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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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: AMG 747
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms"

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 121
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 747 - Dose 1 Drug: AMG 747
Three dose levels once-daily oral administration
Experimental: AMG 747 - Dose 2 Drug: AMG 747
Three dose levels once-daily oral administration
Experimental: AMG 747 - Dose 3 Drug: AMG 747
Three dose levels once-daily oral administration
Placebo Comparator: Placebo Comparator Drug: Placebo
Once-daily oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568216

  Show 38 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01568216     History of Changes
Other Study ID Numbers: 20101299, 2011-004844-23
Study First Received: February 27, 2012
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
schizophrenia negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2014