20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: AMG 747
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 747 - Dose 1<br> | Drug: AMG 747<br>* Three dose levels once-daily oral administration<br>|
| Experimental: AMG 747 - Dose 2<br> | Drug: AMG 747<br>* Three dose levels once-daily oral administration<br>|
| Experimental: AMG 747 - Dose 3<br> | Drug: AMG 747<br>* Three dose levels once-daily oral administration<br>|
| Placebo Comparator: Placebo Comparator<br> | Drug: Placebo<br>* Once-daily oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score | NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12 | NSA-16 = 16-item Negative Symptom Assessment Scale | 12 Weeks | 
| Change from baseline to week 12 on the PANSS total score and Marder factor scores | Positive and Negative Syndrome Scale (PANSS) | 12 weeks | 
| Change from baseline to week 12 on the CGI-S | Clinical Global Impression Severity Scale (CGI-S) | 12 weeks | 
| CGI-I scores at week 12 | Clinical Global Impression Improvement (CGI-I) | 12 weeks | 
| Change on cognition battery |  | 12 weeks | 
| Change in personal and social functioning |  | 12 weeks | 
| Change on patient reported outcomes |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia negative symptoms