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

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Medical Conditions
  • Schizophrenia
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Stopped
Trial source and source ID number
NCT01568229

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
SE5 8AF
Edinburgh
EH10 5HF
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
Sheffield Health and Social Care Nhs Foundation Trust
Sheffield
S10 3TH
Norwich
NR1 3RE
Novartis Investigative Site
Winwick
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
Czech Republic, France, Malaysia, Poland, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

28 Feb 2012

Date updated in source

19 Sep 2014