Clinical trial NCT01052103: A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms
Official title: A 17-Week, Phase 2, Multicenter, Randomized, Double-Blind Study of Treatment With LY2140023 Combined With Standard of Care (SOC) Compared to Placebo With SOC in the Treatment of Patients With Prominent Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Denovo Biopharma LLC
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.

Detailed description: The primary objective of this study was to test the hypothesis that treatment with LY2140023 compared to placebo, when added to a fixed dose of a standard of care (SOC) antipsychotic, would demonstrate significantly greater reduction of negative symptoms, as assessed by the 16-item Negative Symptom Assessment scale (NSA-16), in patients with schizophrenia. Patients included in this study were concurrently receiving 1 of 4 second generation antipsychotics (SGAs): aripiprazole, olanzapine, risperidone, or quetiapine.

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

Primary outcomes:
measure: Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16)
timeFrame: Baseline, randomization treatment Week 16
Secondary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline in Barnes-Akathisia Scale (BAS) Global Score
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Baseline, randomization treatment Week 16
measure: Number of Participants With Incidence of Epileptiform Activity Outside of Normal Range in Electroencephalograms (EEGs)
timeFrame: Baseline to randomization treatment Week 16
measure: Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs)
timeFrame: Baseline to randomization treatment Week 16
measure: Percentage of Participants With a Worsening of Neurological Symptoms From Baseline to Endpoint on the Neurological Examination
timeFrame: Baseline to randomization treatment Week 16
measure: Change From Baseline in Standing Blood Pressure (BP)
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline in Standing Pulse Rate
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline in Weight
timeFrame: Baseline, randomization treatment Week 16
measure: Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - General
timeFrame: Baseline to randomization treatment Week 16
measure: Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Cholesterol
timeFrame: Baseline to randomization treatment Week 16
measure: Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Triglycerides
timeFrame: Baseline to randomization treatment Week 16
measure: Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Glucose
timeFrame: Baseline to randomization treatment Week 16
measure: Percentage of Participants With Incidence of Potentially Clinically Significant Change of Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline to randomization treatment Week 16
measure: Change From Baseline to Endpoint in Personal and Social Performance (PSP) Scale
timeFrame: Baseline, randomization treatment Week 16
measure: Time to Discontinuation From the Study Due to Any Reason
timeFrame: First dose to randomization treatment Week 16
measure: Schizophrenia Resource Use Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits
timeFrame: Baseline to randomization treatment Week 16
measure: Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist
timeFrame: Baseline to randomization treatment Week 16
measure: Change From Baseline to Endpoint in the EuroQol Questionnaire-5 Dimension (EQ-5D) Visual Analog Scale (VAS) Health State Score
timeFrame: Baseline, randomization treatment Week 16
measure: Change From Baseline to Endpoint in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-SF) Total Score
timeFrame: Baseline, randomization treatment Week 16
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: 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.
state: California
city: Chicago
country: United States
facility: 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.
state: Illinois
city: Hoffman Estates
country: United States
facility: 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.
state: Illinois
city: New York
country: United States
facility: 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.
state: New York
city: Jerusalem
country: Israel
facility: 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.
city: Parma
country: Italy
facility: 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.
city: Torino
country: Italy
facility: 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.
city: Barcelona
country: Spain
facility: 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.
city: Zamora
country: Spain
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: