Adjuvant Treatment With a Glycine Uptake Inhibitor in Participants With Negative Symptoms of Schizophrenia (P05695) (MK-8435-001)

• Status: Completed
• Trial end date: 2008-10-24
• Target enrollment: 0
• Participant gender: All

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 a stable dose of a second generation antipsychotic.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Antipsychotic Agents; Glycine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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