Phase 2
N=167
A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01052103 ↗Enrolled (actual)
167
Serious AEs
7.3%
Results posted
Sep 2021
Primary outcome: Primary: Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16) — -2.7; -3.6 units on a scale — p=0.732
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2140023 (Drug); Placebo (Drug); Standard of Care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Denovo Biopharma LLC
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16) |
-2.7; -3.6 | 0.732 |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score |
-4.4; -6.6 | 0.846 |
| SECONDARY Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale |
-0.4; -0.3 | 0.201 |
| SECONDARY Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score |
3.2; 1.8 | 0.136 |
| SECONDARY Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score |
6.5; 4.9 | 0.739 |
| SECONDARY Change From Baseline in Barnes-Akathisia Scale (BAS) Global Score |
-0.1; 0.0 | 0.190 |
| SECONDARY Change From Baseline in Simpson Angus Scale (SAS) Total Score |
-0.2; -0.1 | 0.702 |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score |
0.0; 0.1 | 0.851 |
| SECONDARY Number of Participants With Incidence of Epileptiform Activity Outside of Normal Range in Electroencephalograms (EEGs) |
1; 0 | — |
| SECONDARY Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs) |
3; 1 | — |
| SECONDARY Percentage of Participants With a Worsening of Neurological Symptoms From Baseline to Endpoint on the Neurological Examination |
11.0; 12.2; 2.4; 2.4; 3.7; 4.9 | — |
| SECONDARY Change From Baseline in Standing Blood Pressure (BP) |
-2.0; -2.0; 1.4; -2.4 | 0.999 |
| SECONDARY Change From Baseline in Standing Pulse Rate |
-2.3; -1.8 | 0.818 |
| SECONDARY Change From Baseline in Weight |
-1.25; -0.81 | 0.571 |
| SECONDARY Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - General |
4; 5; 1; 3; 2; 0 | — |
| SECONDARY Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Cholesterol |
1; 0; 8; 7; 9; 7 | — |
| SECONDARY Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Triglycerides |
10; 7; 20; 13; 0; 0 | — |
| SECONDARY Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Glucose |
2; 8; 10; 5; 12; 13 | — |
| SECONDARY Percentage of Participants With Incidence of Potentially Clinically Significant Change of Columbia-Suicide Severity Rating Scale (C-SSRS) |
2.4; 4.9; 0.0; 1.2 | 0.682 |
| SECONDARY Change From Baseline to Endpoint in Personal and Social Performance (PSP) Scale |
8.9; 7.9 | 0.727 |
| SECONDARY Time to Discontinuation From the Study Due to Any Reason |
NA; NA | — |
| SECONDARY Schizophrenia Resource Use Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits |
0.6; 0.2; 0.2; 0.1; 0.7; 1.2 | — |
| SECONDARY Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist |
3.4; 1.5 | — |
| SECONDARY Change From Baseline to Endpoint in the EuroQol Questionnaire-5 Dimension (EQ-5D) Visual Analog Scale (VAS) Health State Score |
3.7; 5.4 | 0.305 |
| SECONDARY Change From Baseline to Endpoint in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-SF) Total Score |
3.9; 4.4 | 0.420 |
Summary
The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of schizophrenia
- Participants must have been receiving monotherapy treatment for at least 3 months prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole, olanzapine, risperidone, quetiapine)
- Disease symptoms must meet a certain range as assessed by the clinician
- Participants must have evidence of prominent negative symptoms of schizophrenia (for example blunted affect, emotional withdrawal, or motor retardation)
- Participants 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
- Participants must be able to understand the nature of the study and have given their informed consent
Exclusion Criteria
- Participants who are actively suicidal
- Participants who are pregnant or nursing
- Participants who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
- Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
- Participants with Parkinson's disease, psychosis related to dementia or related disorders
- Participants with known Human Immunodeficiency Virus positive (HIV+) status
Data sourced from ClinicalTrials.gov (NCT01052103). 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.