Trial · NCT01009060

Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia

NCT01009060, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-09-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia. Trials, record NCT01009060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01009060

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia
NCT number: NCT01009060
Status: Completed
Phases: Phase 2
Enrollment: 50 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Schizophrenia
Interventions: GSK239512, Placebo
First posted: 2009-11-06
Last updated: 2017-11-08
Results first posted: 2017-09-27

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	Baseline and up to Week 7	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.
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	Baseline and Week 7	MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and \< 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.
Secondary	Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7	Baseline and Week 7	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.
Secondary	Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7	Baseline and Week 7	MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and \< 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.
Secondary	Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7	Baseline and Week 7	BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; lower score is 18 and highest score is 126. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.
Secondary	Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7	Baseline and Week 7	The SANS was a tool used to assess five symptom complexes to obtain clinical ratings of negative symptoms in par. with schizophrenia. Complexes include: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. Assessment was conducted on six-point scale (0=not at all to 5=severe) for a total scoring range of 0-120. Lower scores represent better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.
Secondary	Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7	Baseline and Week 7	The UPSA is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains- comprehension and planning, finance, communication, mobility and house management. When combined, measures functional capacity. The comprehension and planning ranges from 0 to 14, the finance ranges from 0 to 11, the communication ranges from 0 to 12, the mobility ranges from 0 to 9, and the house management ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was score at a given time post Baseline minus Baseline score
Secondary	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to Day 59	AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Secondary	Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings	Up to Day 59	Triplicate 12-lead ECGs were obtained at Baseline (screening visit). Single 12-lead ECGs were obtained at each subsequent time point during the study. Abnormal ECG findings were presented for the most severe on-treatment result.
Secondary	Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range	Up to Day 59	Blood pressure readings both systolic and diastolic were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the par. got discharged. Blood pressure was measured in both standing (Std) and supine (Sup) position. Data with only abnormal values were presented. For SBP the data of concern was \<90 or \>140 and increase from Baseline (IFB) \>=40; \<90 or \>140 and decrease from Baseline (DFB) \>=30. For DBP the data of concern was \<50 or \>90 and IFB \>=30; \<50 or \>90 and DFB \>=20.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	Baseline and up to Week 7	ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.	Scores on a scale	LEAST_SQUARES_MEAN
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	Baseline and Week 7	ITT Population. Only those participants available at the indicated time point were analyzed.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7	Baseline and Week 7	ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7	Baseline and Week 7	ITT Population. Only those participants at indicated time point were analyzed.	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7	Baseline and Week 7	ITT Population. Only those participants available at the indicated time point were analyzed.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7	Baseline and Week 7	ITT Population. Only those participants available at the indicated time point were analyzed.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7	Baseline and Week 7	ITT Population. Only those participants available at the indicated time point were analyzed.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to Day 59	Safety Population consisted of all randomized par. who took at least one dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings	Up to Day 59	Safety Population. Only those participants who showed most severe on-treatment abnormal ECG findings are presented.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range	Up to Day 59	Safety Population. Only those par. available at the specified time points were analyzed.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group110

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	Placebo	Week 1	0.065	Standard Error 0.0606	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	GSK239512	Week 1	0.016	Standard Error 0.1342	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	Placebo	Week 2	0.086	Standard Error 0.0814	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	GSK239512	Week 2	0.104	Standard Error 0.0682	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	Placebo	Week 3	0.076	Standard Error 0.0816	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	GSK239512	Week 3	-0.012	Standard Error 0.1139	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	Placebo	Week 4	0.157	Standard Error 0.0859	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	GSK239512	Week 4	0.068	Standard Error 0.0901	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	Placebo	Week 5	0.099	Standard Error 0.0675	Scores on a scale
Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512	GSK239512	Week 5	0.184	Standard Error 0.1057	Scores on a scale

1 to 10 of 110Source ClinicalTrials.gov

See all 110 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	25
Overall Study	STARTED	GSK239512	25
Overall Study	COMPLETED	Placebo	21
Overall Study	COMPLETED	GSK239512	20
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	GSK239512	5

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Placebo	4	25
other	Headache	Nervous system disorders	GSK239512	6	25
other	Somnolence	Nervous system disorders	Placebo	1	25
other	Somnolence	Nervous system disorders	GSK239512	3	25
other	Dizziness	Nervous system disorders	Placebo	0	25
other	Dizziness	Nervous system disorders	GSK239512	2	25
other	Middle insomnia	Psychiatric disorders	Placebo	2	25
other	Middle insomnia	Psychiatric disorders	GSK239512	3	25
other	Abnormal dreams	Psychiatric disorders	Placebo	2	25
other	Abnormal dreams	Psychiatric disorders	GSK239512	2	25

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	25
Total, all-cause mortality	GSK239512	0	25
Total, other adverse events	Placebo	11	25
Total, other adverse events	GSK239512	15	25
Total, serious adverse events	Placebo	1	25
Total, serious adverse events	GSK239512	0	25

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25728831	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
GSK239512 vs Placebo: Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings	Trial comparisons
GSK239512 vs Placebo: deaths from any cause	Trial comparisons
GSK239512 vs Placebo: Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern	Trial comparisons
GSK239512 vs Placebo: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Verbal Fluency	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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