Phase 2
Completed N=50
Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia
Source: ClinicalTrials.gov NCT01009060 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Sep 2017
Primary outcomePrimary: Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512 — 0.065; 0.016; 0.086; 0.104 Scores on a scale — p=0.7239
Summary
This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512 |
0.065; 0.016; 0.086; 0.104; 0.076; -0.012 | 0.7239 |
| SECONDARY Change From Baseline in Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7 |
1.108; 0.371 | 0.6947 |
| SECONDARY Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7 |
0.541; 0.289; 0.067; 0.246; 0.021; 0.412 | 0.1399 |
| SECONDARY Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7 |
2.045; -1.979; -0.111; -2.351; 3.368; 1.330 | 0.0225 sig |
| SECONDARY Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7 |
-2.795; -3.819 | 0.4406 |
| SECONDARY Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7 |
-3.206; -5.082 | 0.5197 |
| SECONDARY Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7 |
2.926; 4.750 | 0.4637 |
| SECONDARY Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) |
16; 17; 1; 0 | — |
| SECONDARY Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings |
8; 10 | — |
| SECONDARY Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Par. With Heart Rate Measured Value Outside Clinical Concern Range |
1; 0; 1; 0 | — |
| SECONDARY Number of Par. With Abnormal Hematology Parameters Values at Any Time on Treatment |
8; 4; 1; 0; 1; 0 | — |
| SECONDARY Number of Par. With Abnormal Clinical Chemistry Parameters Values at Any Time On-treatment |
1; 3; 1; 1; 0; 3 | — |
| SECONDARY Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern |
0; 0 | — |
| SECONDARY Plasma Concentrations of GSK239512 (Cmax) at Steady State After Repeat Dosing on Dose Review Visit at Any Time On-treatment |
0.0250; 0.0496; 0.0790; 0.1775 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01009060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.