Clinical trial NCT01129674: A Long-Term, Open-Label, Study on Schizophrenia
Official title: A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-05-25
Enrollment: 1210
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 primary purpose of the study is to help answer the following research questions:

How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care treatment in 52 weeks time period.

Whether LY 2140023 can help patients with Schizophrenia.

Detailed description: The study includes 2 treatment periods. Study Period I will begin at patient randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for patients randomized to treatment with LY2140023, and will begin after the patient has completed the second year of treatment. Patients who qualify for enrollment will be randomized in a 3:1 ratio (LY2140023 versus standard of care, respectively) into 2 treatment groups: flexible, twice-daily dose of LY2140023 or standard-of-care (olanzapine, risperidone, aripiprazole, or quetiapine). Those assigned to LY2140023 will have the option to continue on LY2140023 after 2 years if deemed appropriate by the investigator.

Eligibility criteria: Inclusion Criteria:

* Must have met all entry criteria for, and have completed, an acute, placebo-controlled clinical trial of LY2140023 (such as Study H8Y-MC-HBBM, or other acute, placebo-controlled LY2140023 studies if allowed by the protocols for those studies).
* Female patients of childbearing potential must agree to use a single, effective, medically acceptable method of birth control.
* Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol.
* Patients must be able to understand the nature of the study and have given their own informed consent.

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or nonapproved use of a drug or device (other than LY2140023), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Patients for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated.
* Patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to study enrollment, or who have received any clozapine at all during the month before study enrollment.
* Patients who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed in study protocol.
* Patients have risk of suicide.
* Patients diagnosed with substance dependence or substance abuse within the 6 months prior to study enrollment.
* Patients diagnosed with substance-induced psychosis within 7 days of study enrollment or at any time during the study.
* Female patients who are pregnant, nursing, lactating or who intend to become pregnant within 30 days of completing the study.
* Have known glaucoma.
* Have a history of some types of seizures.
* Have seizure liability inconsistent with the exclusion criteria of the completed acute feeder study.
* Patients who have had electroconvulsive therapy (ECT) within 3 months of study enrollment or who will have ECT at any time during the study.
* Patients with known Human Immunodeficiency Virus positive (HIV+) status.
* Patients have a serious disease, such as recent stroke, heart, liver, kidney, lung or blood diseases
* Patients with Parkinson's disease
* Are incapable of participating in the study or are unwilling to engage in a meaningful way as study participants.

Primary outcomes:
measure: Time to discontinuation due to adverse events
timeFrame: Baseline through 52 weeks
Secondary outcomes:
measure: Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale)
timeFrame: Baseline, 52 weeks
measure: Change from baseline to 52 week endpoint in Clinical Global Impression-Severity (CGI-S)
timeFrame: Baseline, 52 weeks
measure: Change from baseline to 52 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)
timeFrame: Baseline, 52 weeks
measure: The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 52 weeks, 104 weeks, end of study
measure: Change from baseline to 52 week endpoint in PSP scale (Personal and Social Performance)
timeFrame: Baseline, 52 weeks
measure: Change from baseline to 52 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)
timeFrame: Baseline, 52 weeks
measure: Change from baseline to 104 week endpoint in the Schizophrenia Resource Use Model (S-RUM)
timeFrame: Baseline, 104 weeks
measure: Change from baseline to 104 week endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)
timeFrame: Baseline, 104 weeks
measure: Change from 52 week to 104 week endpoint in PANSS (Positive and Negative Syndrome Scale)
timeFrame: 52 weeks, 104 weeks
measure: Change from 52 week to 104 week endpoint in Clinical Global Impression-Severity (CGI-S)
timeFrame: 52 weeks, 104 weeks
measure: Change from 52 week to 104 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)
timeFrame: 52 weeks, 104 weeks
measure: Change from 104 week to study endpoint in Clinical Global Impression-Severity (CGI-S)
timeFrame: 104 weeks, end of study
measure: Change from baseline to 104 week endpoint in PSP scale (Personal and Social Performance)
timeFrame: Baseline, 104 weeks
measure: Change from baseline to 104 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)
timeFrame: Baseline, 104 weeks
measure: Change from Baseline to 52 week endpoint in the Schizophrenia Resource Use Model (S-RUM)
timeFrame: Baseline, 52 weeks
measure: Change from 104 week to study endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)
timeFrame: 104 weeks, end of study
measure: Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) in a genetically defined subgroup
timeFrame: Baseline, 52 Weeks
Other outcomes:
Locations:
city: Little Rock
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: Arkansas
city: Escondido
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: Garden Grove
country: United States
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state: California
city: Long Beach
country: United States
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state: California
city: National City
country: United States
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state: California
city: Oakland
country: United States
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state: California
city: Oceanside
country: United States
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state: California
city: Paramount
country: United States
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state: California
city: Pasadena
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: Sherman Oaks
country: United States
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state: California
city: Torrance
country: United States
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state: California
city: Washington
country: United States
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state: District of Columbia
city: Fort Lauderdale
country: United States
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state: Florida
city: Hollywood
country: United States
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state: Florida
city: Kissimmee
country: United States
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state: Florida
city: Maitland
country: United States
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state: Florida
city: University Park
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Chicago
country: United States
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state: Illinois
city: Hoffman Estates
country: United States
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state: Illinois
city: Indianapolis
country: United States
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state: Indiana
city: Wichita
country: United States
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state: Kansas
city: Lake Charles
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Flowood
country: United States
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state: Mississippi
city: Creve Coeur
country: United States
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state: Missouri
city: Marlton
country: United States
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state: New Jersey
city: Buffalo
country: United States
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state: New York
city: Cedarhurst
country: United States
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state: New York
city: Holliswood
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Cincinnati
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Philadelphia
country: United States
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state: Pennsylvania
city: Austin
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Desoto
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Richmond
country: United States
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state: Virginia
city: Roanoke
country: United States
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state: Virginia
city: Zagreb
country: Croatia
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city: Aichi
country: Japan
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city: Kanagawa
country: Japan
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city: Kumamoto
country: Japan
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city: Kyoto
country: Japan
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city: Nagano
country: Japan
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city: Nagasaki
country: Japan
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city: Nara
country: Japan
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city: Osaka
country: Japan
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city: Saga
country: Japan
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city: Tokyo
country: Japan
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city: Toyama
country: Japan
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city: Goyang-Si
country: Korea, Republic of
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city: Incheon
country: Korea, Republic of
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city: Naju
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Suwon-City
country: Korea, Republic of
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city: Yongin
country: Korea, Republic of
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city: Guadalajara
country: Mexico
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city: Monterrey
country: Mexico
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city: Ponce
country: Puerto Rico
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city: San Juan
country: Puerto Rico
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city: Khotkovo
country: Russian Federation
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: Lipetsk
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Nizhniy Novgorod
country: Russian Federation
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: Saint Petersburg
country: Russian Federation
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: Samara
country: Russian Federation
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: Saratov
country: Russian Federation
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: Tomsk
country: Russian Federation
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: Voronezh
country: Russian Federation
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: Yaroslavl
country: Russian Federation
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: Changhua
country: Taiwan
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: Neihu Taipei
country: Taiwan
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: Taipei
country: Taiwan
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: Donetsk
country: Ukraine
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: Kherson
country: Ukraine
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: Kiev
country: Ukraine
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: Vinnytsya
country: Ukraine
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: