A Study in Schizophrenia Patients

Schizophrenia Clinical Trial

Official title:

A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086748
• Other study ID #: 11958
• Secondary ID: H8Y-MC-HBBM
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2010
• Last updated: September 18, 2012
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCroatia: Ethics CommitteeCroatia: Ministry of Health and Social CareGermany: Ethics CommissionGermany: Ministry of HealthRussia: Ethics CommitteeRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Risperidone
Administered orally.
• Placebo
Administered orally.
• LY2140023
Administered orally.

Locations

Country	Name	City	State
Croatia	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.	Zagreb
Russian Federation	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.	Khotkovo
Russian Federation	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.	Lipetsk
Russian Federation	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.	Moscow
Russian Federation	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.	Nizhniy Novgorod
Russian Federation	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.	Saint Petersburg
Russian Federation	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.	Samara
Russian Federation	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.	Saratov
Russian Federation	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
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.	Austin	Texas
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.	Cedarhurst	New York
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.	Creve Coeur	Missouri
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.	Desoto	Texas
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.	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.	Flowood	Mississippi
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.	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.	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.	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.	Houston	Texas
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	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.	Philadelphia	Pennsylvania
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.	Rochester	New York
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.	Shreveport	Louisiana
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	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Croatia,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population		baseline, up to 7 weeks of treatment	No
Secondary	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	No
Secondary	A change from baseline in the PANSS positive scale		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline in the PANSS negative scale		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline in PANSS General Psychopathology subscale		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S)		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16)		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline in the Montgomery-?sberg Depression Rating Scale (MADRS)		baseline, up to 7 weeks of treatment	No
Secondary	PANSS total score		up to 7 weeks of treatment	No
Secondary	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	No
Secondary	Rate of discontinuation		baseline, up to 7 weeks of treatment	No
Secondary	Time to discontinuation		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline on resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM)		Baseline up to 7 weeks of treatment	No
Secondary	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	No
Secondary	A change from baseline in Barnes Akathisia Scale (BAS)		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline in Simpson-Angus Scale (SAS)		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline in Abnormal Involuntary Movement Scale (AIMS)		baseline, up to 7 weeks of treatment	No
Secondary	A mean change from baseline in Prolactin levels		baseline, up to 7 weeks of treatment	Yes
Secondary	A change from baseline in weight		baseline, up to 7 weeks of treatment	Yes
Secondary	Number of Treatment Emergent Adverse Events (TEAEs)		Up to 7 weeks of treatment	Yes
Secondary	Change from baseline in electrocardiogram parameters		baseline, up to 7 weeks of treatment	Yes
Secondary	A change from baseline in neurological examination		baseline, up to 7 weeks of treatment	Yes
Secondary	Statistically different changes in vital signs from baseline		baseline, up to 7 weeks of treatment	Yes
Secondary	Statistically different changes in lab values from baseline		baseline, up to 7 weeks of treatment	Yes
Secondary	Population pharmacokinetics (PK) of LY2140023		baseline, up to 7 weeks of treatment	No
Secondary	A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS)		baseline, up to 7 weeks of treatment	Yes