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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Schizophrenia
Unfortunately contact details are not available for this trial.
Primary Contact Details
Stopped
Recruitment Status
NCT01568229
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : AMG 747, Drug : Placebo

Study Arm Groups : AMG 747 - Dose 1, AMG 747 - Dose 2, AMG 747 - Dose 3, Placebo Comparator

Intervention Type
See Interventions above
Primary Outcome Measures
  • Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score; 12 Weeks
Secondary Outcome Measures
  • Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12; 12 Weeks; Change from baseline to week 12 on the PANSS total score and Marder factor scores; 12 weeks; Change from baseline to week 12 on the CGI-S; 12 weeks; CGI-I scores at week 12; 12 weeks; Change on cognition battery; 12 weeks; Change in personal and social functioning; 12 weeks; Change on patient reported outcomes; 12 weeks
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 60 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
London
SE5 8AF
Novartis Investigative Site
Edinburgh
EH10 5HF
Primary Care Health and Medical Psychology Services
Sheffield
South Yorkshire
S10 3TH
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barnet
Herts
EN5 3DJ
Norwich
NR1 3RE
Site Reference ID/Investigator# 67783
Warrington
WA2 8WA
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Czech Republic, France, Malaysia, Poland, United Kingdom
Scientific Title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
20110165
Sponsor(s)
Amgen
Key Dates

Recruitment Start Date

May 2012

Recruitment End Date

Jun 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

28 Feb 2012

Last Updated

19 Sep 2014