Phase 2
Completed N=261
A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
Source: ClinicalTrials.gov NCT00845026 ↗Enrolled (actual)
261
Serious AEs
13.0%
Results posted
Sep 2022
Primary outcomePrimary: Time to Discontinuation Due to Adverse Event (AE) — 93.02; 116.86 days — p=0.184
Summary
The primary objective of this study was to assess time to discontinuation due to lack of tolerability among patients with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, versus those on atypical antipsychotic standard-of-care (SOC) treatment. Lack of tolerability was defined as discontinuation due to adverse events (AEs).
Patients who completed the active treatment phase were eligible to continue to an optional 28 weeks of treatment extension phase. This extension phase assessed key safety and efficacy measures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Discontinuation Due to Adverse Event (AE) |
93.02; 116.86 | 0.184 |
| SECONDARY Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs) |
11; 8; 74; 77; 18; 33 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs) |
3; 4 | — |
| SECONDARY Number of Participants With Treatment-Emergent Change in Neurological Examination |
16; 23; 17; 12; 9; 6 | — |
| SECONDARY Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint |
2.49; 0.87; 5.57; 1.10; 2.84; 3.47 | — |
| SECONDARY Change From Baseline in Weight at 52 Weeks Endpoint |
-4.76; 3.88 | — |
| SECONDARY Change From Baseline in Pulse Rate at 52 Weeks Endpoint |
-1.62; -2.44; -2.16; -2.41 | — |
| SECONDARY Number of Participants With Potentially Clinical Significant Change in Fasting Glucose Level |
8; 13 | — |
| SECONDARY Number of Participants With Potentially Clinical Significant Change in Lipids Level |
3; 6; 0; 0; 16; 23 | — |
| SECONDARY Number of Participants With Suicidal Behaviors and Ideations Baseline Through 52 Weeks |
8; 16; 0; 2 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at 52 Weeks Endpoint |
-4.54; -21.47 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at 52 Weeks Endpoint |
-0.27; -0.81 | — |
| SECONDARY Change From Baseline in 16-Item Negative Symptoms Assessment (NSA-16) Total Score at 52 Weeks Endpoint |
-2.86; -7.81 | — |
| SECONDARY Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB): Overall Composite T-Score at 52 Weeks Endpoint |
5.29; 8.19 | — |
| SECONDARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 52 Weeks Endpoint |
2.72; -2.82 | — |
| SECONDARY Change From Baseline in University of California-San Diego (UCSD) Performance-Based Skills Assessment-B (UPSA-B) Total Score at 52 Weeks Endpoint |
11.82; 12.84 | — |
| SECONDARY Percentage of Participants With Response (Rate of Response) at 6 and 24 Weeks Endpoints |
35.0; 31.3; 26.7; 37.5 | — |
| SECONDARY Percentage of Participants With Remission (Rate of Remission) at Week 24 Endpoint |
15.0; 22.7 | — |
| SECONDARY Percentage of Participants With Relapse (Rate of Relapse) |
26.2; 16.8 | — |
| SECONDARY Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score at 52 Weeks Endpoint |
1.11; 4.15 | — |
| SECONDARY Change From Baseline in Personal and Social Performance (PSP) at 52 Weeks Endpoint |
6.47; 10.71 | — |
| SECONDARY Change From Baseline in EuroQoL Questionnaire-5 Dimension (EQ-5D) at 52 Weeks Endpoint |
4.83; 12.84; 0.03; 0.10 | — |
| SECONDARY Change From Baseline in Number of Psychiatric Visits at 24 Weeks Endpoint |
-2.60; -2.95 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Scale (BAS) Global Score at 52 Weeks Endpoint |
-0.06; -0.08 | — |
| SECONDARY Change From Baseline in Simpson-Angus Scale (SAS) Total Score at 52 Weeks Endpoint |
-0.87; -0.82 | — |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at 52 Weeks Endpoint |
0.13; -0.23 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of schizophrenia
- Patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
- Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
- The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
- Disease symptoms must meet a certain range as assessed by the clinician
- Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
- Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
- Patients must be able to understand the nature of the study and have given their informed consent
Exclusion Criteria
- Patients who are actively suicidal
- Patients who are pregnant or nursing
- Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
- Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
- Patients with Parkinson's disease, psychosis related to dementia or related disorders
- Patients with known Human Immunodeficiency Virus positive (HIV+) status
Data sourced from ClinicalTrials.gov (NCT00845026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.