A Study in Schizophrenia Patients

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: LY2140023; Drug: Risperidone

• Registration Number: NCT01086748
• Lead Sponsor: Eli Lilly and Company

Brief Summary

An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Disposition First Submitted: 2012-09-18
• Disposition First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Disposition First Posted: 2012-09-25
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

• Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID).
• Non pregnant female patients who agree to use acceptable birth control
• At entry to the study must be considered moderately ill in the opinion of the investigator
• Willing to participate in a minimum of 3 weeks of inpatient hospitalization and this must be appropriate for the patient in the clinical judgment of the investigator.
• 1 year history of Schizophrenia prior to entering the study
• At study entry patients with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study. Patients who have never taken antipsychotic treatment may enter the study even without a history of hospitalization.
• At study entry patients with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Patients who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years.
• At study entry patients must have experienced an exacerbation of illness within the 2 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in patients who are presently hospitalized, the patient must not have been hospitalized longer than 60 days at entry of the study

Exclusion Criteria

• Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1

• Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity.

• Treatment with clozapine at doses greater than 200 mg daily within 12 months prior to entering the study, or who have received any clozapine at all during the month before entering the study

• Patients currently receiving treatment (within 1 dosing interval, minimum of 4 weeks, prior entering the study) with a depot formulation of an antipsychotic medication.

• Patients who are currently suicidal.

• Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study.

• Patients with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses

• Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years

• Patients are excluded if their, biological father, mother, brother, sister, or child has a history of idiopathic epilepsy.

• Within 1 year of study enrollment, patients have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive

• Patients are excluded if they have a lifetime history of any of the following:

  • head trauma, stroke, or CNS infection with persistent neurological deficit (focal or diffuse);
  • brain surgery;
  • an electroencephalogram with paroxysmal (epileptiform) activity, or
  • brain structural lesion, including developmental abnormalities, as determined by examination or previous neuroimaging studies that are consistent with a diagnosable neurological disease or syndrome.

• Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study.

• Leukopenia

• Medical history of Human Immunodeficiency Virus positive (HIV+) status.

• Higher than normal blood prolactin levels

• Certain electrocardiogram results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered orally, BID for up to 7 weeks.
160 mg LY2140023	LY2140023	80 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks.
4 mg Risperidone	Risperidone	2 mg risperidone administered orally, BID for up to 7 weeks.
80 mg LY2140023	LY2140023	40 mg LY2140023 administered orally, BID for up to 7 weeks.

Primary Outcome Measures

Name	Time	Method
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population	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	baseline, up to 7 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
A change from baseline in the PANSS negative scale	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	baseline, up to 7 weeks of treatment
A change from baseline in the PANSS positive scale	baseline, up to 7 weeks of treatment
Rate of discontinuation	baseline, up to 7 weeks of treatment
Time to discontinuation	baseline, up to 7 weeks of treatment
A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire	baseline, up to 7 weeks of treatment
A change from baseline on resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM)	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)	baseline, up to 7 weeks of treatment
A change from baseline in Barnes Akathisia Scale (BAS)	baseline, up to 7 weeks of treatment
A change from baseline in Simpson-Angus Scale (SAS)	baseline, up to 7 weeks of treatment
A change from baseline in Abnormal Involuntary Movement Scale (AIMS)	baseline, up to 7 weeks of treatment
A mean change from baseline in Prolactin levels	baseline, up to 7 weeks of treatment
A change from baseline in weight	baseline, up to 7 weeks of treatment
Number of Treatment Emergent Adverse Events (TEAEs)	Up to 7 weeks of treatment
Change from baseline in electrocardiogram parameters	baseline, up to 7 weeks of treatment
A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population	baseline, up to 7 weeks of treatment
A change from baseline in PANSS General Psychopathology subscale	baseline, up to 7 weeks of treatment
A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S)	baseline, up to 7 weeks of treatment
A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16)	baseline, up to 7 weeks of treatment
A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS)	baseline, up to 7 weeks of treatment
PANSS total score	up to 7 weeks of treatment
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a female patients	baseline, up to 7 weeks of treatment
Statistically different changes in vital signs from baseline	baseline, up to 7 weeks of treatment
Statistically different changes in lab values from baseline	baseline, up to 7 weeks of treatment
Population pharmacokinetics (PK) of LY2140023	baseline, up to 7 weeks of treatment
A change from baseline in neurological examination	baseline, up to 7 weeks of treatment
A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS)	baseline, up to 7 weeks of treatment

Trial Locations

Locations (1)

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.; 🇷🇺 Yaroslavl, Russian Federation