UMIN試験ID | UMIN000006417 |
---|---|
受付番号 | R000007612 |
科学的試験名 | うつ病個別化治療アルゴリズムの構築を目的とする遺伝子多型、定量脳波を用いた無作為割付臨床比較試験 |
一般公開日(本登録希望日) | 2011/09/27 |
最終更新日 | 2023/10/07 10:10:08 |
日本語
うつ病個別化治療アルゴリズムの構築を目的とする遺伝子多型、定量脳波を用いた無作為割付臨床比較試験
英語
Investigation of biological and clinical predictor of antidepressant response for personalized medicine in depression ; a randomized controlled trial
日本語
うつ病個別化治療アルゴリズムの構築を目的とするRCT研究
英語
Genotype Utility Needed for Depression Antidepressant Medication (GUNDAM)
日本語
うつ病個別化治療アルゴリズムの構築を目的とする遺伝子多型、定量脳波を用いた無作為割付臨床比較試験
英語
Investigation of biological and clinical predictor of antidepressant response for personalized medicine in depression ; a randomized controlled trial
日本語
うつ病個別化治療アルゴリズムの構築を目的とするRCT研究
英語
Genotype Utility Needed for Depression Antidepressant Medication (GUNDAM)
日本/Japan |
日本語
うつ病
英語
Major depression
精神神経科学/Psychiatry |
悪性腫瘍以外/Others
はい/YES
日本語
治療選択肢が多様化している現在のうつ病治療において、患者背景、うつ病のサブタイプ、生物学的指標(遺伝子多型や脳波)に基づく各個人に適したうつ病の治療法、すなわち“うつ病個別化治療アルゴリズム”を作成する事を目的とする。
英語
Based on patient characteristics, subtype of depression and biological factor such as genetic factor and QEEG, we aimed to develop the personalized medicine and prescribed best therapeutic tool for each patient. That is, to establish algorithm for treatment of depression.
安全性・有効性/Safety,Efficacy
日本語
英語
日本語
うつ症状の改善(HAM-D)
英語
Improvement of depressive symptom assessed by HAM-D
日本語
副作用(UKU)
QIDS
NEO personality inventory
社会認知機能
英語
Adverse effect assessed by UKU
QIDS
NEO personality inventory
Social-cognitive function
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
オープン/Open -no one is blinded
実薬・標準治療対照/Active
はい/YES
いいえ/NO
封筒法/Numbered container method
3
治療・ケア/Treatment
医薬品/Medicine |
日本語
うつ病患者に無作為にミルタザピンもしくは選択的セロトニン再取り込み阻害薬(SSRI)を割り付ける
英語
Depressive patients are randomly assigned to either mirtazapine or
SSRIs.
日本語
治療4週後Non-response群は、無作為に補充療法を行う群と行わない群に振り分ける
英語
Non-responders after 4-week treatment are randomly assigned to either maintain the same treatment or augmentation.
日本語
治療8週後Non-remission群は、補充療法を行う
英語
Augmentation therapy are added to the subject who does not remit after 8-week treatment.
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
18 | 歳/years-old | 以上/<= |
75 | 歳/years-old | 以下/>= |
男女両方/Male and Female
日本語
現在の病相が未治療(4週以上抗うつ薬が未投与)であるDSM―IVの大うつ病性障害の診断基準を満たす(原則としてHAM-D21項目 14点以上)18歳以上75歳未満の患者
英語
Drug naive patient (between 18 and 75 years old) with depression defined by DSN-IV whose HAM-D score are at least 14 .
日本語
DSM-IVで大うつ病以外のI軸診断基準を満たすもの、てんかん、痙攣性疾患、脳器質性疾患、アルコール依存、薬物依存、甲状腺機能亢進症など重篤なホルモン異常、重篤な心・肝・腎機能障害または造血器障害、試験薬剤の成分に対し過敏症の既往歴を有する患者、試験薬剤投与前3ヵ月以内に電気ショック療法を受けた患者、妊婦,授乳婦または妊娠している可能性のある患者、試験期間中に妊娠を希望する患者、その他,担当医師が不適当とした患者
英語
Subjects with clinically significant unstable medical illness, pregnancy, a principal psychiatric diagnosis other than major depression, a history of substance abuse or dependence active within the previous 6 months, and electroconvulsive therapy within the previous 6 months were excluded.
300
日本語
名 | 正樹 |
ミドルネーム | |
姓 | 加藤 |
英語
名 | Masaki |
ミドルネーム | |
姓 | Kato |
日本語
関西医科大学
英語
Kansai Medical University
日本語
精神神経科
英語
Department of Neuropsychiatry
570-8506
日本語
大阪府守口市文園町10-15
英語
10-15 Fumizonocho Moriguchi, Osaka
69921001
pangaea1975@yahoo.co.jp
日本語
名 | 正樹 |
ミドルネーム | |
姓 | 加藤 |
英語
名 | Masaki |
ミドルネーム | |
姓 | Kato |
日本語
関西医科大学
英語
Kansai Medical University
日本語
精神神経科
英語
Department of Neuropsychiatry
570-8506
日本語
大阪府守口市文園町10-15
英語
10-15, Fumizono-cho, Moriguchi City, Osaka
69921001
pangaea1975@yahoo.co.jp
日本語
その他
英語
Kansai Medical University Department of Neuropsychiatry
日本語
関西医科大学精神神経科
日本語
日本語
英語
日本語
その他
英語
Self funding, Ministry for Scientific Research,SENSHIN Medical Research Foundation
日本語
自己調達、先進医薬研究振興財団, 文部科学省科学研究費
日本語
その他/Other
日本語
英語
日本語
英語
日本語
英語
日本語
関西医科大学医学倫理審査委員会
英語
Medical Ethics Review Committee, Kansai Medical University
日本語
大阪府守口市文園町10番15号
英語
10-15 Fumizonocho Moriguchi, Osaka
06-6992-1001
katom@takii.kmu.ac.jp
いいえ/NO
日本語
英語
日本語
英語
関西医科大学付属滝井病院精神神経科(大阪府)
2011 | 年 | 09 | 月 | 27 | 日 |
http://www.journalofpsychiatricresearch.com/article/S0022-3956(16)30826-3/fulltext
最終結果が公表されている/Published
http://www.journalofpsychiatricresearch.com/article/S0022-3956(16)30826-3/fulltext
154
日本語
Mirtazapine showed significantly faster improvement compared to SSRIs. Somnolence rate was higher in mirtazapine and nausea rate was higher in SSRIs. Combination therapy showed a more favorable time course than SSRIs monotherapy.
英語
Mirtazapine showed significantly faster improvement compared to SSRIs. Somnolence rate was higher in mirtazapine and nausea rate was higher in SSRIs. Combination therapy showed a more favorable time course than SSRIs monotherapy.
2023 | 年 | 10 | 月 | 07 | 日 |
日本語
英語
日本語
From September 2011 through December 2014, a total of 207 patients were screened, 154 were enrolled and 141 took at least one post baseline HAM-D assessment during the step I study. Out of 126 patients who completed step I, 58 patient failed to reach response and were randomly assigned again and 45 patients (mirtazapine; n=13, SSRIs; n=12 and combination; n=20) had at least one post 4-week HAM-D assessment during the step IIa. On the other hand, 68 patients (mirtazapine; n=30 and SSRIs; n=38) reached response during the step I study and 66 patients continued the same SSRIs/mirtazapine monotherapy for another 4 weeks in step IIb. The baseline clinical and sociodemographic characteristics of subjects are presented in table 1. The mean age was 47.2 years, 48.9% were female and 22.7% were unemployed. Participants had moderate-to-severe depression, as indicated by a mean HAM-D17 score of 20.7 points. Over one-third had recurrent depression. Duration of current MDD episode was 8 months, total duration of MDD was 3.9 years and age at first episode was 43 years.
英語
From September 2011 through December 2014, a total of 207 patients were screened, 154 were enrolled and 141 took at least one post baseline HAM-D assessment during the step I study. Out of 126 patients who completed step I, 58 patient failed to reach response and were randomly assigned again and 45 patients (mirtazapine; n=13, SSRIs; n=12 and combination; n=20) had at least one post 4-week HAM-D assessment during the step IIa. On the other hand, 68 patients (mirtazapine; n=30 and SSRIs; n=38) reached response during the step I study and 66 patients continued the same SSRIs/mirtazapine monotherapy for another 4 weeks in step IIb. The baseline clinical and sociodemographic characteristics of subjects are presented in table 1. The mean age was 47.2 years, 48.9% were female and 22.7% were unemployed. Participants had moderate-to-severe depression, as indicated by a mean HAM-D17 score of 20.7 points. Over one-third had recurrent depression. Duration of current MDD episode was 8 months, total duration of MDD was 3.9 years and age at first episode was 43 years.
日本語
Participants
The subjects included to the study were 20-75 years old outpatients, met the diagnosis of major depressive disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I Disorders (American Psychiatric Association, 1994), Japanese, scoring at least 14 in the 17-item Hamilton Rating Scale for Depression (HAM-D 17) (Hamilton, 1967) and had been free of psychotropic drugs for at least 14 days before entering into the study. Subjects with clinically significant unstable medical illness, pregnancy, a principal psychiatric diagnosis other than major depression, a history of substance abuse or dependence active within the previous 6 months, and electroconvulsive therapy within the previous 6 months were excluded. The diagnoses were assigned by 2 independent senior psychiatrists and confirmed by a third psychiatrist.
Protocol treatment
In step I study, participants were randomly assigned to treatment with one of two classes of antidepressant; mirtazapine or SSRIs (paroxetine or sertraline) in a 1:1 ratio (Figure 1). Mirtazapine was administered once daily at bedtime and paroxetine and sertraline was administered once daily after dinner. The initial dose was 15mg/day for mirtazapine, 10 mg/day for paroxetine and 25 mg/day for sertraline. The dose must be increased to 30 mg/day for mirtazapine, 20mg/day for paroxetine and 50mg/day for sertraline within 2weeks and could be increased up to 45mg/day for mirtazapine, 40mg/day for paroxetine and 100 mg/day for sertraline in 4 weeks (maximum dose approved in Japan).
In step II study, patients who reached response, defined as an at least 50% decrease or remission, defined as 7 or less in HAM-D 17 total score after 4 weeks medication, continued the same monotherapy (Step IIb) and patients who failed to reach response or remission after 4 weeks, were randomly assigned to continue mirtazapine/ SSRIs monotherapy or combine them (Step IIa). Additional antidepressant was increased to minimally-effective dose (mirtazapine 30mg/day, paroxetine 20mg/day and sertraline 50mg/day) and could be adjusted based on clinical symptoms.
Concomitant psychotropic drugs were not allowed, except a low dose of sleep aids at bedtime for both Steps I and II. The patients' adherence to the study medication was monitored by counting the returned tablets and the patients' reports of non-adherence.
英語
Participants
The subjects included to the study were 20-75 years old outpatients, met the diagnosis of major depressive disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I Disorders (American Psychiatric Association, 1994), Japanese, scoring at least 14 in the 17-item Hamilton Rating Scale for Depression (HAM-D 17) (Hamilton, 1967) and had been free of psychotropic drugs for at least 14 days before entering into the study. Subjects with clinically significant unstable medical illness, pregnancy, a principal psychiatric diagnosis other than major depression, a history of substance abuse or dependence active within the previous 6 months, and electroconvulsive therapy within the previous 6 months were excluded. The diagnoses were assigned by 2 independent senior psychiatrists and confirmed by a third psychiatrist.
Protocol treatment
In step I study, participants were randomly assigned to treatment with one of two classes of antidepressant; mirtazapine or SSRIs (paroxetine or sertraline) in a 1:1 ratio (Figure 1). Mirtazapine was administered once daily at bedtime and paroxetine and sertraline was administered once daily after dinner. The initial dose was 15mg/day for mirtazapine, 10 mg/day for paroxetine and 25 mg/day for sertraline. The dose must be increased to 30 mg/day for mirtazapine, 20mg/day for paroxetine and 50mg/day for sertraline within 2weeks and could be increased up to 45mg/day for mirtazapine, 40mg/day for paroxetine and 100 mg/day for sertraline in 4 weeks (maximum dose approved in Japan).
In step II study, patients who reached response, defined as an at least 50% decrease or remission, defined as 7 or less in HAM-D 17 total score after 4 weeks medication, continued the same monotherapy (Step IIb) and patients who failed to reach response or remission after 4 weeks, were randomly assigned to continue mirtazapine/ SSRIs monotherapy or combine them (Step IIa). Additional antidepressant was increased to minimally-effective dose (mirtazapine 30mg/day, paroxetine 20mg/day and sertraline 50mg/day) and could be adjusted based on clinical symptoms.
Concomitant psychotropic drugs were not allowed, except a low dose of sleep aids at bedtime for both Steps I and II. The patients' adherence to the study medication was monitored by counting the returned tablets and the patients' reports of non-adherence.
日本語
Rate of sleepiness/sedation was significantly higher in mirtazapine prescribed subject (40.3%) compared to SSRIs (18.1%). Logistic regression analysis showed that mirtazapine (p=0.004, OR=3.3 95%CI=1.5-7.6) and male sex (p<0.001, OR=4.6 95%CI=1.9-10.7) contributed significantly to the higher rate of this adverse evet. But no difference was observed for more than 2 points worsening in rate of sleepiness/sedation between treatment groups (MIR=7.5%, SSRIs= 2.8%). Rate of nausea/vomiting was not observed for mirtazapine and this was significantly lower (p<0.0001) than for SSRIs (19.4%). For SSRIs, the rate of 2 point worsening was 6.9%. Both the rate of accommodation disturbances and erectile dysfunction/dry vagina for mirtazapine group was 0% and lower than SSRIs group (6.9% and 5.6%, respectively), but this differences were not statistically significant. Rate of drop out by any reason and by adverse event were 18.2% (mirtazapine=22.1%, SSRIs=14.3%) and 13.0% (mirtazapine=15.1%, SSRIs=10.1%), respectively without significant difference between treatment groups. No significant difference was observed for any other adverse event.
英語
Rate of sleepiness/sedation was significantly higher in mirtazapine prescribed subject (40.3%) compared to SSRIs (18.1%). Logistic regression analysis showed that mirtazapine (p=0.004, OR=3.3 95%CI=1.5-7.6) and male sex (p<0.001, OR=4.6 95%CI=1.9-10.7) contributed significantly to the higher rate of this adverse evet. But no difference was observed for more than 2 points worsening in rate of sleepiness/sedation between treatment groups (MIR=7.5%, SSRIs= 2.8%). Rate of nausea/vomiting was not observed for mirtazapine and this was significantly lower (p<0.0001) than for SSRIs (19.4%). For SSRIs, the rate of 2 point worsening was 6.9%. Both the rate of accommodation disturbances and erectile dysfunction/dry vagina for mirtazapine group was 0% and lower than SSRIs group (6.9% and 5.6%, respectively), but this differences were not statistically significant. Rate of drop out by any reason and by adverse event were 18.2% (mirtazapine=22.1%, SSRIs=14.3%) and 13.0% (mirtazapine=15.1%, SSRIs=10.1%), respectively without significant difference between treatment groups. No significant difference was observed for any other adverse event.
日本語
Treatment outcome measure
All patients were evaluated at baseline and bi-weekly thereafter until the end of the study using the HAM-D 17. The primary efficacy outcome was change in HAM-D 17 total score from baseline to week 4 for step I and from week 4 to week 8 for step II study. Secondary efficacy outcomes were rate of remission, defined as HAMD17 score <7, at week 2, 4, 6 and 8 and also the rate of response defined as a 50% decrease in severity from baseline at week 2 and 4. The HAM-D assessment was performed by trained senior psychiatrists (M.K., S.S., H.B., K.N. and Y.T.).
Side effect and adverse event measure
All adverse events volunteered or observed during the study were recorded, together with their severity and duration. The use of the Udvalg for Kliniske Undersogelser (UKU) side effect rating scale at baseline and bi-weekly ensured systematic collection of adverse events data. Other safety measures included 12-lead ECG and clinical laboratory assessments (hematology and serum chemistry) at baseline, week 4 and week8.
英語
Treatment outcome measure
All patients were evaluated at baseline and bi-weekly thereafter until the end of the study using the HAM-D 17. The primary efficacy outcome was change in HAM-D 17 total score from baseline to week 4 for step I and from week 4 to week 8 for step II study. Secondary efficacy outcomes were rate of remission, defined as HAMD17 score <7, at week 2, 4, 6 and 8 and also the rate of response defined as a 50% decrease in severity from baseline at week 2 and 4. The HAM-D assessment was performed by trained senior psychiatrists (M.K., S.S., H.B., K.N. and Y.T.).
Side effect and adverse event measure
All adverse events volunteered or observed during the study were recorded, together with their severity and duration. The use of the Udvalg for Kliniske Undersogelser (UKU) side effect rating scale at baseline and bi-weekly ensured systematic collection of adverse events data. Other safety measures included 12-lead ECG and clinical laboratory assessments (hematology and serum chemistry) at baseline, week 4 and week8.
日本語
英語
日本語
英語
主たる結果の公表済み/Main results already published
2011 | 年 | 01 | 月 | 01 | 日 |
2011 | 年 | 02 | 月 | 03 | 日 |
2011 | 年 | 09 | 月 | 01 | 日 |
2015 | 年 | 04 | 月 | 30 | 日 |
日本語
英語
2011 | 年 | 09 | 月 | 27 | 日 |
2023 | 年 | 10 | 月 | 07 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000007612
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007612
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