Emerging pharmacological therapies in schizophrenia: what’s new, what’s different, what’s next?

Citrome, Leslie

doi:10.1017/s1092852916000729

Cited by 15 publications

(11 citation statements)

References 51 publications

(64 reference statements)

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“…Schizophrenia, a relatively common and chronic psychotic disorder, is notable for its marked heterogeneity in disease course and response to treatment, as well as differences among currently available psychopharmacological interventions. 1 – 3 New medications are welcomed, in the hope that they can address the shortcomings of prior drugs in terms of both therapeutic targets 4 and tolerability profile. 5 …”

Section: Introductionmentioning

confidence: 99%

Cariprazine for acute and maintenance treatment of adults with schizophrenia: an evidence-based review and place in therapy

Citrome¹

2018

NDT

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Cariprazine is an oral antipsychotic approved in the US and EU for the treatment of schizophrenia. Cariprazine differs from other antipsychotics in that it is a dopamine D3- and D2-receptor partial agonist, with tenfold higher affinity for D3 receptors than for D2 receptors. Cariprazine is metabolized in two steps by CYP3A4 to didesmethyl-cariprazine (DDCAR). DDCAR has a long half-life of 1–3 weeks and is the predominant circulating active moiety. Efficacy and safety in persons with acute schizophrenia were assessed in four similarly designed, short-term, randomized, placebo-controlled clinical trials in nonelderly adults, with three studies considered positive and yielding a number needed to treat vs placebo for response (change from baseline ≥30% in Positive and Negative Syndrome Scale total score) of ten for the approved dose range of cariprazine 1.5–6 mg/day. The most common adverse reactions were extrapyramidal symptoms (15% and 19% for 1.5–3 and 4.5–6 mg/day, respectively, vs 8% for placebo) and akathisia (9% and 12.5% for 1.5–3 and 4.5–6 mg/day, respectively, vs 4% for placebo). For the approved dose range, rates of discontinuation because of an adverse event were lower overall for patients receiving cariprazine vs placebo (9% vs 12%). Weight and metabolic profile appear favorable. Cariprazine does not increase prolactin levels or prolong the electrocardiographic QT interval. Cariprazine has also been found to be effective for the maintenance treatment of schizophrenia by delaying time to relapse when compared with placebo (HR 0.45). A 26-week randomized clinical trial evidenced superiority of cariprazine over risperidone for the treatment of predominantly negative symptoms in patients with schizophrenia. Cariprazine is also approved in the US for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and is being studied for the treatment of bipolar I depression and major depressive disorder.

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Section: Introductionmentioning

confidence: 99%

Cariprazine for acute and maintenance treatment of adults with schizophrenia: an evidence-based review and place in therapy

Citrome¹

2018

NDT

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“…The proportional decrease with regard to psychotic disorders may be paralleled by the increase in organic disorders' research, boosted by dementia, delirium and mild cognitive disorder, notwithstanding that schizophrenia remains the 2 nd most investigated disorder, having several new medications on the market (Citrome, 2016). The decline of alcohol use disorders' investigation through RCTs, when it remains a public health issue, may be due to the lack of new medication candidates for clinical trials (Canella et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

The Main Gaps for Randomized-controlled Trials in Psychiatry: A Bibliometric Study

et al. 2020

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BackgroundThere is evidence of a progressive increase in the number of Randomized Controlled Trials (RCTs) in the area of psychiatry. However, some areas of psychiatry receive more attention from researchers potentially to the detriment of others.MethodsAiming to investigate main gaps for RCTs in psychiatry, the present bibliometric study analysed the bi-annual and five-year rates of RCTs in the main database of medical studies (Pubmed) over the 1999–2018 period (n = 3,449). This analysis was carried out using the ICD-10 mental and behavioural chapter. ICD-10, was the edition of the manual used throughout the above period.ResultsOverall, after 16 years of considerable increase in the bi-annual absolute number of RCTs, there has been a slowdown in the last 4 years, similar to other medical areas. Affective, organic and psychotic disorders, and depression, schizophrenia and dementia were the top studied groups and disorders respectively – ahead of other groups/diagnoses. For substance use disorders, there has been a decrease of RCT in the last 5 years, in line with the fall of alcohol use disorder in the ranking of most studied disorders. Delirium and mild cognitive disorder are both ascending in this ranking. Personality disorders and mental retardation stand out as the least studied groups over the whole assessment period.ConclusionNovel treatments, ease of access to patient populations, and ‘clinical vogue’, seem to be more important in guiding the undertaking of RCTs than the actual need as indicated by prevalence and/or burden of disorders and public health impact. Regarding specific disorders, acute/transient psychosis; mixed anxiety and depression; adjustment disorder; dissociative and conversion disorders; somatization; hypochondria; and neurasthenia, would deserve future RCTs. Clinical researchers and editors of scientific journals should give special attention to the less studied areas and disorders, when considering conducting and publishing RCT studies, respectively.

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“…However, because lumateperone offers great promise to alleviate the suffering of people with schizophrenia, we seek to share our objective Introduction to the compound Lumateperone is an orally administered, atypical antipsychotic developed by Intra-Cellular Therapies (New York, NY, USA) for the treatment of schizophrenia and other neurologic and neuropsychiatric disorders. 35 Lumateperone is the first in class selective and simultaneous modulator of dopamine, serotonin, and glutamate, 5,18,22,30,32,[36][37][38][39][40][41] approved by the US Food and Drug Administration for the treatment of schizophrenia. 42…”

Section: Data Sources and Searchesmentioning

confidence: 99%

The role of lumateperone in the treatment of schizophrenia

Syed

Brašić

2021

Therapeutic Advances in Psychopharmacology

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Schizophrenia is a devastating mental disorder resulting in marked morbidity and mortality despite the optimal use of all currently available interventions. For this reason, the release of lumateperone (CaptylaR), also known as ITI-007, an orally administered, atypical antipsychotic provided a welcome novel tool for clinicians to utilize precision medicine to tailor an optimal treatment plan to the specific needs of each person with schizophrenia. To generate a foundation for clinicians to assess the risks and benefits of lumateperone in relation to other interventions for schizophrenia, we conducted a search of items for ‘ITI-007’ and ‘lumateperone’ on PubMed, ScienceDirect, Web of Science, Google Scholar, and www.clinicaltrials.gov . We present a critical evaluation of the limited information about lumateperone for schizophrenia, its use approved by the US Food and Drug Administration. Lumateperone merits consideration for patients with treatment-resistant schizophrenia and for patients with schizophrenia who are vulnerable to developing metabolic dysfunction and movement disorders. On the other hand, lumateperone should not be used for (a) women who are pregnant or breastfeeding, children, adolescents, and elderly patients with dementia-related psychosis, (b) patients who are at risk for cerebrovascular diseases, (c) patients who use inducers and moderate or strong inhibitors of the cytochrome P450-3A4 (CYP3A4) isozyme, and (d) patients who use alcohol and other sedating agents. Clinical trials from multiple centers without financial conflicts of interest to market lumateperone are needed to directly compare and contrast lumateperone and other antipsychotic agents to generate trustworthy evidence to be assessed objectively by clinicians treating patients with schizophrenia. Future investigations will provide the foundations to identify the evidence for comprehensive evaluations of the role of lumateperone in the treatment of people with schizophrenia and other conditions.

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Emerging pharmacological therapies in schizophrenia: what’s new, what’s different, what’s next?

Cited by 15 publications

References 51 publications

Cariprazine for acute and maintenance treatment of adults with schizophrenia: an evidence-based review and place in therapy

Cariprazine for acute and maintenance treatment of adults with schizophrenia: an evidence-based review and place in therapy

The Main Gaps for Randomized-controlled Trials in Psychiatry: A Bibliometric Study

The role of lumateperone in the treatment of schizophrenia

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