Trial · NCT01052103

A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

NCT01052103, Phase 2, Completed, Denovo Biopharma LLC; results first posted 2021-09-22

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms. Trials, record NCT01052103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01052103

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Trial

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

Title: A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms
NCT number: NCT01052103
Status: Completed
Phases: Phase 2
Enrollment: 167 participants, actual
Lead sponsor: Denovo Biopharma LLC
Conditions: Schizophrenia
Interventions: LY2140023, Placebo, Standard of Care
First posted: 2010-01-20
Last updated: 2022-09-07
Results first posted: 2021-09-22

Source ClinicalTrials.gov

Registered outcomes25

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16)	Baseline, randomization treatment Week 16	The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The total score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\visit, baseline NSA-16 total score, and baseline NSA-16 total score\visit.
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	Baseline, randomization treatment Week 16	The PANSS Scale consists of 30 items and is designed to measure the severity of psychopathology in schizophrenia. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS total score is the sum of the 30 items and has a score ranging from 30 to 210. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\visit, baseline PANSS total score, and baseline PANSS total score\visit.
Secondary	Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale	Baseline, randomization treatment Week 16	The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\visit, baseline CGI-S score, and baseline CGI-S score\visit.
Secondary	Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score	Baseline, randomization treatment Week 16	MCCB is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB overall composite T-score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the MCCB overall composite T-score. Higher scores indicate better cognition. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\visit, baseline MCCB overall composite T-score, and baseline MCCB overall composite T-score\visit.
Secondary	Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score	Baseline, randomization treatment Week 16	The UPSA-B is a performance-based assessment of improvement in functional capacity. Participants are asked to role-play tasks in 2 areas of functioning: communication and finances. Raw scores for the 2 subscales are converted into an UPSA-B Total Score (range = 0-100) with higher scores indicating a greater level of functional capacity. Scores of 75 or higher are associated with independent living. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\visit, baseline UPSA-B total score, and baseline UPSA-B total score\visit.
Secondary	Change From Baseline in Barnes-Akathisia Scale (BAS) Global Score	Baseline, randomization treatment Week 16	The BAS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global Clinical Assessment and is rated 0 to 5 (0 = absent, 5 = severe). The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\visit, baseline BAS global score, and baseline BAS global score\visit.
Secondary	Change From Baseline in Simpson Angus Scale (SAS) Total Score	Baseline, randomization treatment Week 16	The SAS is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. SAS consists of 10 items; each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the ten items, and ranges from 0 to 40. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\visit, baseline SAS total score, and baseline SAS total score\visit.
Secondary	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score	Baseline, randomization treatment Week 16	The AIMS is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 to 10 are rated on a 5- point scale, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of a subject. The AIMS 1-7 total score is the total of items 1 through 7 of the AIMS, and ranges from 0 to 28. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\visit, baseline AIMS 1-7 total score, and baseline AIMS 1-7 total score\visit.
Secondary	Number of Participants With Incidence of Epileptiform Activity Outside of Normal Range in Electroencephalograms (EEGs)	Baseline to randomization treatment Week 16	Incidence of epileptiform activity outside of normal range in EEGs is based on the changes from normal (E0) or within normal range (E1) at baseline to questionably epileptiform (E2) or clearly epileptiform (E3) or seizure (E4) post-baseline. E0 = Normal; E1 (within normal range) = fewer than 3 focal abnormalities or non-epileptiform abnormalities; E2 (questionably epileptiform) = 3 to 10 focal discharges and/or 1 to 10 multifocal or generalized discharges; E3 (clearly epileptiform) = Sharp/slow complex, runs of epileptiform abnormalities, greater than 10 total epileptiform discharges; and E4 = seizure.
Secondary	Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs)	Baseline to randomization treatment Week 16	QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using the Fridericia formula. A potentially clinically significant change in QTcF is defined as \>450 milliseconds (ms) for male and \>470 ms for female.

1 to 10 of 25Source ClinicalTrials.gov

See all 25 registered outcomes

Outcomes25

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 the 16-Item Negative Symptoms Assessment (NSA-16)	Baseline, randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline NSA-16 total score measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	Baseline, randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PANSS total score measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale	Baseline, randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline CGI-S measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score	Baseline, randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline MCCB overall composite T-score measurement.	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score	Baseline, randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline UPSA-B total score measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Barnes-Akathisia Scale (BAS) Global Score	Baseline, randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline BAS global score measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Simpson Angus Scale (SAS) Total Score	Baseline, randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline SAS total score measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score	Baseline, randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline AIMS 1-7 total score measurement.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Incidence of Epileptiform Activity Outside of Normal Range in Electroencephalograms (EEGs)	Baseline to randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline EEG measurement.	participants	NUMBER
SECONDARY	Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs)	Baseline to randomization treatment Week 16	All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline ECG QTcF measurement.	participants	NUMBER

1 to 10 of 25Source ClinicalTrials.gov

See all 25 outcomes

Results by group116

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

Outcome	Group	Value	Spread	Units
Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16)	LY2140023 + SOC	-2.7	Standard Error 1.2	units on a scale
Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16)	Placebo + SOC	-3.6	Standard Error 1.2	units on a scale
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	LY2140023 + SOC	-4.4	Standard Error 1.62	units on a scale
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	Placebo + SOC	-6.6	Standard Error 1.55	units on a scale
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale	LY2140023 + SOC	-0.4	Standard Error 0.1	units on a scale
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale	Placebo + SOC	-0.3	Standard Error 0.1	units on a scale
Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score	LY2140023 + SOC	3.2	Standard Error 1.0	T-scores
Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score	Placebo + SOC	1.8	Standard Error 1.0	T-scores
Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score	LY2140023 + SOC	6.5	Standard Error 1.9	units on a scale
Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score	Placebo + SOC	4.9	Standard Error 1.8	units on a scale

1 to 10 of 116Source ClinicalTrials.gov

See all 116 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	LY2140023 + SOC	84
Overall Study	STARTED	Placebo + SOC	83
Overall Study	Received at Least 1 Dose of Study Drug	LY2140023 + SOC	82
Overall Study	Received at Least 1 Dose of Study Drug	Placebo + SOC	82
Overall Study	COMPLETED	LY2140023 + SOC	50
Overall Study	COMPLETED	Placebo + SOC	60
Overall Study	NOT COMPLETED	LY2140023 + SOC	34
Overall Study	NOT COMPLETED	Placebo + SOC	23

Source ClinicalTrials.gov

Adverse events58

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	Events
other	Abdominal discomfort	Gastrointestinal disorders	LY2140023 + SOC	3	82	3
other	Abdominal discomfort	Gastrointestinal disorders	Placebo + SOC	0	82	0
other	Diarrhoea	Gastrointestinal disorders	LY2140023 + SOC	5	82	5
other	Diarrhoea	Gastrointestinal disorders	Placebo + SOC	2	82	3
other	Dry mouth	Gastrointestinal disorders	LY2140023 + SOC	2	82	2
other	Dry mouth	Gastrointestinal disorders	Placebo + SOC	9	82	9
other	Nausea	Gastrointestinal disorders	LY2140023 + SOC	11	82	12
other	Nausea	Gastrointestinal disorders	Placebo + SOC	4	82	4
other	Toothache	Gastrointestinal disorders	LY2140023 + SOC	1	82	1
other	Toothache	Gastrointestinal disorders	Placebo + SOC	3	82	3

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LY2140023 + SOC
Total, all-cause mortality	Placebo + SOC
Total, other adverse events	LY2140023 + SOC	54	82
Total, other adverse events	Placebo + SOC	51	82
Total, serious adverse events	LY2140023 + SOC	8	82
Total, serious adverse events	Placebo + SOC	4	82

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons3

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

Comparison	Source
LY2140023 + SOC vs Placebo + SOC: Number of Participants With Incidence of Epileptiform Activity Outside of Normal Range in Electroencephalograms (EEGs)	Trial comparisons
LY2140023 + SOC vs Placebo + SOC: Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs)	Trial comparisons
LY2140023 + SOC vs Placebo + SOC: serious adverse events	Trial comparisons

Tests0

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

None in this release.

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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