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

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ClinicalTrials.gov Identifier: NCT01568216
Recruitment Status : Terminated (Toxic Epidermal Necrolysis)
First Posted : April 2, 2012
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: AMG 747 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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"
Study Start Date : May 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score [ Time Frame: 12 Weeks ]
    NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint


Secondary Outcome Measures :
  1. Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12 [ Time Frame: 12 weeks ]
    NSA-16 = 16-item Negative Symptom Assessment Scale

  2. Change from baseline to week 12 on the PANSS total score and Marder factor scores [ Time Frame: 12 weeks ]
    Positive and Negative Syndrome Scale (PANSS)

  3. Change from baseline to week 12 on the CGI-S [ Time Frame: Week 12 ]
    Clinical Global Impression Severity Scale (CGI-S)

  4. CGI-I scores at week 12 [ Time Frame: 12 weeks ]
    Clinical Global Impression Improvement (CGI-I)

  5. Change on cognition battery [ Time Frame: 12 weeks ]
  6. Change in personal and social functioning [ Time Frame: 12 weeks ]
  7. Change on patient reported outcomes [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568216


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01568216     History of Changes
Other Study ID Numbers: 20101299
2011-004844-23 ( EudraCT Number )
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by Amgen:
schizophrenia negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders