Dear All,

GVK BIO in collaboration with Quantitative Solutions (QS), have developed 
Schizophrenia Clinical Trial Outcome Database. The database captures summary 
level data for the clinical safety and efficacy outcomes from publicly 
available data sources (Journal publications, Clinical trial registries, 
Conference posters, Regulatory reviews, etc.).

The database includes clinical safety and efficacy information on both 
second-generation antipsychotics (SGAs) currently approved or in development 
for the first-line monotherapy treatment of schizophrenia and on 
anti-psychotics used for the second-line treatment (monotherapy or add-on) in 
treatment-resistant or refractory schizophrenia patients. Information on 
first-generation antipsychotics (FGAs) such as haloperidol are included if they 
were used as active controls.

To give a brief summary of the content:

 Parameter


Description


Format


Excel


Indications


Schizophrenia


#Trials/References


114/128


# Patients


28,955


# Rows of Data


13,708


Last Updated


Sept, 2010*


Compounds


risperidone, paliperidone, quetiapine, ziprasidone, asenapine, aripiprazole, 
olanzapine, chlorpromazine, haloperidol, sertindole, clozapine, iloperidone, 
remoxipride, zotepine, cariprazine, methotrimeprazine, zotepine, fluoxetine, 
sulpiride, estradiol, mirtazapine, fluvoxamine, fluphenazine,ginkgo biloba, 
dehydroepiandrosterone, celecoxib, perphenazine, lamotrigine, CX516, donepezil, 
LY2140023, selegiline, amisulpride, ritanserin, pregnenolone and lurasidone.


Key efficacy end points


PANSS, BPRS, BPRSd, CGI, GAF, SANS, NSA-16, Response, Relapse


Key safety end points


ESRS, SAS, AIMS, BARS, SWN, adverse event percentages, and treatment 
discontinuations/required medication

 *The first version 1.0 was released last September 2009, and the Database was 
updated in September 2010, version 2.0.

Key Advantages:

·         Models derived from Database can be used to characterize the 
probability distribution of clinical efficacy and tolerability as a function of 
various treatment and patient factors.

·         The database can help companies conduct comparative efficacy and 
safety analysis, link/scale biomarkers to clinical outcomes, predict/improve 
trial outcome, and develop product differentiation strategies.

·         The database is supported by customization and M&S consulting 
services provided by GVK Bio and QS, respectively,  to ensure maximum 
flexibility and benefits to our clients

·         Kindly revert back for any further details on the Database and its 
utility

Kindly revert back for any further details on the Database and its utility

Best regards,
Satish

Satish Patil
Manager, Sales & Marketing
GVK Biosciences Pvt. Ltd., S-1, Phase-1,
Technocrats Industrial Estate, Balanagar, Hyderabad - 500 037
Ë+91-9177991172 | ': 040-40212953 | *: 
[email protected]<mailto:[email protected]>








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