Trial · NCT01328093
A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients
NCT01328093, Phase 3, Terminated, Denovo Biopharma LLC; results first posted 2022-09-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients. Trials, record NCT01328093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01328093
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients
- NCT number
- NCT01328093
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 678 participants, actual
- Lead sponsor
- Denovo Biopharma LLC
- Conditions
- Schizophrenia
- Interventions
- LY2140023, Aripiprazole
- First posted
- 2011-04-04
- Last updated
- 2022-09-07
- Results first posted
- 2022-09-07
- Limitations and caveats
The study was terminated early. 97% of participants had completed or discontinued from the DB Phase prior to termination. Outcome measure populations excluded data from a site that had significant GCP noncompliance issues (3 participants).
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 24 Weeks in Body Weight | Baseline, 24 weeks | Mixed model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigator, visit, prior olanzapine use, treatment-by-visit interaction and baseline-by-visit interaction. |
| Secondary | Percentage of Participants With Clinically Significant Weight Change | Baseline up to 24 weeks | Clinically significant change in body weight is defined as either an increase or decrease in weight of ≥7% from baseline. |
| Secondary | Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS) | Baseline, 24 weeks | The BAS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 Global Clinical Assessment of Akathisia is rated on a 6- point scale, with scores range from 0 (no symptoms) to 5 (increased severity of symptoms); Only Item 4 was analyzed and presented. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. |
| Secondary | Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS) | Baseline, 24 weeks | 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: 0 (complete absence of the condition) to 4 (presence of the condition in extreme form). The SAS 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 Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment by-visit-interaction and baseline-by-visit interaction. |
| Secondary | Change From Baseline up to 24 Weeks in Abnormal Involuntary Movement Scale (AIMS) | Baseline, 24 weeks | 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: 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 are yes/no questions regarding the dental condition of a participant. The AIMS 1-7 Total Score is the sum of Items 1 through 7 of the AIMS, and ranges from 0 to 28. Higher scores indicate greater severity of illness. Only AIMS 1-7 Total Score was analyzed and presented. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. |
| Secondary | Change From Baseline up to 24 Weeks in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores | Baseline, 24 weeks | The PANSS consists of 30 items and 3 subscales and is designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. 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, with scores range from 30 to 210. The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. |
| Secondary | Change From Baseline up to 24 Weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) Visual Analog Scale (VAS) Health State Score | Baseline, 24 weeks | The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument that contains 2 parts: a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. VAS health state scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. |
| Secondary | Schizophrenia Resource Utilization Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits | Baseline to 24 weeks | The S-RUM is a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, ER visits, and outpatient medical visits for a specified period of time. Item 1 asks about the number of ER or equivalent facility visits a participant had for psychiatric (psych) illness. Item 2 asks about the number of ER or equivalent facility visits a participant had for non-psychiatric (non-psych) illness or injury. Item 5 asks about the number of outpatient visits to other physicians (not psychiatrists or dentists). Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for pooled investigator, gender and treatment. |
| Secondary | Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist | Baseline to 24 weeks | The S-RUM is a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, emergency room (ER) visits, and outpatient medical visits for a specified period of time. Item 4 asks about the number of sessions with a psychiatrist a participant had. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for pooled investigator, gender and treatment. |
| Secondary | Change From Baseline up to 24 Weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-SF) Total Score | Baseline, 24 weeks | The SWN-SF measures subjective well-being of the participant for the previous 7 days. The 20-item scale covers 5 health domains (subscales; 4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Each of the 5 subscale scores range from 4 to 24. SWN-SF Total Scores range from 20 to 120. Higher scores indicate greater well-being. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 24 Weeks in Body Weight | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had baseline and at least one post-baseline weight measurement, excluding participants from the excluded study site. | kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Clinically Significant Weight Change | Baseline up to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline weight measurement, excluding participants from the excluded study site. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS) | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: 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, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS) | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: 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, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Abnormal Involuntary Movement Scale (AIMS) | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: 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, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PANSS measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) Visual Analog Scale (VAS) Health State Score | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline VAS health state measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Schizophrenia Resource Utilization Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits | Baseline to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug and had S-RUM assessment, excluding participants from the excluded study site. Last observation carried forward (LOCF) principle was used. | visits | LEAST_SQUARES_MEAN |
| SECONDARY | Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist | Baseline to 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug and had S-RUM assessment, excluding participants from the excluded study site. Last observation carried forward (LOCF) principle was used. | sessions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline up to 24 Weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-SF) Total Score | Baseline, 24 weeks | Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline SWN-SF Total Score measurement, excluding participants from the excluded study site. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 24 Weeks in Body Weight | LY2140023-DB | -2.8 | Standard Error 0.4 | kilograms (kg) | |
| Change From Baseline to 24 Weeks in Body Weight | Aripiprazole-DB | 0.4 | Standard Error 0.6 | kilograms (kg) | |
| Percentage of Participants With Clinically Significant Weight Change | LY2140023-DB | ≥7% Increase | 4.1 | percentage of participants | |
| Percentage of Participants With Clinically Significant Weight Change | Aripiprazole-DB | ≥7% Increase | 7.1 | percentage of participants | |
| Percentage of Participants With Clinically Significant Weight Change | LY2140023-DB | ≥7% Decrease | 13.1 | percentage of participants | |
| Percentage of Participants With Clinically Significant Weight Change | Aripiprazole-DB | ≥7% Decrease | 3.2 | percentage of participants | |
| Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS) | LY2140023-DB | 0.00 | Standard Error 0.03 | units on a scale | |
| Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS) | Aripiprazole-DB | -0.04 | Standard Error 0.04 | units on a scale | |
| Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS) | LY2140023-DB | -0.17 | Standard Error 0.06 | units on a scale | |
| Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS) | Aripiprazole-DB | -0.20 | Standard Error 0.08 | units on a scale |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Phase | STARTED | LY2140023-DB / LY2140023-OL | 516 | |
| Double-Blind Phase | STARTED | Aripiprazole-DB / LY2140023-OL | 162 | |
| Double-Blind Phase | Received at Least 1 Dose of Study Drug | LY2140023-DB / LY2140023-OL | 514 | |
| Double-Blind Phase | Received at Least 1 Dose of Study Drug | Aripiprazole-DB / LY2140023-OL | 161 | |
| Double-Blind Phase | Modified Intent-To-Treat (mITT) | LY2140023-DB / LY2140023-OL | 511 | |
| Double-Blind Phase | Modified Intent-To-Treat (mITT) | Aripiprazole-DB / LY2140023-OL | 161 | |
| Double-Blind Phase | COMPLETED | LY2140023-DB / LY2140023-OL | 231 | |
| Double-Blind Phase | COMPLETED | Aripiprazole-DB / LY2140023-OL | 84 | |
| Double-Blind Phase | NOT COMPLETED | LY2140023-DB / LY2140023-OL | 285 | |
| Double-Blind Phase | NOT COMPLETED | Aripiprazole-DB / LY2140023-OL | 78 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events285
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 | Left atrial dilatation | Cardiac disorders | LY2140023-DB | 1 | 511 | 1 |
| other | Left atrial dilatation | Cardiac disorders | Aripiprazole-DB | 0 | 161 | 0 |
| other | Left atrial dilatation | Cardiac disorders | LY2140023-OL | 3 | 270 | 3 |
| other | Abdominal discomfort | Gastrointestinal disorders | LY2140023-DB | 13 | 511 | 14 |
| other | Abdominal discomfort | Gastrointestinal disorders | Aripiprazole-DB | 2 | 161 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | LY2140023-OL | 3 | 270 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2140023-DB | 10 | 511 | 10 |
| other | Abdominal pain upper | Gastrointestinal disorders | Aripiprazole-DB | 2 | 161 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2140023-OL | 1 | 270 | 1 |
| other | Constipation | Gastrointestinal disorders | LY2140023-DB | 14 | 511 | 15 |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2140023-DB | ||
| Total, all-cause mortality | Aripiprazole-DB | ||
| Total, all-cause mortality | LY2140023-OL | ||
| Total, other adverse events | LY2140023-DB | 358 | 511 |
| Total, other adverse events | Aripiprazole-DB | 107 | 161 |
| Total, other adverse events | LY2140023-OL | 112 | 270 |
| Total, serious adverse events | LY2140023-DB | 42 | 511 |
| Total, serious adverse events | Aripiprazole-DB | 5 | 161 |
| Total, serious adverse events | LY2140023-OL | 12 | 270 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24772351 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LY2140023-DB vs Aripiprazole-DB: Number of Participants With 30% or Greater Decrease in Positive and Negative Syndrome Scale (PANSS) Total Score |
Source 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.
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.
GET https://conductscience.org/api/trials/v1/NCT01328093
GET https://conductscience.org/api/trials/v1/NCT01328093/results?page=2