Last updated: 11/07/2018 05:42:43
Study to evaluate the efficacy and safety of GSK239512 in Schizophrenia
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised double-blind, placebo controlled, parallel group study to evaluate the cognitive enhancing effect of GSK239512 in stable patients with schizophrenia
Trial description: This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in composite score of CSSB following dosing with GSK239512
Timeframe: Baseline and up to Week 7
Secondary outcomes:
Change from Baseline in composite score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7
Timeframe: Baseline and Week 7
Change from Baseline in individual cognitive domain scores in CSSB at Week 7
Timeframe: Baseline and Week 7
Change from Baseline in individual cognitive domain scores in MCCB at Week 7
Timeframe: Baseline and Week 7
Change from Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7
Timeframe: Baseline and Week 7
Change from Baseline in schedule for assessment of negative symptoms (SANS) at Week 7
Timeframe: Baseline and Week 7
Change from Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7
Timeframe: Baseline and Week 7
Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Day 59
Number of par. with most severe on-treatment abnormal electrocardiogram (ECG) findings
Timeframe: Up to Day 59
Number of par. with systolic blood pressure (SBP) and diastolic blood pressure (DBP) readings outside clinical concern range
Timeframe: Up to Day 59
Number of par. with heart rate measured value outside clinical concern range
Timeframe: Up to Day 59
Number of par. with abnormal hematology parameters values at any time on treatment
Timeframe: Up to Day 59
Number of par. with abnormal clinical chemistry parameters values at any time on-treatment
Timeframe: Up to Day 59
Number of par. with abnormal urinalysis parameters values of potential clinical concern
Timeframe: Up to Day 59
Plasma concentrations of GSK239512 (Cmax) at steady state after repeat dosing on dose review visit at any time on-treatment
Timeframe: 15 minutes prior to start and 15 minutes after completion of CSSB at Week 1,2,3,4,5,6 and 7
Interventions:
Drug: GSK239512
Drug: Placebo
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2011-10-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Schizophrenia
Product
GSK239512
Collaborators
Not applicable
Study date(s)
December 2009 to August 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- 1. Clinical diagnosis of Schizophrenia
- 2. No acute exacerbation of symptoms requiring hospital admission or step up care in the previous six months.
- 1. Poses a significant homicidal or suicidal risk or evidence of previous homicidal or suicidal risk.
- 2. Co-morbid psychiatric or significant physical illness
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Clinical diagnosis of Schizophrenia 2. No acute exacerbation of symptoms requiring hospital admission or step up care in the previous six months. 3. Not on any symptomatic treatment for cognition
Exclusion criteria:
- 1. Poses a significant homicidal or suicidal risk or evidence of previous homicidal or suicidal risk. 2. Co-morbid psychiatric or significant physical illness 3. Alcohol or drug abuse or dependence.
Trial location(s)
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90073
Status
Study Complete
Location
GSK Investigational Site
Catonsville, Maryland, United States, 21228
Status
Study Complete
Location
GSK Investigational Site
Butner, North Carolina, United States, 27509
Status
Study Complete
Location
GSK Investigational Site
National City, California, United States, 91950
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95817
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46222
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90502
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92102
Status
Study Complete
Location
GSK Investigational Site
Jamaica Plain, Massachusetts, United States, 02130
Status
Study Complete
Location
GSK Investigational Site
Garden Grove, California, United States, 92845
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Study Complete
Location
GSK Investigational Site
Mount Laurel, New Jersey, United States, 08054
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-10-08
Actual study completion date
2011-10-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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