Trial · NCT01307800

A Study of LY2140023 in Patients With Schizophrenia

NCT01307800, Phase 3, Terminated, Denovo Biopharma LLC; results first posted 2022-10-18

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of LY2140023 in Patients With Schizophrenia. Trials, record NCT01307800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01307800

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Trial

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

Title: A Study of LY2140023 in Patients With Schizophrenia
NCT number: NCT01307800
Status: Terminated
Phases: Phase 3
Enrollment: 567 participants, actual
Lead sponsor: Denovo Biopharma LLC
Conditions: Schizophrenia
Interventions: LY2140023, Placebo
First posted: 2011-03-03
Last updated: 2022-10-18
Results first posted: 2022-10-18
Limitations and caveats: An interim analysis for futility was planned and conducted, using a pre-defined threshold. Since probability of trial meeting primary efficacy objectives, given available interim data, was below pre-defined level, trial was stopped early.

Source ClinicalTrials.gov

Registered outcomes23

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score	Baseline, Week 6	The PANSS scale assessed participants (pts) for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Secondary	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in a Predefined Subpopulation of Schizophrenia Participants	Baseline, Week 6	The PANSS scale assessed participants for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, and gender, as well as the continuous fixed covariates of baseline score, and baseline score-by-visit interaction.
Secondary	Change From Baseline in the Personal and Social Performance (PSP) Score	Baseline, Week 6	The PSP scale was a 100-point, single item scale that assessed 4 domains of functioning (personal and social relationships, socially useful activities, self-care, and disturbing and aggressive behaviors). PSP scores ranged from 1 (risk of death) to 100 (excellent functioning) in all 4 domain areas. A higher score indicated a better health state. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Secondary	Change From Baseline in the Personal and Social Performance (PSP) Score in a Predefined Subpopulation	Baseline, Week 6	The PSP scale was a 100-point, single item scale that assessed 4 domains of functioning (personal and social relationships, socially useful activities, self-care, and disturbing and aggressive behaviors). PSP scores ranged from 1 (risk of death) to 100 (excellent functioning) in all 4 domain areas. A higher score indicated a better health state. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, and gender, as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Secondary	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in Females	Baseline, Week 6	The PANSS scale assessed participants for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Secondary	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Subscores	Baseline, Week 6	PANSS subscales included the positive, negative, and general psychopathology subscales. PANSS positive and negative subscales assessed participants for 7 symptoms (positive or negative) associated with schizophrenia. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). Scores for both subscales ranged from 7 to 49. PANSS general psychopathology subscale assessed participants for 16 items of general psychopathology associated with schizophrenia. Each item was rated from 1 (absence of symptom) to 7 (symptom extremely severe). General psychopathology scores ranged from 16 to 112. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Secondary	Percentage of Participants Who Are Responders	Baseline, Week 6	Response during the treatment period was defined as a ≥30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) total score. The PANSS scale assessed participants for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210.
Secondary	Time to Response	Baseline up to Week 6	Time to response is the number of days from randomization until a ≥30% decrease from lead-in baseline in Positive and Negative Syndrome Scale (PANSS) total score. Participants who did not have a response were censored. The PANSS scale assessed participants for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210.
Secondary	Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Scale	Baseline, Week 6	The CGI-S was a single item scale that measured severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Secondary	Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16) Total Score	Baseline, Week 6	The NSA-16 scale was used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale contained 16 items and each item was rated from 1 (normal behavior) to 6 (extreme, abnormal behavior). The sum of the 16 items was defined as the NSA-16 total score and ranged from 16 to 96. Higher scores indicated a greater severity of illness. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

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 Positive and Negative Syndrome Scale (PANSS) Total Score	Baseline, Week 6	Pts in efficacy-evaluable intent-to-treat (EE-ITT) population (received at least 1 dose of study drug and not placebo lead-in responders) who had baseline and at least 1 post-baseline PANSS total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responder had ≥25% PANSS total score improvement in lead-in period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in a Predefined Subpopulation of Schizophrenia Participants	Baseline, Week 6	EE-ITT participants (see Outcome Measure 1 for population definition) in the predefined subpopulation who had a baseline and at least 1 post-baseline PANSS total score. The predefined subpopulation excluded non-Hispanic whites (self-reported) who had A/A genotype at the serotonin 2A receptor (HTR2A) single nucleotide polymorphism (SNP), rs7330461.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Personal and Social Performance (PSP) Score	Baseline, Week 6	Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PSP score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Personal and Social Performance (PSP) Score in a Predefined Subpopulation	Baseline, Week 6	EE-ITT participants (see Outcome Measure 1 for population definition) in the predefined subpopulation who had a baseline and at least 1 post-baseline PSP score. The predefined subpopulation excluded non-Hispanic whites (self-reported) who had A/A genotype at the serotonin 2A receptor (HTR2A) single nucleotide polymorphism (SNP), rs7330461.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in Females	Baseline, Week 6	Female participants (pts) in EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had baseline and at least 1 post-baseline PANSS total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had ≥25% PANSS total score improvement in lead-in period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Subscores	Baseline, Week 6	Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS subscore. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Who Are Responders	Baseline, Week 6	Participants in the EE-ITT population (participants who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS total score. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period; Last observation carried forward (LOCF).	percentage of participants	NUMBER
SECONDARY	Time to Response	Baseline up to Week 6	Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS total score. Number of pts censored: 80 mg LY2140023, BID = 88 pts, 40 mg LY2140023, BID = 90 pts, 10 mg LY2140023, BID = 99 pts, and placebo = 189 pts.	days	MEDIAN
SECONDARY	Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Scale	Baseline, Week 6	Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline CGI-S score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16) Total Score	Baseline, Week 6	Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had baseline and at least 1 post-baseline NSA-16 total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had ≥25% PANSS total score improvement in the lead-in period.	units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group144

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 Positive and Negative Syndrome Scale (PANSS) Total Score	80 mg LY2140023, BID	-3.7	Standard Error 2.1	units on a scale
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score	40 mg LY2140023, BID	-4.8	Standard Error 2.3	units on a scale
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score	10 mg LY2140023, BID	-5.0	Standard Error 2.0	units on a scale
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score	Placebo	-7.8	Standard Error 1.6	units on a scale
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in a Predefined Subpopulation of Schizophrenia Participants	80 mg LY2140023, BID	-3.4	Standard Error 2.2	units on a scale
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in a Predefined Subpopulation of Schizophrenia Participants	40 mg LY2140023, BID	-4.3	Standard Error 2.2	units on a scale
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in a Predefined Subpopulation of Schizophrenia Participants	10 mg LY2140023, BID	-4.8	Standard Error 2.0	units on a scale
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in a Predefined Subpopulation of Schizophrenia Participants	Placebo	-7.7	Standard Error 1.5	units on a scale
Change From Baseline in the Personal and Social Performance (PSP) Score	80 mg LY2140023, BID	7.9	Standard Error 1.4	units on a scale
Change From Baseline in the Personal and Social Performance (PSP) Score	40 mg LY2140023, BID	9.6	Standard Error 1.6	units on a scale

1 to 10 of 144Source ClinicalTrials.gov

See all 144 results by group

Participant flow20

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

Period	Milestone	Group	Participants
Overall Study	STARTED	80 mg LY2140023, BID	111
Overall Study	STARTED	40 mg LY2140023, BID	110
Overall Study	STARTED	10 mg LY2140023, BID	118
Overall Study	STARTED	Placebo	228
Overall Study	Received Treatment (Rec'd Tx)	80 mg LY2140023, BID	111
Overall Study	Received Treatment (Rec'd Tx)	40 mg LY2140023, BID	110
Overall Study	Received Treatment (Rec'd Tx)	10 mg LY2140023, BID	118
Overall Study	Received Treatment (Rec'd Tx)	Placebo	228
Overall Study	Rec'd Tx, Not a Placebo (PL) Responder	80 mg LY2140023, BID	102
Overall Study	Rec'd Tx, Not a Placebo (PL) Responder	40 mg LY2140023, BID	103

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events184

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	80 mg LY2140023, BID	2	111	2
other	Abdominal discomfort	Gastrointestinal disorders	40 mg LY2140023, BID	3	110	3
other	Abdominal discomfort	Gastrointestinal disorders	10 mg LY2140023, BID	3	118	3
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	4	228	4
other	Abdominal pain upper	Gastrointestinal disorders	80 mg LY2140023, BID	2	111	2
other	Abdominal pain upper	Gastrointestinal disorders	40 mg LY2140023, BID	3	110	4
other	Abdominal pain upper	Gastrointestinal disorders	10 mg LY2140023, BID	2	118	2
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	2	228	2
other	Constipation	Gastrointestinal disorders	80 mg LY2140023, BID	3	111	3
other	Constipation	Gastrointestinal disorders	40 mg LY2140023, BID	8	110	8

1 to 10 of 184Source ClinicalTrials.gov

See all 184 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	80 mg LY2140023, BID
Total, all-cause mortality	40 mg LY2140023, BID
Total, all-cause mortality	10 mg LY2140023, BID
Total, all-cause mortality	Placebo
Total, other adverse events	80 mg LY2140023, BID	70	111
Total, other adverse events	40 mg LY2140023, BID	70	110
Total, other adverse events	10 mg LY2140023, BID	75	118
Total, other adverse events	Placebo	129	228
Total, serious adverse events	80 mg LY2140023, BID	4	111
Total, serious adverse events	40 mg LY2140023, BID	6	110

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25890643	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 comparisons0

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

None in this release.

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.

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