Clinical trial NCT01009060: Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia
Official title: A Randomised Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Cognitive Enhancing Effect of GSK239512 in Stable Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: H3 Antagonist
Schizophrenia
double blind
Histamine
randomised
placebo controlled
Cognition
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia

Detailed description: This is a 7-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group design study in male and female subjects with schizophrenia who are stabilised on antipsychotic medication. Subjects will be randomised to receive either GSK239512 or placebo for 7 weeks. They will undergo weekly review of safety, tolerability and cognitive performance measures.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512
timeFrame: Baseline and up to Week 7
Secondary outcomes:
measure: 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
measure: Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7
timeFrame: Baseline and Week 7
measure: Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7
timeFrame: Baseline and Week 7
measure: Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7
timeFrame: Baseline and Week 7
measure: Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7
timeFrame: Baseline and Week 7
measure: Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7
timeFrame: Baseline and Week 7
measure: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Day 59
measure: Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings
timeFrame: Up to Day 59
measure: Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range
timeFrame: Up to Day 59
measure: Number of Par. With Heart Rate Measured Value Outside Clinical Concern Range
timeFrame: Up to Day 59
measure: Number of Par. With Abnormal Hematology Parameters Values at Any Time on Treatment
timeFrame: Up to Day 59
measure: Number of Par. With Abnormal Clinical Chemistry Parameters Values at Any Time On-treatment
timeFrame: Up to Day 59
measure: Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern
timeFrame: Up to Day 59
measure: 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
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: National City
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Catonsville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Jamaica Plain
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Mount Laurel
country: United States
facility: GSK Investigational Site
state: New Jersey
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Butner
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.