SchizophreniaPhase 2NCT01568229
20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)
A Phase 2 study testing AMG 747 in people with Schizophrenia, run by Amgen at 44 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- AMG 747
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 44 sitesin 6 countries
- Study dates
- May 2012to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
United States17 sites
Research Site
Atlanta, Georgia, 30328
Research Site
Buffalo, New York, 14215
Research Site
Dallas, Texas, 75230
Research Site
Durham, North Carolina, 27710
Research Site
Flowood, Mississippi, 39232
Research Site
Hialeah, Florida, 33018
Research Site
Kissimmee, Florida, 34741
Research Site
Little Rock, Arkansas, 72211
Research Site
Long Beach, California, 90813
Research Site
Memphis, Tennessee, 38119
Research Site
New York, New York, 10027
Research Site
Oakland, California, 94612
Research Site
Orange, California, 92868
Research Site
Princeton, New Jersey, 08540
Research Site
Rockville, Maryland, 20850
Research Site
Scranton, Pennsylvania, 18503
Research Site
Springdale, Arkansas, 72764
Czechia6 sites
Research Site
Brno, 615 00
Research Site
Olomouc, 779 00
Research Site
Prague, 120 00
Research Site
Prague, 190 00
Research Site
Přerov, 750 01
Research Site
Strakonice, 386 29
Poland6 sites
Research Site
Bydgoszcz, 85-096
Research Site
Chełmno, 86-200
Research Site
Katowice, 40-340
Research Site
Skorzewo, 60-185
Research Site
Torun, 87-100
Research Site
Żuromin, 09-300
United Kingdom6 sites
Research Site
Barnet, EN5 3DJ
Research Site
Edinburgh, EH10 5HF
Research Site
London, SE5 8AF
Research Site
Norwich, NR1 3RE
Research Site
Sheffield, S10 3TH
Research Site
Warrington, WA2 8WA
Malaysia5 sites
Research Site
Ipoh, Perak, 30450
Research Site
Ipoh, Perak, 31250
Research Site
Kuala Lumpur, Kuala Lumpur, 55100
Research Site
Kuala Lumpur, Kuala Lumpur, 56000
Research Site
Kuala Lumpur, Kuala Lumpur, 59100
France4 sites
Research Site
Créteil, 94010
Research Site
Dôle, 39100
Research Site
Montauban, 82013
Research Site
Nîmes, 30029
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms
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.
- Conditions
- Schizophrenia
- Being tested
- AMG 747, Placebo
- Keywords
- schizophrenia negative symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 747Drug
Three dose levels once-daily oral administration
PlaceboDrug
Once-daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| AMG 747 - Dose 1 | Experimental | Not described Receives: Drug: AMG 747 |
| AMG 747 - Dose 2 | Experimental | Not described Receives: Drug: AMG 747 |
| AMG 747 - Dose 3 | Experimental | Not described Receives: Drug: AMG 747 |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint
Measured: 12 Weeks
Secondary outcomes (7)
Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12
NSA-16 = 16-item Negative Symptom Assessment Scale
Measured: 12 Weeks
Change from baseline to week 12 on the PANSS total score and Marder factor scores
Positive and Negative Syndrome Scale (PANSS)
Measured: 12 weeks
Change from baseline to week 12 on the CGI-S
Clinical Global Impression Severity Scale (CGI-S)
Measured: 12 weeks
CGI-I scores at week 12
Clinical Global Impression Improvement (CGI-I)
Measured: 12 weeks
Change on cognition battery
Measured: 12 weeks
Change in personal and social functioning
Measured: 12 weeks
Change on patient reported outcomes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionAug 2013
Why it stopped: Toxic Epidermal Necrolysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568229
- Sponsor's protocol ID
- 20110165
- Other IDs
- 2011-004845-42
- Status last verified
- Sep 2014
- First submitted
- 28 Feb 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.
PubMed 27789188
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms
- ClinicalTrials.gov ID
- NCT01568229
- Acronym / sponsor ID
- 20110165
- Conditions
- Schizophrenia
- Keywords
- schizophrenia negative symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Toxic Epidermal Necrolysis
- Enrolment
- 111 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMG 747 - Dose 1 | Experimental | Drug: AMG 747 |
| AMG 747 - Dose 2 | Experimental | Drug: AMG 747 |
| AMG 747 - Dose 3 | Experimental | Drug: AMG 747 |
| Placebo Comparator | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 747Three dose levels once-daily oral administration | Drug | AMG 747 - Dose 1, AMG 747 - Dose 2, AMG 747 - Dose 3 |
| PlaceboOnce-daily oral administration | Drug | Placebo Comparator |
Primary outcome
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
7 secondary outcomes
Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12
Time frame: 12 Weeks
Change from baseline to week 12 on the PANSS total score and Marder factor scores
Time frame: 12 weeks
Change from baseline to week 12 on the CGI-S
Time frame: 12 weeks
CGI-I scores at week 12
Time frame: 12 weeks
Change on cognition battery
Time frame: 12 weeks
Change in personal and social functioning
Time frame: 12 weeks
Change on patient reported outcomes
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Toxic Epidermal Necrolysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Derived from this study: PubMed 27789188Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 747 in people with Schizophrenia, run by Amgen at 44 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Czechia, Poland, United Kingdom, Malaysia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Toxic Epidermal Necrolysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01568229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.