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Methods of treating schizophrenia

A schizophrenia, symptom technology, applied in the field of treatment of schizophrenia, can address the unmet needs of negative symptoms and cognitive dysfunction effective treatment

Active Publication Date: 2020-01-10
SUNOVION PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, relatively effective treatments for negative symptoms and cognitive impairment remain an unmet need

Method used

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  • Methods of treating schizophrenia
  • Methods of treating schizophrenia
  • Methods of treating schizophrenia

Examples

Experimental program
Comparison scheme
Effect test

specific example

[0313] Specific examples include, but are not limited to, the following compounds:

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[0318] In one embodiment, R 1 and R 2 Together with the nitrogen atom to which they are attached, form a heteroaryl or heterocyclyl, each optionally substituted. In one embodiment, R 1 and R 2 Together with the nitrogen atom to which they are attached, an optionally substituted heterocyclyl is formed. In one embodiment, R 1 and R 2 Together with the nitrogen atom to which they are attached, form a heteroaryl or heterocyclyl group. Examples include, but are not limited to, azetidinyl, pyrrolidinyl, piperidinyl, azepanyl, morpholinyl, imidazolyl, piperazinyl, and N-methyl-piperazinyl. Specific examples include, but are not limited to, the following compounds:

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[0321] In one embodiment, R1 and R 3 Together with the atoms to which they are attached, an optionally substituted heterocyclyl ring is formed (eg, pyrrolidi...

Embodiment 1

[0511] Example 1: Verification of the transformation matrix

[0512] By calculating the transformed PANSS factor scores for all subjects in 12 additional clinical trials ("validation study" data set) not included in the analyzed samples (PANSS analysis study) in the lurasidone database, Investigate the robustness and general applicability of the findings for use in deriving Figure 4 and score matrix of Table 4A. The other 12 clinical trials included a short-term acute schizophrenia study, an open-label study, a long-term extension study, and a randomized withdrawal study. For each study in the validation dataset, total variance of transformed PANSS factors (high r-squared value between sum of transformed PANSS factors and PANSS total score), specificity / orthogonality (low difference between individual transformed PANSS factors correlation) and high surface validity (high agreement with the MarderPANSS factor).

[0513] All study patients were adults with schizophrenia, exc...

Embodiment 2

[0524] Example 2: Lurasidone Subdomains

[0525] The validation study data of Example 1 were used to transform the PANSS factors to compare the treatment effects of an antipsychotic (lurasidone) on established schizophrenia symptom domains with those estimated using the Marder PANSS factors. The height of the total variance indicated that the effect sizes for the transformed PANSS factor and the sum of the PANSS sums were almost the same (between transformed PANSS and untransformed PANSS factors), suggesting that estimates of drug effects on schizophrenia symptoms did not vary between methods.

[0526] Figure 3A Baseline and Week 6 (within treatment) effect sizes were compared for lurasidone and placebo, estimated using the Marder PANSS factor (left panel) and the transformed PANSS factor (right panel). In the left panel, for lurasidone in all Marder PANSS factors, a consistent pattern within treatment groups of moderate to high pre, effect sizes (0.5 to 1.1) was observed. ...

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Abstract

Provided herein are methods for determining if a compound has potential efficacy for the treatment for a specific symptom domain of schizophrenia, such as for example, the treatment of a negative symptom of schizophrenia. In addition, provided herein are methods of determining the prominent symptom domain of a subject suffering from schizophrenia. Further, provided herein are various methods for the treatment of the negative symptoms, cognitive dysfunction symptoms, or both, associated with schizophrenia comprising administering to a subject a therapeutically or prophylactically effective amount of various compounds.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 459,784, filed February 16, 2017, the contents of which are hereby incorporated by reference in their entirety. technical field [0003] Provided herein are methods for treating schizophrenia, as well as various compounds and compositions comprising the same for this purpose. Background technique [0004] CNS disorders of varying severity affect a wide range of populations. Typically, the main features of such disorders include marked impairment of cognition or memory, which manifests as a marked deterioration from previous levels of functioning. [0005] Schizophrenia is a psychotic disorder of unknown origin that usually first appears in early adulthood and has features such as psychotic symptoms, phasic progression and development, and / or deterioration in social behavior and professional competence. Schizophrenia is also a chronic and d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/381A61K31/435A61K31/55C07D333/76C07D333/78C07D495/04C07D495/20C07D277/60A61P25/18
CPCA61K45/06A61K31/381A61K31/435A61K31/55C07D333/76C07D333/78A61P25/18C07D333/54A61K31/4535C07D495/04A61K31/5377A61K31/4436A61K31/4178A61K31/496C07D495/12
Inventor S·霍普金斯K·柯布兰A·勒贝尔A·奥格拉
Owner SUNOVION PHARMA INC