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Terminated/Withdrawn
Sponsor ID
20101299

20101299: Study to evaluate the effect of AMG 747 on schizophrenia negative symptoms

Sponsor ID
20101299
Clinicaltrials.gov ID
NCT01568216
EUCTIS ID
N/A
EudraCT ID
2011-004844-23
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Study Details

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

Additional Study Details

Phase
Phase 2
Product
AMG 747
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
121
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score

Timeframe: 12 Weeks

Secondary Outcome Measures

Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12

Timeframe: 12 weeks

Change from baseline to week 12 on the PANSS total score and Marder factor scores

Timeframe: 12 weeks

Change from baseline to week 12 on the CGI-S

Timeframe: Week 12

CGI-I scores at week 12

Timeframe: 12 weeks

Change on cognition battery

Timeframe: 12 weeks

Change in personal and social functioning

Timeframe: 12 weeks

Change on patient reported outcomes

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Houston, TX, United States, 77008
Status
Completed
Location
Research Site
Dayton, OH, United States, 45417
Status
Completed
Location
Research Site
Cerritos, CA, United States, 90703
Status
Completed
Location
Research Site
North Miami, FL, United States, 33161
Status
Completed
Location
Research Site
Garden Grove, CA, United States, 92845
Status
Completed
Location
Research Site
Melbourne, VIC, Australia, 3004
Status
Completed
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Study Info
Age
18 - 60 Years
Condition
  • Schizophrenia
    • Sex
    All
    Trial Dates
    May 2012 - Jun 2013
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia - 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:
    - Current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70 - 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