20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)
NCT ID: NCT01568229
Last Updated: 2014-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
111 participants
INTERVENTIONAL
2012-05-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AMG 747 - Dose 1
AMG 747
Three dose levels once-daily oral administration
AMG 747 - Dose 2
AMG 747
Three dose levels once-daily oral administration
AMG 747 - Dose 3
AMG 747
Three dose levels once-daily oral administration
Placebo Comparator
Placebo
Once-daily oral administration
Interventions
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AMG 747
Three dose levels once-daily oral administration
Placebo
Once-daily oral administration
Eligibility Criteria
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Inclusion Criteria
* Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) ≥ 20
* Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) ≤ 30
* Receiving stable antipsychotic therapy for at least 8 weeks prior to screening
* Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening
* Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study
* The subject or subject's legally acceptable representative has provided informed consent.
Exclusion Criteria
* Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam
* Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening
* Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening
* Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study
* Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).
* Other criteria may apply
18 Years
60 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Little Rock, Arkansas, United States
Research Site
Springdale, Arkansas, United States
Research Site
Long Beach, California, United States
Research Site
Oakland, California, United States
Research Site
Orange, California, United States
Research Site
Hialeah, Florida, United States
Research Site
Kissimmee, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Rockville, Maryland, United States
Research Site
Flowood, Mississippi, United States
Research Site
Princeton, New Jersey, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Scranton, Pennsylvania, United States
Research Site
Memphis, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Brno, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Přerov, , Czechia
Research Site
Strakonice, , Czechia
Research Site
Créteil, , France
Research Site
Dôle, , France
Research Site
Montauban, , France
Research Site
Nîmes, , France
Research Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Research Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Research Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Research Site
Ipoh, Perak, Malaysia
Research Site
Ipoh, Perak, Malaysia
Research Site
Bydgoszcz, , Poland
Research Site
Chełmno, , Poland
Research Site
Katowice, , Poland
Research Site
Skorzewo, , Poland
Research Site
Torun, , Poland
Research Site
Żuromin, , Poland
Research Site
Barnet, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Norwich, , United Kingdom
Research Site
Sheffield, , United Kingdom
Research Site
Warrington, , United Kingdom
Countries
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References
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Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2011-004845-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110165
Identifier Type: -
Identifier Source: org_study_id
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