Trial · NCT00845026
A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
NCT00845026, Phase 2, Completed, Denovo Biopharma LLC; results first posted 2022-09-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients. Trials, record NCT00845026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00845026
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
- NCT number
- NCT00845026
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 261 participants, actual
- Lead sponsor
- Denovo Biopharma LLC
- Conditions
- Schizophrenia
- Interventions
- LY2140023, aripiprazole, olanzapine, risperidone
- First posted
- 2009-02-16
- Last updated
- 2022-11-08
- Results first posted
- 2022-09-01
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Discontinuation Due to Adverse Event (AE) | Baseline through 24 weeks | |
| Secondary | Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) | Baseline through 52 weeks | EEG scoring by a central neurologist is done by the following definitions: E0=Normal; E1(within normal)=fewer than 3 focal abnormalities or non-epileptiform abnormalities; E2(questionably epileptiform)=3-10 focal discharges and/or 1-10 multifocal or generalized discharges; E3=(clearly epileptiform)= Sharp/slow complex, runs of epileptiform abnormalities, greater than 10 total epileptiform discharges; and E4= seizure. Decreased= maximum (max) post-baseline (PB) EEG grading\< baseline EEG grading; Increased= max PB EEG grading\> baseline EEG grading; Same=no change from baseline to max PB result. |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs) | Baseline through 24 weeks | A potentially clinically significant QT interval (high) is defined as a value meeting the criteria of (\> 450 millisecond \[ms\]) at anytime during the active treatment phase, provided it does not meet the criteria at baseline. (analysis for Study Period III only) |
| Secondary | Number of Participants With Treatment-Emergent Change in Neurological Examination | Baseline through 52 weeks | An increase in score from baseline was considered a treatment-emergent change, unless stated otherwise. Tremor: 0 (absent) - 3 (interferes with motor function); Nystagmus: 0 (absent) - 3 (present on forward gaze); Reflexes: 0 (absent) - 4 (clonic) with normal being a score 2, decrease or increase in score was considered change. Finger-nose and gait tests: 0 (normal) - 1(abnormal); Romberg's sign: (0) absent - (1) present; Muscular strength: 0 (no contraction)-5 (full/normal resistance), decrease in score was considered change; Myoclonic jerks: 0 (absent) - 3 (frequent). |
| Secondary | Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint | Baseline, 52 weeks | Least Square (LS) Mean of change from baseline in BP is from a mixed model repeated measures (MMRM) model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction. |
| Secondary | Change From Baseline in Weight at 52 Weeks Endpoint | Baseline, 52 weeks | LS Mean of change from baseline in weight is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline weight and baseline-by-visit interaction. |
| Secondary | Change From Baseline in Pulse Rate at 52 Weeks Endpoint | Baseline, 52 weeks | LS Mean of change from baseline in pulse rate is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction. |
| Secondary | Number of Participants With Potentially Clinical Significant Change in Fasting Glucose Level | Baseline through 52 weeks | Treatment-emergent changes in lab results on fasting glucose were analyzed using the American Diabetes Association (ADA 2001) and National Cholesterol Education Program (NCEP ATP III) guidelines. Glucose Normal to High is \<100 milligram/deciliter (mg/dL) at baseline and ≥126mg/dL post-baseline. |
| Secondary | Number of Participants With Potentially Clinical Significant Change in Lipids Level | Baseline through 52 weeks | Treatment-emergent changes in lab results on lipids level were analyzed using the American Diabetes Association (ADA 2001) and National Cholesterol Education Program (NCEP ATP III) guidelines. Total cholesterol Normal to High is \<200 mg/dL at baseline and ≥240 mg/dL post-baseline. Low-density lipoprotein (LDL) cholesterol Normal to High is \<100 mg/dL at baseline and ≥160 mg/dL post-baseline. High-density lipoprotein (HDL) cholesterol Normal to Low is ≥40 mg/dL at baseline and \<40 mg/dL post-baseline. Triglycerides Normal to High is \<150 mg/dL at baseline and ≥200 mg/dL post-baseline. |
| Secondary | Number of Participants With Suicidal Behaviors and Ideations Baseline Through 52 Weeks | Baseline through 52 weeks | Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. There are no scores on a scale reported, rather, number of patients who reported "yes" as described above. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Discontinuation Due to Adverse Event (AE) | Baseline through 24 weeks | All randomized participants. | days | MEAN |
| SECONDARY | Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) | Baseline through 52 weeks | All randomized participants with both baseline and at least one post-baseline value. | participants | NUMBER |
| SECONDARY | Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs) | Baseline through 24 weeks | All randomized participants with normal baseline measurement and at least one post-baseline measurement. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Change in Neurological Examination | Baseline through 52 weeks | All randomized participants. | participants | NUMBER |
| SECONDARY | Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint | Baseline, 52 weeks | All randomized participants with both baseline and at least one non-missing post-baseline value. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weight at 52 Weeks Endpoint | Baseline, 52 weeks | All randomized participants with both baseline and at least one non-missing post-baseline value. | kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pulse Rate at 52 Weeks Endpoint | Baseline, 52 weeks | All randomized participants with both baseline and at least one non-missing post-baseline value. | beats per minute (bpm) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Potentially Clinical Significant Change in Fasting Glucose Level | Baseline through 52 weeks | All randomized participants with a normal baseline and at least one post-baseline result. | participants | NUMBER |
| SECONDARY | Number of Participants With Potentially Clinical Significant Change in Lipids Level | Baseline through 52 weeks | All randomized participants with a normal baseline and at least one post-baseline value. | participants | NUMBER |
| SECONDARY | Number of Participants With Suicidal Behaviors and Ideations Baseline Through 52 Weeks | Baseline through 52 weeks | All randomized participants with at least one post-baseline C-SSRS value. | participants | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Discontinuation Due to Adverse Event (AE) | LY2140023 | 93.02 | Standard Error 5.95 | days | |
| Time to Discontinuation Due to Adverse Event (AE) | Standard-of-Care (SOC) | 116.86 | Standard Error 5.73 | days | |
| Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) | LY2140023 | Decreased | 11 | participants | |
| Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) | Standard-of-Care (SOC) | Decreased | 8 | participants | |
| Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) | LY2140023 | Same | 74 | participants | |
| Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) | Standard-of-Care (SOC) | Same | 77 | participants | |
| Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) | LY2140023 | Increased | 18 | participants | |
| Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) | Standard-of-Care (SOC) | Increased | 33 | participants | |
| Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs) | LY2140023 | 3 | participants | ||
| Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs) | Standard-of-Care (SOC) | 4 | participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Period III | STARTED | LY2140023 | 130 | |
| Study Period III | STARTED | Standard-of-Care (SOC) | 131 | |
| Study Period III | COMPLETED | LY2140023 | 35 | |
| Study Period III | COMPLETED | Standard-of-Care (SOC) | 59 | |
| Study Period III | NOT COMPLETED | LY2140023 | 95 | |
| Study Period III | NOT COMPLETED | Standard-of-Care (SOC) | 72 | |
| Study Period IV | STARTED | LY2140023 | 28 | |
| Study Period IV | STARTED | Standard-of-Care (SOC) | 50 | |
| Study Period IV | COMPLETED | LY2140023 | 12 | |
| Study Period IV | COMPLETED | Standard-of-Care (SOC) | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events188
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 | Constipation | Gastrointestinal disorders | LY2140023 | 4 | 130 | 4 |
| other | Constipation | Gastrointestinal disorders | Olanzapine | 1 | 48 | 1 |
| other | Constipation | Gastrointestinal disorders | Aripiprazole | 1 | 48 | 2 |
| other | Constipation | Gastrointestinal disorders | Risperidone | 3 | 35 | 3 |
| other | Dry mouth | Gastrointestinal disorders | LY2140023 | 1 | 130 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Olanzapine | 3 | 48 | 3 |
| other | Dry mouth | Gastrointestinal disorders | Aripiprazole | 2 | 48 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Risperidone | 0 | 35 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | LY2140023 | 8 | 130 | 8 |
| other | Dyspepsia | Gastrointestinal disorders | Olanzapine | 1 | 48 | 1 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2140023 | ||
| Total, all-cause mortality | Olanzapine | ||
| Total, all-cause mortality | Aripiprazole | ||
| Total, all-cause mortality | Risperidone | ||
| Total, other adverse events | LY2140023 | 96 | 130 |
| Total, other adverse events | Olanzapine | 32 | 48 |
| Total, other adverse events | Aripiprazole | 40 | 48 |
| Total, other adverse events | Risperidone | 28 | 35 |
| Total, serious adverse events | LY2140023 | 22 | 130 |
| Total, serious adverse events | Olanzapine | 6 | 48 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LY2140023 vs Standard-of-Care (SOC): Number of Participants With Potentially Clinical Significant Change in Fasting Glucose Level | Trial comparisons |
| LY2140023 vs Standard-of-Care (SOC): Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs) | 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/NCT00845026
GET https://conductscience.org/api/trials/v1/NCT00845026/registered?page=2