged 13-14 years), still generating €-197,610 savings, which consequently would allow the treatment of 103 additional patients.
- |||||||||| lurasidone / Generic mfg., quetiapine / Generic mfg.
Journal: Diagnosis and Treatment of Bipolar Illness in the Primary Care Office. (Pubmed Central) - Aug 30, 2022
For bipolar maintenance therapy, lamotrigine, valproic acid, and lithium are first line options. Finally, nonpharmacologic interventions including psychoeducation can be extremely helpful for patients and their families to successfully participate in the management of their disease.
- |||||||||| lurasidone / Generic mfg.
Journal: Exposure to chronic stress impairs the ability to cope with an acute challenge: Modulation by lurasidone treatment. (Pubmed Central) - Aug 18, 2022
Furthermore, when investigating the activation of different brain regions, CMS rats showed an impairment in the global response to the acute stressor, that was largely restored by lurasidone treatment. Our results suggest that lurasidone treatment in CMS rats may regulate specific circuits and mechanisms, which will ultimately contribute to boost resilience under stressful challenges.
- |||||||||| Caplyta (lumateperone) - Intra / Cellular Therapies
Journal: Lumateperone (Caplyta) for bipolar depression. (Pubmed Central) - Aug 11, 2022
Recruiting --> Active, not recruiting | Phase classification: P2/3 --> P3 | Trial completion date: Apr 2022 --> Sep 2023 | Trial primary completion date: Mar 2022 --> Jun 2023 No abstract available
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Trial completion: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Aug 9, 2022
P2/3, N=8, Completed,
No abstract available Withdrawn --> Completed
- |||||||||| lurasidone / Generic mfg.
SPONSORED SESSION (NOT INCLUDED IN MAIN EVENT CME/CPD CREDIT) (AMBER 2-3 - LIVE STREAMED) - Aug 9, 2022 - Abstract #WPA2022WPA_946;
Meet the Expert Session -Sponsored by SUMITOMO PHARMA ASIA PACIFICBeyond Clinical Remission: Achieving Functional Recovery & Improvement of QoL in Patients with Bipolar DisorderKey lecture contents: Psychosocial functioning recovery: what does it means & why does it matters? Importance of managing patients' & caregivers' expectation in achieving functional recovery Monitoring functioning improvement & quality of life in clinical practice Review of current evidence of bipolar disorder treatment modalities targeting for improvement of psychosocial functioning and quality of life including evidence of antipsychotics (e.g., lurasidone clinical data) and future of other treatment modalities
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