Phase-Three Clinical Trial of a New Schizophrenia Drug Shows Promising Results

Schizophrenia is one of the most common serious mental health conditions. The main symptoms of schizophrenia fall into three categories- positive symptoms, such as delusions and hallucinations; negative symptoms, such as lack of drive and social withdrawal; and cognitive symptoms, such as problems with attention and memory. The negative symptoms usually tend to persist, and do not respond well to current treatment. Results of a phase-three clinical trial of an investigational drug, called cariprazine, suggests that it may provide effective treatment for these negative symptoms associated with schizophrenia. Cariprazine has been developed by Hungary-based pharmaceutical company Gedeon Richter. Lead researcher Gyorgy Nemeth, chief medical officer at Gedeon Richter, said, "The positive symptoms of schizophrenia can be controlled by drugs, but this is the first study ever to show a significant effect of a compound on negative symptom compared to another antipsychotic. Effective medicines (antipsychotics) exist for positive symptoms, but negative symptoms and cognitive impairment do not respond well to the available treatments. It seems that with cariprazine, we may be able to treat both the positive and negative symptoms with a single medication."

For the study, researchers enrolled 461 men and women in the clinical trial, to compare cariprazine against risperidone (which is commonly used to treat schizophrenia). The outcomes were measured using a special subscale of the PANSS scale (Positive and Negative Syndrome Scale) which is a standard method used for measuring the severity of symptoms of patients with schizophrenia.

Following 26 weeks of treatment, it was found that cariprazine treatment group showed a statistically significant improvement in the PANSS-NFS scale relative to risperidone. In addition to the effect on predominant negative symptoms of schizophrenia, subjects who took cariprazine also performed significantly better on personal and social functioning than those who took risperidone. The trial was organized and supported by Gedeon Richter pharmaceutical company.

The study findings were presented at the European College of Neuropsychopharmacology conference in Amsterdam, the Netherlands.

Source-IANS