Schizophrenia Clinical Trial
Official title:
A Multi-center, Double-blind, Flexible-dose Efficacy Trial With Org 25935 Versus Placebo as add-on Therapy in Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia Treated With a Stable Dose of a Second Generation Antipsychotic (GIANT)
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.
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, and usually include a general lack of engagement, social withdrawal,
and loss of goal-directed behavior.
Negative symptoms may strongly affect daytime activities and quality of life. The effects of
currently available antipsychotics on negative symptoms are not satisfactory and leave much
room for improvement. MK-8435 (Org 25935) is an investigational drug that may help to correct
the above characteristics of schizophrenia by facilitating the messenger function of an amino
acid in the brain, called glutamate. Preliminary data suggest that lowered glutamate levels
in schizophrenia are associated with a failure to activate relevant areas in the forebrain
and with prominent negative symptoms.
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