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Health Condition(s) or Problem
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Schizophrenia
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Drug; AMG 747; Three dose levels once-daily oral administration; AMG 747 - Dose 1; AMG 747 - Dose 2; AMG 747 - Dose 3; Drug; Placebo; Once-daily oral administration; Placebo Comparator
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Primary aim
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Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
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Secondary Aim
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Response defined as a = 20% decrease in the NSA-16 total score at week 12; 12 Weeks; No; NSA-16 = 16-item Negative Symptom Assessment Scale; Change from baseline to week 12 on the PANSS total score and Marder factor scores; 12 weeks; No; Positive and Negative Syndrome Scale (PANSS); Change from baseline to week 12 on the CGI-S; 12 weeks; No; Clinical Global Impression Severity Scale (CGI-S); CGI-I scores at week 12; 12 weeks; No; Clinical Global Impression Improvement (CGI-I); Change on cognition battery; 12 weeks; No; Change in personal and social functioning; 12 weeks; No; Change on patient reported outcomes; 12 weeks; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://www.amgentrials.com
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Recruitment Status
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Recruiting
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Nation
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England, Scotland
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Location
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Barnet, Edinburgh, London, Norwich, Sheffield, Warrington
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