Status:
COMPLETED
Adjuvant Treatment With a Glycine Uptake Inhibitor in Participants With Negative Symptoms of Schizophrenia (P05695) (MK-8435-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether MK-8435 (Org 25935) is more effective than placebo in improving negative symptoms in participants with schizophrenia who are concurrently treated with...
Detailed Description
The primary features of schizophrenia are characterized by positive (irrational thoughts and/or behavior) and negative symptoms. Negative symptoms are the gross absence of normal behavior and emotions...
Eligibility Criteria
Inclusion
- Is diagnosed with non-first episode schizophrenia meeting Diagnostic and Statistical Manual (Version IV) criteria
- Is receiving stable treatment with one of the following SGA: aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone
- Is in the non-acute phase of illness and clinically stable for 3 months prior to study start as demonstrated by: treatment with current SGA or at least 12 weeks prior to study start; no increase in the level of psychiatric care due to worsening symptoms for at least 12 weeks prior to study start; and no dose change of SGA or change in medication to treat the symptoms of schizophrenia for 4 weeks prior to study start
- Has a score ≥4 on 3 or more of the following Positive and Negative Symptoms Scale (PANSS) negative subscale items at study start: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance
- Has an overall PANSS negative subscale score \> 20
Exclusion
- Has an overall PANSS positive subscale score ≥20
- Has a score ≥5 on 2 or more of the following PANSS positive subscale items at study start: delusions, hallucinatory behavior, excitement, grandiosity, or suspiciousness/persecution
- Has a score ≥9 on the modified InterSePT Scale for Suicidal Thinking
- Has a score ≥9 on the Calgary Depression Scale for Schizophrenia
- Has a score ≥3 on the clinical global impression of Parkinsonism of the abbreviated Extrapyramidal Symptom Rating Scale
- Has untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, hematological, immunological or cerebrovascular disease, malignancy, or other chronic and/or degenerative process
- Has a history of seizure disorder beyond childhood or is taking any anticonvulsants to prevent seizures
- Has a diagnosis of mental retardation or organic brain syndrome
- Has a clinically relevant visual disturbance, such as cataract, color blindness, macular degeneration, glaucoma, or retinal disease
- Has a concurrent diagnosis of substance dependence other than nicotine or caffeine dependence in the past 6 months prior to study start
- Has a positive result on the urine alcohol/drug screen for alcohol or illicit drugs
- Is pregnant or breastfeeding
- Is being treated with high doses of benzodiazepines (\>4 mg per day lorazepam or equivalent)
- Has an imminent risk of self-harm or harm to others
- Has been treated with clozapine in the past 6 months prior to study start
- Has been treated with lithium, valproate, lamotrigine, pregabalin, gabapentin, or carbamazepine in the past 12 weeks prior to study start
- Has started treatment or has had a dose change of an (additional) antipsychotic, antidepressant,hypnotic or anxiolytic in the past 4 weeks prior to study start
- Has had no demonstrated benefit of antipsychotic treatment within the previous five years
Key Trial Info
Start Date :
April 10 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2008
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00725075
Start Date
April 10 2007
End Date
October 24 2008
Last Update
October 16 2018
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