Bitopertin for schizophrenia: primary, persistent negative symptoms; sub-optimally controlled positive symptoms – in combination with antipsychotics

Mental Health, Drug Abuse and Learning Difficulties

Date of publication: 1st June 2012

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Technology description:

Bitopertin is intended to be used in combination with antipsychotics for the treatment of persistent negative symptoms pr sub-optimally controlled positive symptoms associated with schizophrenia. If licensed, bitopertin would represent the first in a new class of treatments for this patient group.

Schizophrenia is one of the most common forms of psychotic disorder with a lifetime risk of approximately 1%. The 2007 National Survey of Adult Psychiatric Morbidity in England found the overall population prevalence of psychotic disorder (including schizophrenia) to be 0.4% (0.3% men, 0.5% women) and the highest prevalence was observed in those aged 35 to 44 years. In 2010-11 there were 16,807 admissions for schizophrenia resulting in 2,403,719 bed days and 24,848 finished consultant episodes (ICD10 F20). While it estimated that around three quarters of patients with schizophrenia will suffer recurrent relapse and continued disability, longer-term studies suggest that there is a moderately good long-term outcome in over half of patients with schizophrenia, with a smaller proportion having extended periods of remission without further relapses.

The aims of treatment in schizophrenia are to manage acute episodes, prevent relapse and improve quality of life, with minimal adverse effects. There are currently a wide variety of pharmacological treatments which can be broadly categorised into typical (first-generation) or atypical (second-generation) antipsychotics. Non-pharmacological treatments include: individual psycho-education interventions, family interventions and cognitive behavioural therapy.

Bitopertin is currently in a number of phase III clinical trials comparing its effect on the symptoms of schizophrenia with placebo. Trials are expected to complete in 2015.