Clinical trial NCT01568229: 20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia negative symptoms
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
timeFrame: 12 Weeks
Secondary outcomes:
measure: Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12
timeFrame: 12 Weeks
measure: Change from baseline to week 12 on the PANSS total score and Marder factor scores
timeFrame: 12 weeks
measure: Change from baseline to week 12 on the CGI-S
timeFrame: 12 weeks
measure: CGI-I scores at week 12
timeFrame: 12 weeks
measure: Change on cognition battery
timeFrame: 12 weeks
measure: Change in personal and social functioning
timeFrame: 12 weeks
measure: Change on patient reported outcomes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Springdale
country: United States
facility: Research Site
state: Arkansas
city: Long Beach
country: United States
facility: Research Site
state: California
city: Oakland
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Kissimmee
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: Princeton
country: United States
facility: Research Site
state: New Jersey
city: Buffalo
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Scranton
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Brno
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 9
country: Czech Republic
facility: Research Site
city: Prerov
country: Czech Republic
facility: Research Site
city: Strakonice
country: Czech Republic
facility: Research Site
city: Créteil cedex
country: France
facility: Research Site
city: Dôle
country: France
facility: Research Site
city: Montauban cedex
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Ipoh
country: Malaysia
facility: Research Site
state: Perak
city: Ipoh
country: Malaysia
facility: Research Site
state: Perak
city: Kuala Lumpur
country: Malaysia
facility: Research Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Research Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Research Site
state: Wilayah Persekutuan
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chelmno
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Skorzewo
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Zuromin
country: Poland
facility: Research Site
city: Barnet
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Warrington
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.