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

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

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