An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.
Study HBBM was a multicenter, randomized, double-blind, parallel, fixed-dose, Phase 2 study to assess the efficacy and safety of 2 dose levels of LY2140023 (80 mg BID or 40 mg BID) compared to placebo in patients with schizophrenia, with a risperidone treatment arm to ensure assay sensitivity in patients with schizophrenia. The primary objective of this study was to test the hypothesis that at least 1 dose level of LY2140023, given orally to patients with schizophrenia at 80 mg BID or 40 mg BID, would demonstrate significantly greater efficacy than placebo at Visit 9, as measured by the change from baseline in the PANSS total score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,134
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the Personal and Social Performance (PSP) score in a genetic subgroup of schizophrenia patients
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the PANSS positive scale
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the PANSS negative scale
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in PANSS General Psychopathology subscale
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16)
Time frame: baseline, up to 7 weeks of treatment
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Escondido, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Garden Grove, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paramount, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Washington D.C., District of Columbia, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Lauderdale, Florida, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hollywood, Florida, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Atlanta, Georgia, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago, Illinois, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hoffman Estates, Illinois, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lake Charles, Louisiana, United States
...and 18 more locations
A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS)
Time frame: baseline, up to 7 weeks of treatment
PANSS total score
Time frame: up to 7 weeks of treatment
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a female patients
Time frame: baseline, up to 7 weeks of treatment
Rate of discontinuation
Time frame: baseline, up to 7 weeks of treatment
Time to discontinuation
Time frame: baseline, up to 7 weeks of treatment
A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire
Time frame: baseline, up to 7 weeks of treatment
A change from baseline on resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM)
Time frame: Baseline up to 7 weeks of treatment
A change from baseline on functional capacity, as measured by the Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in Barnes Akathisia Scale (BAS)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in Simpson-Angus Scale (SAS)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: baseline, up to 7 weeks of treatment
A mean change from baseline in Prolactin levels
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in weight
Time frame: baseline, up to 7 weeks of treatment
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 7 weeks of treatment
Change from baseline in electrocardiogram parameters
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in neurological examination
Time frame: baseline, up to 7 weeks of treatment
Statistically different changes in vital signs from baseline
Time frame: baseline, up to 7 weeks of treatment
Statistically different changes in lab values from baseline
Time frame: baseline, up to 7 weeks of treatment
Population pharmacokinetics (PK) of LY2140023
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS)
Time frame: baseline, up to 7 weeks of treatment