Targacept completes patient recruitment for Phase 2b schizophrenia study of TC-5619

TC-5619 is developed as a treatment for negative symptoms and cognitive dysfunction in schizophrenia.

Targacept president and chief executive officer Dr. Stephen Hill said existing schizophrenia therapies primarily impact positive symptoms of schizophrenia, without treating the negative symptoms and cognitive dysfunction.

"A new and effective treatment that addresses this medical need would be critically important for the millions of schizophrenia patients unable to function in society," Hill added.

The ongoing parallel group, double blind study will randomise 456 stable schizophrenia patients receiving fixed dose of an atypical antipsychotic.

Placebo controlled study is designed to have a screening period of four weeks followed by a treatment period of 24 weeks.

Patients will receive one of two doses of TC-5619 (5mg or 50mg) or placebo once daily during the treatment period.

The Scale for the Assessment of Negative Symptoms (SANS) is the primary outcome measure.

The CogState Schizophrenia Battery (composite score), a computerised test battery, and the University of California, San Diego Performance-Based Skills Assessment, Brief Version are the key secondary outcome measures.

Top-line results from the study are expected by the end of 2013.