کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5844307 | 1561027 | 2016 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Efficacy and safety of an adjunctive mGlu2 receptor positive allosteric modulator to a SSRI/SNRI in anxious depression
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کلمات کلیدی
MMRMIDSCGI-ISNRIC-SSRSHDRSInventory of Depressive SymptomatologyDSM-IVmGluR2SPCDMDDPAMSTAR*D - STAR * DTEAE - teaerMajor depressive disorder - اختلال افسردگی عمدهAnxiety - اضطرابSequenced Treatment Alternatives to Relieve Depression - جایگزین درمان تداخلی برای کاهش افسردگیtreatment emergent adverse event - درمان عوارض جانبی ناگهانیDiagnostic and Statistical Manual of Mental Disorders, fourth edition - راهنمای تشخیصی و آماری اختلالات روانی، نسخه چهارمpositive allosteric modulator - مدولاتور آلوده کننده مثبتColumbia-Suicide Severity Rating Scale - مقیاس درجه بندی شدت در کلمبیا - خودکشیHamilton Depression Rating Scale - مقیاس رتبه بندی افسردگی همیلتونSelective serotonin reuptake inhibitor - مهار کننده بازجذب سروتونین انتخابیserotonin-norepinephrine reuptake inhibitor - مهار کننده بازجذب سروتونین-نوراپی نفرینSSRI - مهارکنندههای بازجذب سروتونینHAM - هام
موضوعات مرتبط
علوم زیستی و بیوفناوری
علم عصب شناسی
روانپزشکی بیولوژیکی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Efficacy and safety of an adjunctive mGlu2 receptor positive allosteric modulator to a SSRI/SNRI in anxious depression Efficacy and safety of an adjunctive mGlu2 receptor positive allosteric modulator to a SSRI/SNRI in anxious depression](/preview/png/5844307.png)
چکیده انگلیسی
This phase 2a, randomized, multicenter, double-blind, proof-of-concept study was designed to evaluate, efficacy, safety and tolerability of JNJ-40411813/ADX71149, a novel metabotropic glutamate 2 receptor positive allosteric modulator as an adjunctive treatment for major depressive disorder (MDD) with significant anxiety symptoms. Eligible patients (18-64 years) had a DSM-IV diagnosis of MDD, Hamilton Depression Rating Scale-17 (HDRS17) score of â¥Â 18, HDRS17 anxiety/somatization factor score of â¥Â 7, and an insufficient response to current treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor. The doubly-randomized, 8-week double-blind treatment phase was comprised of two 4-week periods, from which a combined test statistic was generated, with pre-determined weights assigned to each of the 2 treatment periods. Period 1: patients (n = 121) were randomly assigned (1:1) to JNJ-40411813 (n = 62; 50 mg to 150 mg b.i.d, flexibly dosed) or placebo (n = 59); Period 2: placebo-treated patients (n = 22) who continued to meet entry severity criteria were re-randomized (1:1) to JNJ-40411813 or placebo, while other patients underwent sham re-randomization and continued on their same treatment. Of 121 randomized patients, 100 patients (82.6%) were completers. No efficacy signal was detected on the primary endpoint, the 6-item Hamilton Anxiety Subscale (HAM-A6, p = 0.51). Efficacy signals (based on prespecified 1-sided p < 0.20) were evident on several secondary outcome measures of both depression (HDRS17 total score, 6-item subscale of HDRS17 assessing core depressive symptoms [HAM-D6], and Inventory of Depressive Symptomatology [IDS-C30]) and anxiety (HDRS17 anxiety/somatization factor, IDS-C30 anxiety subscale). Although well-tolerated, the results do not suggest efficacy for JNJ-40411813 as an adjunctive treatment for patients with MDD with significant anxious symptoms in the dose range studied.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Progress in Neuro-Psychopharmacology and Biological Psychiatry - Volume 67, 3 June 2016, Pages 66-73
Journal: Progress in Neuro-Psychopharmacology and Biological Psychiatry - Volume 67, 3 June 2016, Pages 66-73
نویسندگان
Justine M. Kent, Ella Daly, Iva Kezic, Rosanne Lane, Pilar Lim, Heidi De Smedt, Peter De Boer, Luc Van Nueten, Wayne C. Drevets, Marc Ceusters,