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New research for your patients with unresolved negative symptoms of schizophrenia whose disease is otherwise well managed.
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About Negative Symptoms of Schizophrenia
Advances in schizophrenia treatment for patients through second generation anti-psychotic medications have done much to help this population better manage their positive symptoms. However, negative symptoms may not respond to these traditional therapies, and there are no FDA-approved medications specifically for negative symptoms of schizophrenia. Approximately 60% of stable outpatients with schizophrenia have at least one negative symptom.
A New Research Study is Underway
For that reason, Otsuka America Pharmaceutical, Inc. has launched a Phase 2/3 clinical research study designed to assess the efficacy, safety, and tolerability of AVP-786, an adjuvant investigational drug for the treatment of negative symptoms in otherwise well-managed adult patients. AVP-786 is an oral capsule which contains the active ingredients deudextromethorphan hydrobromide and quinidine sulfate. For purposes of this research study, it is administered twice daily by the patient or their reliable study partner. Participation in the clinical study is expected to last a total of 23 weeks. All study-related visits, tests, and study drugs will be provided at no-cost to the patient. You will continue to be their physician for non-study related needs.
Which Patients May Be Eligible to Enroll?
To be eligible for this study, potential participants must:
- Be 18 to 60 years of age, inclusive.
- Meet diagnostic criteria for schizophrenia, with onset at least one year before screening and have been clinically stable for at least six months.
- Be treated with a second-generation atypical antipsychotic other than clozapine.
- Have negative symptoms that have been present for at least six months.
- Have a reliable study partner (e.g., case manager, social worker, family member).