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

This study has been terminated.
(Safety event)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01568216
First received: February 27, 2012
Last updated: May 8, 2014
Last verified: May 2014

February 27, 2012
May 8, 2014
May 2012
June 2013   (final data collection date for primary outcome measure)
Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint
Same as current
Complete list of historical versions of study NCT01568216 on ClinicalTrials.gov Archive Site
  • Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    NSA-16 = 16-item Negative Symptom Assessment Scale
  • Change from baseline to week 12 on the PANSS total score and Marder factor scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale (PANSS)
  • Change from baseline to week 12 on the CGI-S [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Clinical Global Impression Severity Scale (CGI-S)
  • CGI-I scores at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression Improvement (CGI-I)
  • Change on cognition battery [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in personal and social functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change on patient reported outcomes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms
"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms"

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: AMG 747
    Three dose levels once-daily oral administration
  • Drug: Placebo
    Once-daily oral administration
  • Experimental: AMG 747 - Dose 1
    Intervention: Drug: AMG 747
  • Experimental: AMG 747 - Dose 2
    Intervention: Drug: AMG 747
  • Experimental: AMG 747 - Dose 3
    Intervention: Drug: AMG 747
  • Placebo Comparator: Placebo Comparator
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
121
August 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   New Zealand,   Russian Federation,   Singapore,   Spain
 
NCT01568216
20101299, 2011-004844-23
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP