20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms
NCT ID: NCT01568216
Last Updated: 2015-07-30
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
121 participants
INTERVENTIONAL
2012-05-31
2013-06-30
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
Anaheim, California, United States
Research Site
Cerritos, California, United States
Research Site
Culver City, California, United States
Research Site
Garden Grove, California, United States
Research Site
Los Angeles, California, United States
Research Site
Norwalk, California, United States
Research Site
San Bernardino, California, United States
Research Site
Torrance, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
North Miami, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Marlton, New Jersey, United States
Research Site
Glen Oaks, New York, United States
Research Site
Rochester, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Dayton, Ohio, United States
Research Site
Houston, Texas, United States
Research Site
Glenside, South Australia, Australia
Research Site
Melbourne, Victoria, Australia
Research Site
Mount Claremont, Western Australia, Australia
Research Site
Calgary, Alberta, Canada
Research Site
Penticton, British Columbia, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Takapuna, Auckland, , New Zealand
Research Site
Khot'kovo, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saratov, , Russia
Research Site
Singapore, , Singapore
Research Site
Santander, Cantabria, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Cornellà de Llobregat, Catalonia, Spain
Research Site
L'Hospitalet de Llobregat, Catalonia, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Valencia, Valencia, Spain
Countries
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References
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Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
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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2011-004844-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20101299
Identifier Type: -
Identifier Source: org_study_id
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