Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia
A Randomised Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Cognitive Enhancing Effect of GSK239512 in Stable Patients With Schizophrenia
1 other identifier
interventional
50
1 country
15
Brief Summary
This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 schizophrenia
Started Dec 2009
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2011
CompletedResults Posted
Study results publicly available
September 27, 2017
CompletedNovember 8, 2017
August 1, 2017
1.7 years
November 5, 2009
July 5, 2017
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512
The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.
Baseline and up to Week 7
Secondary Outcomes (14)
Change From Baseline in Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7
Baseline and Week 7
Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7
Baseline and Week 7
Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7
Baseline and Week 7
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7
Baseline and Week 7
Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7
Baseline and Week 7
- +9 more secondary outcomes
Study Arms (2)
GSK239512
EXPERIMENTALRepeat dose.
Placebo
PLACEBO COMPARATORRepeat dose. Placebo to match GSK239512
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Schizophrenia
- No acute exacerbation of symptoms requiring hospital admission or step up care in the previous six months.
- Not on any symptomatic treatment for cognition
You may not qualify if:
- Poses a significant homicidal or suicidal risk or evidence of previous homicidal or suicidal risk.
- Co-morbid psychiatric or significant physical illness
- Alcohol or drug abuse or dependence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Garden Grove, California, 92845, United States
GSK Investigational Site
Los Angeles, California, 90073, United States
GSK Investigational Site
National City, California, 91950, United States
GSK Investigational Site
Sacramento, California, 95817, United States
GSK Investigational Site
San Diego, California, 92102, United States
GSK Investigational Site
Torrance, California, 90502, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Indianapolis, Indiana, 46222, United States
GSK Investigational Site
Catonsville, Maryland, 21228, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
GSK Investigational Site
Jamaica Plain, Massachusetts, 02130, United States
GSK Investigational Site
Mount Laurel, New Jersey, 08054, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Butner, North Carolina, 27509, United States
Related Publications (1)
Jarskog LF, Lowy MT, Grove RA, Keefe RS, Horrigan JP, Ball MP, Breier A, Buchanan RW, Carter CS, Csernansky JG, Goff DC, Green MF, Kantrowitz JT, Keshavan MS, Laurelle M, Lieberman JA, Marder SR, Maruff P, McMahon RP, Seidman LJ, Peykamian MA. A Phase II study of a histamine H(3) receptor antagonist GSK239512 for cognitive impairment in stable schizophrenia subjects on antipsychotic therapy. Schizophr Res. 2015 May;164(1-3):136-42. doi: 10.1016/j.schres.2015.01.041. Epub 2015 Feb 24.
PMID: 25728831DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
December 1, 2009
Primary Completion
August 10, 2011
Study Completion
August 10, 2011
Last Updated
November 8, 2017
Results First Posted
September 27, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.