Navigation Links
Shire Reports Positive Signal Finding Study of Investigative Use of Vyvanse(R) (lisdexamfetamine dimesylate) Capsules as Adjunctive Treatment in Major Depressive Disorder
Date:10/29/2010

ith inadequate response to treatment in MDD."

Notes to editors

MDD Phase 2 Trial Design

This Phase 2 trial (SPD489-203) was a multicenter, randomized, double-blind parallel-group, placebo-controlled signal finding study designed to evaluate the safety and efficacy of Vyvanse in the treatment of adult patients aged 18-55 with Major Depressive Disorder (MDD) as an adjunctive therapy to anti-depressant therapy in patients experiencing residual symptoms of depression following treatment with LEXAPRO (escitalopram) monotherapy. The study enrolled approximately 246 patients at 15 study centers across the U.S. Of these, 239 subjects were treated with escitalopram monotherapy for up to 8 weeks (20 mg per day), 177 subjects were randomized (HAM-D17 greater than or equal to 4) and 129 of the 177 subjects met non-remission criteria (MADRS >10), among which 86 subjects achieved < 50% improvement in total MADRS score. These 129 non-remitting subjects were randomized in a double-blind design to adjunctive treatment with placebo or Vyvanse in addition to escitalopram. Blinded Vyvanse dosing was optimized over the range of 20 to 50 mg, based on clinical criteria. The primary efficacy analysis was the comparison of placebo and VYVANSE on the mean change in total MADRS score after 6 weeks of double-blind treatment. Regular safety assessments examining adverse events, vital signs, and electrocardiographic and laboratory parameters were also performed. Subjects were excluded from the trial if they had a history of ADHD diagnosis, ADHD symptoms, or treatment with ADHD medication. Subjects who were considered a suicide risk were also excluded.

About Major Depressive Disorder (MDD) and Inadequate Response in MDD

Major Depressive Disorder (MDD), also known as major depression, is a mental disorder that causes depressed mood, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor conc
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related biology technology :

1. Shire Announces Holding of 81% in Jerini AG and Publication of Offer Document
2. Change of Name to Shire plc
3. Shires New Product Portfolio Delivers Strong Quarterly Performance
4. Shire Successfully Settles Former TKT Shareholder Appraisal Rights Litigation
5. Shire plc: Change to Directors Details
6. Shire Receives FOSRENOL Paragraph IV Notice Letters from Barr Laboratories and Mylan
7. Shire Delivers Excellent Growth for the Year, With the new Product Portfolio Achieving Sales of $1 Billion
8. Shire to Enter European ADHD Market With the Acquisition of EQUASYM(R) IR and XL
9. Shire Announces Opening of Office in Japan
10. Shire Files Lawsuit Against Barr Laboratories for Infringement of FOSRENOL(R) (Lanthanum Carbonate) Patents
11. Shire Files Lawsuit Against Mylan for Infringement of FOSRENOL(R) (Lanthanum Carbonate) Patent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2015)... 2015 W. R. Grace & ... in Worms, Germany has received good manufacturing practice ... the International Pharmaceutical Excipient Council (IPEC) Foundation. ... its SYLOID® FP brand of pharmaceutical grade excipient ... the Curtis Bay, Maryland (USA) and Sorocaba, Brazil ...
(Date:5/21/2015)... As part of its philanthropic partnership with Banner ... funded a $3.25 million project to relocate and equip ... up-to-date features and technology. , The new pharmacy is ... members will begin moving from the current location to ... , The current pharmacy has been using a ...
(Date:5/21/2015)... (PRWEB) May 21, 2015 Veolia’s ... an exclusive North American distribution agreement with VWR ... system. , With more than 160 years of ... and services for laboratory and production facilities, has ... excellence and differentiated services to enable science. ...
(Date:5/20/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/x4b7kw/top_technologies ... Technologies in HW_Technical Insights" report to their offering. ... technology trends in the Health and Wellness sector and ... have an impact in the year 2015. The research ... 10 health and wellness technologies that are anticipated to ...
Breaking Biology Technology:Grace European Facility Receives GMP Excipient Certification for SYLOID® FP Silica Gel 2Sun Health Foundation Provides $3.25M to Expand, Relocate Banner Del E. Webb Medical Center Pharmacy 2Sun Health Foundation Provides $3.25M to Expand, Relocate Banner Del E. Webb Medical Center Pharmacy 3Veolia’s TECTA™ B16 Instrument for E. Coli Detection is Offered Exclusively Through VWR 2Top Technologies in the Health and Wellness Industry 2015 2
... VIEW, Calif., Jan. 26 Based on its ... & Sullivan recognizes ESBATech with the 2009 North ... Year Award for its work in developing antibody ... antibody fragment therapeutics addresses and overcomes many of ...
... (OTC Bulletin Board: PDAE) today announced that its Hereford ... under Chapter 11 of the United States Bankruptcy Code ... District of Texas. The company intends to sell its ... Section 363 sale process approved by the bankruptcy court. ...
... JOLLA, Calif., Jan. 23 Cordex Pharma, Inc., formerly known ... that it will host a scientific briefing on Thursday, January ... The keynote speaker will be Jonathan S. Stamler, MD, the ... a Professor of Medicine and of Biochemistry at Duke ...
Cached Biology Technology:Frost & Sullivan Recognizes ESBATech's Innovation in Developing Antibody Fragments for Biologic Therapeutics 2Frost & Sullivan Recognizes ESBATech's Innovation in Developing Antibody Fragments for Biologic Therapeutics 3Frost & Sullivan Recognizes ESBATech's Innovation in Developing Antibody Fragments for Biologic Therapeutics 4Panda Ethanol's Hereford, Texas Subsidiary Files Voluntary Chapter 11 2Panda Ethanol's Hereford, Texas Subsidiary Files Voluntary Chapter 11 3Cordex Pharma Presents 'New Frontiers in Cardiovascular Medicines' on January 29 2Cordex Pharma Presents 'New Frontiers in Cardiovascular Medicines' on January 29 3Cordex Pharma Presents 'New Frontiers in Cardiovascular Medicines' on January 29 4Cordex Pharma Presents 'New Frontiers in Cardiovascular Medicines' on January 29 5
(Date:5/20/2015)... DUBLIN , May 20, 2015 ... Markets ( http://www.researchandmarkets.com/research/h8t4x6/5year ) has announced the ... of the Global Iris Recognition Market" ... http://photos.prnewswire.com/prnh/20130307/600769) , ,This research service analyses ... across the government and commercial sectors, ...
(Date:5/18/2015)... Fingerprint Cards (FPC) has received an ... and FPC1035 from one if its module partners. Deliveries are ... 2015 and the sensors will be used by smartphone manufacturers ... 2015 hereby amount to 740 MSEK to date. In addition ... and a number of smaller orders not separately communicated amounting ...
(Date:5/11/2015)... N.Y. , May 11, 2015 Curemark ... announced the start of a new Phase III double ... of its novel formulation, CM-AT, on all children ages ... of its FDA Phase III double blinded clinical trial ... had low levels of the digestive enzyme chymotrypsin. This ...
Breaking Biology News(10 mins):Global Iris Recognition Market Report 2015 - 5-Year Opportunity Analysis 2Fingerprint Cards Receives Touch Fingerprint Sensor Order of SEK 230 Million and Raises Revenue Guidance for 2015 2Curemark, LLC, Launches New Phase III Trial in Expanded Population of Children with Autism 2
... PITTSBURGHCarnegie Mellon University researchers have found that within ... neurons that behave much like people in social networks. ... of highly active members who give and receive more ... Barth, associate professor of biological sciences at Carnegie Mellon ...
... 10, 2011 Cleveland Researchers have discovered a ... undergo testing for genetic mutations of the tumor suppressor ... including several types of cancers. The research has created ... Led by Charis Eng, M.D., Ph.D., Chair of ...
... (January 9, 2011) - While age-related vision loss of ... million patients today to 55 million by the year 2050, ... vision even restored using molecular medicine. ... at the 10th annual meeting and International Conference on Recent ...
Cached Biology News:Carnegie Mellon researchers identify 'Facebook neurons' 2Carnegie Mellon researchers identify 'Facebook neurons' 3Researchers create 'scoring system' for PTEN mutation testing 2Molecular medicine could avert predicted catastrophic vision loss in the aged 2Molecular medicine could avert predicted catastrophic vision loss in the aged 3
Viral CMV UL146/vCXC1 Biotinylated Affinity Purified PAb...
Request Info...
D-biotin *50 mM aqueous solution* Secondary Detection Biotin–Avidin Detection Reagents Other...
... strains are high-performance BL21 ... protein yield in T7 ... 1). Because the T7 ... more rapidly than E. ...
Biology Products: