Trial · NCT01354353
A Study of Safety and Tolerability in Subjects With Schizophrenia
NCT01354353, Phase 1, Completed, Denovo Biopharma LLC; results first posted 2021-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Safety and Tolerability in Subjects With Schizophrenia. Trials, record NCT01354353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01354353
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Safety and Tolerability in Subjects With Schizophrenia
- NCT number
- NCT01354353
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 75 participants, actual
- Lead sponsor
- Denovo Biopharma LLC
- Conditions
- Schizophrenia
- Interventions
- LY2140023, Aripiprazole
- First posted
- 2011-05-16
- Last updated
- 2022-09-14
- Results first posted
- 2021-09-14
- Limitations and caveats
- No analyses were performed and results were not calculated for Part B of this study because the study was stopped prior to Part B being initiated.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | Baseline up to Day 21 for Part A | Participants with at least 1 postdose (Day 10 through the end of study visit \[Day 21\]) treatment emergent adverse event (TEAE) were counted by dose cohort. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Secondary | Part A: Pharmacokinetics, Maximum Concentration (Cmax) | Pre-dose and post-dose on Day 10 and Day 16 | |
| Secondary | Part B: Pharmacokinetics, Maximum Concentration (Cmax) | Pre-dose and post-dose on Days 12, 15, 18, 21, and 24 | Part B (dose titration as defined in Part B of study) was not conducted because the objective of the study was met in part A.; therefore, no data are available for analysis of this secondary outcome |
| Secondary | Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC) | Pre-dose and post-dose on Day 10 and Day 16 | The Day 10 parameter is area under the concentration versus time curve from time zero to infinity (AUC\[0-inf\]) post-single dose of LY2140023. The Day 16 parameter is area under the concentration versus time curve in a dosing interval (AUC\[0-tau\]) post-repeated daily doses of LY2140023. |
| Secondary | Part B: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC) | Pre-dose and post-dose on Days 12, 15, 18, 21, and 24 | Part B of this study was not conducted; therefore, no data are available for analysis. |
| Secondary | Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S) | Baseline through Day 17 for Part A | Clinical Global Impression- Severity Scale (CGI-S) measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The classification includes 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, and 7 = Among the most extremely ill patients. Increases or higher scores indicate increasing severity (=worse outcome) Only incidences of selected shifts of increasing severity (an increase in numbers on a scale) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis. |
| Secondary | Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS) | Baseline through Day 17 for Part A | Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a participant's general psychopathological symptoms. Item scores ranged from 0 (not assessed) to 7 (extremely severe). Total Scores ranged from 0 to 126. Increases or higher scores indicate a worsening of symptoms. Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the 18-symptom construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis. |
| Secondary | Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS) | Baseline through Day 17 for Part A | The Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Increases or higher scores indicate a worsening of symptoms. The classification includes 0 = None, 1 = Minimal, may be extreme normal, 2 = Mild, 3 = Moderate, and 4 - Severe. Only incidences of selected shifts of worsening severity (an increase in numbers on a scale within the 10-item construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis. |
| Secondary | Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS) | Baseline through Day 17 for Part A | Simpson-Angus Scale (SAS) is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. The scale 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 items. Increases or higher scores indicate a worsening of impairment. Only incidences of selected shifts of increasing impairment (an increase in numbers on a scale within the 10-symptom construct) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis. |
| Secondary | Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS) | Baseline through Day 17 for Part A | Barnes Akathisia Rating Scale (BAS) evaluates observable, restless movements of drug-induced akathisia associated with use of antipsychotic medications, includes objective (1-item) and subjective component (2-items, awareness of movement and distress related to movement) plus Global Clinical Assessment for overall disorder. Components were rated on a 4-point scale for the objective (0 = normal and 3 = constantly restless) and subjective items ((0 = absence of inner restlessness and 3 = awareness of intense compulsion to move for one item; and 0 = no distress and 3 = severe for the other item) and scored on a 6-point scale for the Global Clinical Assessment (0 = absent and 5 = severe). Increases or higher scores indicate a worsening of symptoms. Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the components) were reported for participants. Part B of this study was not conducted; therefore, no data are available for analysis. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | Baseline up to Day 21 for Part A | Participants who were assigned to treatment and were either dosed or discontinued prior to dosing. | participants | NUMBER |
| SECONDARY | Part A: Pharmacokinetics, Maximum Concentration (Cmax) | Pre-dose and post-dose on Day 10 and Day 16 | Participants who received at least one dose of LY2140023 with evaluable Cmax data. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part B: Pharmacokinetics, Maximum Concentration (Cmax) | Pre-dose and post-dose on Days 12, 15, 18, 21, and 24 | Zero participants were analyzed. | ||
| SECONDARY | Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC) | Pre-dose and post-dose on Day 10 and Day 16 | Participants who received at least one dose of LY2140023 with evaluable AUC data. | nanograms*hours/milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part B: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC) | Pre-dose and post-dose on Days 12, 15, 18, 21, and 24 | Zero participants were analyzed. | ||
| SECONDARY | Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S) | Baseline through Day 17 for Part A | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Clinical Global Impression- Severity Scale data. | percentage of participants with shifts | NUMBER |
| SECONDARY | Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS) | Baseline through Day 17 for Part A | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Brief Psychiatric Rating Scale data. | Percentage of participants with shifts | NUMBER |
| SECONDARY | Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS) | Baseline through Day 17 for Part A | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Abnormal Involuntary Movement Scale data. | Percentage of participants with shifts | NUMBER |
| SECONDARY | Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS) | Baseline through Day 17 for Part A | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Simpson-Angus Scale data. | Percentage of participants with shifts | NUMBER |
| SECONDARY | Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS) | Baseline through Day 17 for Part A | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Barnes Akathisia Scale data. | Percentage of participants with shifts | NUMBER |
Source ClinicalTrials.gov
Results by group146
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | Aripiprazole | Days 10-16 | 5 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | 160 mg LY2140023 | Days 10-16 | 6 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | 240 mg LY2140023 | Days 10-16 | 9 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | 320 mg LY2140023 | Days 10-16 | 11 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | 400 mg LY2140023 | Days 10-16 | 11 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | 480 mg LY2140023 | Days 10-16 | 11 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | Aripiprazole | Follow-up (Days 17-20) | 4 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | 160 mg LY2140023 | Follow-up (Days 17-20) | 2 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | 240 mg LY2140023 | Follow-up (Days 17-20) | 2 | participants | |
| Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) | 320 mg LY2140023 | Follow-up (Days 17-20) | 2 | participants |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aripiprazole | 16 | |
| Overall Study | STARTED | 160 mg LY2140023 | 12 | |
| Overall Study | STARTED | 240 mg LY2140023 | 11 | |
| Overall Study | STARTED | 320 mg LY2140023 | 12 | |
| Overall Study | STARTED | 400 mg LY2140023 | 12 | |
| Overall Study | STARTED | 480 mg LY2140023 | 12 | |
| Overall Study | Received at Least One Dose of Study Drug | Aripiprazole | 16 | |
| Overall Study | Received at Least One Dose of Study Drug | 160 mg LY2140023 | 11 | |
| Overall Study | Received at Least One Dose of Study Drug | 240 mg LY2140023 | 10 | |
| Overall Study | Received at Least One Dose of Study Drug | 320 mg LY2140023 | 11 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events420
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 | Palpitations | Cardiac disorders | Aripiprazole | 0 | 16 | 0 |
| other | Palpitations | Cardiac disorders | 160 mg LY2140023 | 1 | 11 | 1 |
| other | Palpitations | Cardiac disorders | 240 mg LY2140023 | 0 | 10 | 0 |
| other | Palpitations | Cardiac disorders | 320 mg LY2140023 | 0 | 11 | 0 |
| other | Palpitations | Cardiac disorders | 400 mg LY2140023 | 0 | 11 | 0 |
| other | Palpitations | Cardiac disorders | 480 mg LY2140023 | 0 | 11 | 0 |
| other | Tachycardia | Cardiac disorders | Aripiprazole | 0 | 16 | 0 |
| other | Tachycardia | Cardiac disorders | 160 mg LY2140023 | 0 | 11 | 0 |
| other | Tachycardia | Cardiac disorders | 240 mg LY2140023 | 0 | 10 | 0 |
| other | Tachycardia | Cardiac disorders | 320 mg LY2140023 | 0 | 11 | 0 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aripiprazole | ||
| Total, all-cause mortality | 160 mg LY2140023 | ||
| Total, all-cause mortality | 240 mg LY2140023 | ||
| Total, all-cause mortality | 320 mg LY2140023 | ||
| Total, all-cause mortality | 400 mg LY2140023 | ||
| Total, all-cause mortality | 480 mg LY2140023 | ||
| Total, other adverse events | Aripiprazole | 8 | 16 |
| Total, other adverse events | 160 mg LY2140023 | 7 | 11 |
| Total, other adverse events | 240 mg LY2140023 | 9 | 10 |
| Total, other adverse events | 320 mg LY2140023 | 11 | 11 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 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.
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/NCT01354353
GET https://conductscience.org/api/trials/v1/NCT01354353/results?page=2