20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms
This study is currently recruiting participants.
Verified May 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01568229
First received: February 28, 2012
Last updated: May 6, 2013
Last verified: May 2013
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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: 12 weeks ] [ 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 ]
| Estimated Enrollment: | 270 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568229
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Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Hide Study LocationsLocations
| United States, Arkansas | |
| Research Site | Recruiting |
| Little Rock, Arkansas, United States, 72211 | |
| Research Site | Recruiting |
| Springdale, Arkansas, United States, 72764 | |
| Research Site | Completed |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Research Site | Recruiting |
| Long Beach, California, United States, 90813 | |
| Research Site | Recruiting |
| Oakland, California, United States, 94612 | |
| Research Site | Recruiting |
| Orange, California, United States, 92868 | |
| Research Site | Recruiting |
| San Diego, California, United States, 92105 | |
| United States, Florida | |
| Research Site | Recruiting |
| Kissimmee, Florida, United States, 34741 | |
| United States, Georgia | |
| Research Site | Recruiting |
| Atlanta, Georgia, United States, 30328 | |
| United States, Maryland | |
| Research Site | Recruiting |
| Rockville, Maryland, United States, 20850 | |
| United States, Mississippi | |
| Research Site | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| United States, New Jersey | |
| Research Site | Completed |
| Princeton, New Jersey, United States, 08540 | |
| United States, New York | |
| Research Site | Completed |
| Buffalo, New York, United States, 14215 | |
| Research Site | Recruiting |
| New York, New York, United States, 10027 | |
| United States, North Carolina | |
| Research Site | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Research Site | Completed |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Research Site | Recruiting |
| Scranton, Pennsylvania, United States, 18503 | |
| United States, Tennessee | |
| Research Site | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Research Site | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Research Site | Completed |
| Dallas, Texas, United States, 75230 | |
| Czech Republic | |
| Research Site | Recruiting |
| Brno, Czech Republic, 615 00 | |
| Research Site | Recruiting |
| Olomouc, Czech Republic, 779 00 | |
| Research Site | Recruiting |
| Praha 2, Czech Republic, 120 00 | |
| Research Site | Recruiting |
| Praha 9, Czech Republic, 190 00 | |
| Research Site | Recruiting |
| Prerov, Czech Republic, 750 01 | |
| Research Site | Recruiting |
| Strakonice, Czech Republic, 386 29 | |
| France | |
| Research Site | Recruiting |
| Clermont Ferrand, France, 63000 | |
| Research Site | Recruiting |
| Créteil cedex, France, 94010 | |
| Research Site | Recruiting |
| Dôle, France, 39100 | |
| Research Site | Recruiting |
| Montauban cedex, France, 82013 | |
| Research Site | Recruiting |
| Nimes, France, 30029 | |
| Malaysia | |
| Research Site | Recruiting |
| Ipoh, Perak, Malaysia, 30450 | |
| Research Site | Recruiting |
| Ipoh, Perak, Malaysia, 31250 | |
| Research Site | Recruiting |
| Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100 | |
| Research Site | Recruiting |
| Kuala Lumpur, Wilayah Persekutuan, Malaysia, 55100 | |
| Research Site | Recruiting |
| Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000 | |
| Poland | |
| Research Site | Recruiting |
| Bydgoszcz, Poland, 85-096 | |
| Research Site | Recruiting |
| Chelmno, Poland, 86-200 | |
| Research Site | Recruiting |
| Katowice, Poland, 40-340 | |
| Research Site | Recruiting |
| Skorzewo, Poland, 60-185 | |
| Research Site | Recruiting |
| Torun, Poland, 87-100 | |
| Research Site | Recruiting |
| Zuromin, Poland, 09-300 | |
| United Kingdom | |
| Research Site | Recruiting |
| Barnet, United Kingdom, EN5 3DJ | |
| Research Site | Recruiting |
| Edinburgh, United Kingdom, EH10 5HF | |
| Research Site | Recruiting |
| London, United Kingdom, SE5 8AF | |
| Research Site | Recruiting |
| Norwich, United Kingdom, NR1 3RE | |
| Research Site | Recruiting |
| Sheffield, United Kingdom, S10 3TH | |
| Research Site | Recruiting |
| Warrington, United Kingdom, WA2 8WA | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01568229 History of Changes |
| Other Study ID Numbers: | 20110165, 2011-004845-42 |
| Study First Received: | February 28, 2012 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
schizophrenia negative symptoms |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013