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  1. Article ; Online: Clinical implication of children's depression rating scale-revised score: Linking the children's depression rating scale-revised score and clinical global impression using patients data from clinical trials.

    Yoshimatsu, Hiroki / Imaeda, Takayuki / Higa, Shingo / Nomoto, Keisuke

    Health science reports

    2023  Volume 6, Issue 9, Page(s) e1512

    Abstract: Background and aims: The Children's Depression Rating Scale-Revised (CDRS-R) score has been widely used to assess the severity of major depression in children and adolescents; however, the clinical implications of changes in the CDRS-R score remain ... ...

    Abstract Background and aims: The Children's Depression Rating Scale-Revised (CDRS-R) score has been widely used to assess the severity of major depression in children and adolescents; however, the clinical implications of changes in the CDRS-R score remain unclear. We evaluated these clinical implications by assessing the relationship between changes in the CDRS-R score and changes in the Clinical Global Impression of Improvement (CGI-I), in clinical research on major depression.
    Methods: We used data from four clinical trials involving two antidepressants and evaluated the relationship between CDRS-R score changes and the CGI-I score using the equipercentile linking method.
    Results: CDRS-R score changes corresponding to a minimally improved (score of 3) CGI-I score was approximately 14 points.
    Conclusion: Our findings from the linking analyses are useful for interpreting the clinical implications of changes in the CDRS-R score.
    Language English
    Publishing date 2023-08-31
    Publishing country United States
    Document type Journal Article
    ISSN 2398-8835
    ISSN (online) 2398-8835
    DOI 10.1002/hsr2.1512
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: A Sponsor's Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan.

    Wolter, Kevin D / Kamatani, Asayuki / Suzuki, Yumiko / Imaeda, Takayuki / Dagher, Ramzi / Safferman, Allan / Junor, Rod

    Pharmaceutical medicine

    2024  

    Abstract: Background: Following marketing authorization in Japan, for almost all new drugs or new indications, postmarketing studies (PMS) are a regulatory requirement. These PMS focus on accrual of a defined number of cases with data being collected for a ... ...

    Abstract Background: Following marketing authorization in Japan, for almost all new drugs or new indications, postmarketing studies (PMS) are a regulatory requirement. These PMS focus on accrual of a defined number of cases with data being collected for a predetermined period after approval to confirm efficacy/effectiveness, safety, and quality in the Japanese population. In contrast to other regions where PMS are only required to address a specific scientific uncertainty, in Japan, PMS are often required regardless of any specific scientific uncertainty, and therefore, their scientific value is unclear.
    Objectives: To determine the contribution to the understanding of benefit/risk of PMS conducted by Pfizer in Japan over 2000-2020 for Pharmaceuticals and Medical Devices Agency (PMDA) reexamination.
    Methods: A retrospective analysis of all Pfizer Japan postmarketing studies (PMS) during 2000-2020 was performed. Available Pfizer clinical study reports (CSRs) and PMDA reexamination reports (RERs) were reviewed for key safety findings. The primary analysis was conducted on the subset of PMS that had both an English CSR and a discussion of that PMS in the relevant RER issued by the PMDA, which was subsequently translated into English by a professional translation vendor. Reexamination outcome is included in each RER and served to demonstrate the impact of the study of the benefit/risk profile of the drug.
    Results: A total of 79 PMS for 43 different drug products across therapy areas enrolled a total of 98,035 patients. The 79 PMS comprised 34 general drug use investigation (GDUI) studies and 45 special investigation (SI) studies. The primary analysis involved 37 PMS with a CSR and RER available in English (40,470 patients); all of which were observational in design. For 31 of 37 PMS, the RER concluded the overall adverse drug reaction (ADR) rate in the PMS was nominally lower than in the phase 3 program. Unlabeled ADRs were reported in 28 of 37 PMS; however, no new safety concerns requiring regulatory action arose from any PMS. The PMDA did not require additional risk minimization measures for any of the 43 drug products studied in any of the 79 PMS assessed. Japan PMS data were consistent with prior global data with no evidence of clinically meaningful differences in safety in Japanese patients. In all cases, the reexamination outcome was category 1 ("usefulness is confirmed").
    Conclusions: The reexamination process did not result in regulatory changes for any of the examined drugs. The Japan new-drug application (J-NDA) review and approval process, including implementation of the initial Japan product label, assures acceptable benefit/risk at the time of approval such that mandatory GDUI or SI studies for all products should be reconsidered. In the case of genuine scientific uncertainty to the extent that the benefit/risk of the product is not clear, a PMS is warranted.
    Language English
    Publishing date 2024-03-31
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2415165-8
    ISSN 1179-1993 ; 1178-2595
    ISSN (online) 1179-1993
    ISSN 1178-2595
    DOI 10.1007/s40290-024-00521-2
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  3. Article ; Online: Item Response Analyses of the Children's Depression Rating Scale-Revised Using Data from Clinical Studies.

    Yoshimatsu, Hiroki / Imaeda, Takayuki / Yoshiyama, Tamotsu / Higa, Shingo / Nomoto, Keisuke

    Journal of child and adolescent psychopharmacology

    2022  Volume 32, Issue 4, Page(s) 224–232

    Abstract: Objective: ...

    Abstract Objective:
    MeSH term(s) Adolescent ; Child ; Depression/drug therapy ; Depressive Disorder, Major/drug therapy ; Humans ; Psychiatric Status Rating Scales ; Psychometrics ; Reproducibility of Results
    Language English
    Publishing date 2022-05-11
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1055410-5
    ISSN 1557-8992 ; 1044-5463
    ISSN (online) 1557-8992
    ISSN 1044-5463
    DOI 10.1089/cap.2021.0141
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  4. Article: [Current and future views from pharmaceutical industry perspectives on development of antidepressants].

    Arano, Ichiro / Imaeda, Takayuki

    Nihon shinkei seishin yakurigaku zasshi = Japanese journal of psychopharmacology

    2011  Volume 31, Issue 4, Page(s) 181–186

    Abstract: It has recently become possible to conduct placebo-controlled clinical studies in Japan. However, worldwide, there has been much discussion of the problems in placebo-controlled studies, such as the fact that the increase in the placebo response in ... ...

    Abstract It has recently become possible to conduct placebo-controlled clinical studies in Japan. However, worldwide, there has been much discussion of the problems in placebo-controlled studies, such as the fact that the increase in the placebo response in clinical studies in depression increases the risk of failed studies and the number of patients that need to be enrolled. Japan has been participating in more multinational studies aimed at obtaining simultaneous worldwide approval. This paper discusses an overview of the development of antidepressants and examples of research that has been conducted on the placebo response, and describes the controversy regarding the designs of future studies as well as the issues involved in Japanese participation in multinational studies.
    MeSH term(s) Antidepressive Agents/administration & dosage ; Clinical Trials as Topic/methods ; Clinical Trials as Topic/trends ; Depression/drug therapy ; Drug Discovery/trends ; Drug Industry ; Forecasting ; Humans ; International Cooperation ; Placebos
    Chemical Substances Antidepressive Agents ; Placebos
    Language Japanese
    Publishing date 2011-08
    Publishing country Japan
    Document type English Abstract ; Journal Article ; Review
    ZDB-ID 1285665-4
    ISSN 1340-2544
    ISSN 1340-2544
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  5. Article: Factors impacting the efficacy of venlafaxine extended release 75-225 mg/day in patients with major depressive disorder: exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study in Japan.

    Watanabe, Yoshinori / Asami, Yuko / Hirano, Yoko / Kuribayashi, Kazuhiko / Itamura, Rio / Imaeda, Takayuki

    Neuropsychiatric disease and treatment

    2018  Volume 14, Page(s) 1261–1272

    Abstract: Purpose: To explore the potential factors impacting the efficacy of venlafaxine extended release (ER) and treatment differences between 75 mg/day and 75-225 mg/day dose in patients with major depressive disorder (MDD).: Methods: We performed ... ...

    Abstract Purpose: To explore the potential factors impacting the efficacy of venlafaxine extended release (ER) and treatment differences between 75 mg/day and 75-225 mg/day dose in patients with major depressive disorder (MDD).
    Methods: We performed exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study conducted in Japan. A total of 538 outpatients aged 20 years or older with a primary diagnosis of MDD who experienced single or recurrent episodes were randomized into three groups: fixed-dose, flexible-dose, or placebo. Venlafaxine ER was initiated at 37.5 mg/day and titrated to 75 mg/day for both fixed-dose and flexible-dose group, and to 225 mg/day for flexible-dose group (if well tolerated). Efficacy endpoints were changes from baseline at Week 8 using the Hamilton Rating Scale for Depression-17 items (HAM-D
    Results: Venlafaxine ER improved symptoms of MDD compared with placebo in most subgroups. The subgroup with a long duration of MDD (>22 months) consistently showed greater treatment benefits in the flexible-dose group than in the fixed-dose group.
    Conclusion: These results suggest that a greater treatment response to venlafaxine ER (up to 225 mg/day) can be seen in patients with a longer duration of MDD. Further investigations are needed to identify additional factors impacting the efficacy of venlafaxine ER.
    Language English
    Publishing date 2018-05-16
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2186503-6
    ISSN 1178-2021 ; 1176-6328
    ISSN (online) 1178-2021
    ISSN 1176-6328
    DOI 10.2147/NDT.S146428
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  6. Article ; Online: A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan.

    Higuchi, Teruhiko / Kamijima, Kunitoshi / Nakagome, Kazuyuki / Itamura, Rio / Asami, Yuko / Kuribayashi, Kazuhiko / Imaeda, Takayuki

    International clinical psychopharmacology

    2016  Volume 31, Issue 1, Page(s) 8–19

    Abstract: The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) ...

    Abstract The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75-225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery-Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (-10.76; P=0.031), but not in the flexible-dose (-10.37; P=0.106) group compared with placebo (-9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan.
    MeSH term(s) Adult ; Antidepressive Agents, Second-Generation/administration & dosage ; Antidepressive Agents, Second-Generation/adverse effects ; Antidepressive Agents, Second-Generation/therapeutic use ; Delayed-Action Preparations ; Depressive Disorder, Major/drug therapy ; Depressive Disorder, Major/psychology ; Double-Blind Method ; Female ; Humans ; Japan ; Male ; Middle Aged ; Outpatients ; Psychiatric Status Rating Scales ; Self-Injurious Behavior/psychology ; Suicidal Ideation ; Treatment Outcome ; Venlafaxine Hydrochloride/administration & dosage ; Venlafaxine Hydrochloride/adverse effects ; Venlafaxine Hydrochloride/therapeutic use
    Chemical Substances Antidepressive Agents, Second-Generation ; Delayed-Action Preparations ; Venlafaxine Hydrochloride (7D7RX5A8MO)
    Language English
    Publishing date 2016-01
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 632837-4
    ISSN 1473-5857 ; 0268-1315
    ISSN (online) 1473-5857
    ISSN 0268-1315
    DOI 10.1097/YIC.0000000000000105
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  7. Article: [Pharmacological, pharmacokinetic, and clinical profile of sertraline hydrochloride (J ZOLOFT)].

    Harada, Yoshimitsu / Kohara, Norihito / Imaeda, Takayuki

    Nihon yakurigaku zasshi. Folia pharmacologica Japonica

    2007  Volume 128, Issue 6, Page(s) 417–424

    MeSH term(s) Animals ; Antidepressive Agents ; Depressive Disorder/drug therapy ; Humans ; Panic Disorder/drug therapy ; Randomized Controlled Trials as Topic ; Serotonin Uptake Inhibitors ; Sertraline/pharmacokinetics ; Sertraline/pharmacology ; Sertraline/therapeutic use ; Tablets
    Chemical Substances Antidepressive Agents ; Serotonin Uptake Inhibitors ; Tablets ; Sertraline (QUC7NX6WMB)
    Language Japanese
    Publishing date 2007-01-01
    Publishing country Japan
    Document type Journal Article ; Review
    ZDB-ID 1097532-9
    ISSN 1347-8397 ; 0015-5691
    ISSN (online) 1347-8397
    ISSN 0015-5691
    DOI 10.1254/fpj.128.417
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