20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms

Phase 2

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Primary Outcome Measures

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

Secondary Outcome Measures

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