A post-marketing surveillance study on the effectiveness and safety of paliperidone ER among Filipino adult patients diagnosed with Schizophrenia

BACKGROUND: Schizophrenia affects 7 people per 1000 adult population worldwide and is a severe form of mental illness common in age group 15-35 year old. Paliperidone is the active metabolite of risperidone and was approved for treatment of schizophrenia in the Philippines by the Food and Drug Administration (FDA) in 2007. The drug has been shown to be safe and effective in clinical trials but no local study has investigated its effect among Filipino patients. Hence, the general objective of this study was to assess the safety and effectiveness of paliperidone ER among Filipino patients diagnosed with schizophrenia. METHODS: The study was a non-randomized, non-comparative, open-label trial involving adult patients seen at initial consult and at the end of study visit. Study duration was eight weeks and was conducted for three years as required by the FDA. The primary outcome for the study was overall severity of the illness at the initial visit and end visit (visit 2) using the Clinical Global Impression tool (CGI-S). This rating scale was used to rate the severity of a subject's pyschotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). RESULTS: A total of 641 Filipino adults were enrolled in the study. Ninety one percent (N=586) had completed the follow-up into the second or end visit resulting in a 9% drop out for the duration of the study. Follow-up period had an average of 58.05 (SD+=9.36) days ranging from a minimum of 4 to a maximum of 98 days. Clinicians' assessment of the severity of illness showed that majority had shown improvement from their baseline clinical state with the use of Paliperidone ER. The proportion of severely ill had decreased by 15% while the proportion of those who were markedly ill had decreased by 15% while the proportion of those who where markedly ill had decreased by 35% by the end of the second visit. Overall, after eight weeks of paliperidone treatment, there was a decrease of 58% in the proportion of subjects evaluated to be mildly ill, borderline mentally ill and normal at the end of the second visit. This means that there was a marked improvement in patients observed and reported symptoms, behavior and functions as assessed by physicians using CGI. Fifteen percent of study participants experienced at least one non-serious adverse event during the study. The five most common non-serious adverse events observed include sleeplessness, extrapyramidal symptoms described as Pseudo parkinsonian tremors, stiffness of body and DOB/EPS reaction hand tremors, depression, akathisia and dizziness. CONCLUSION: Paliperidone ER administered at 6 mg single dose improved symtoms and clinical signs among adult Filipinos diagnosed with schizophrenia who are moderately and markedly ill. The drug is will-tolerated, but the dose may need to be increased for more severely ill patients. Paliperidone ER is one of the current useful options for the treatment of patients with schizophrenia.

Comparison of saccade, smooth pursuit and optokinetic nystagmus among Filipino patients diagnosed with schizophrenia, their siblings without schizophrenia and controls using the electronystagmogram: a pilot study at the Santo Tomas Hospital

Objectives: The structural abnormality implicated in schizophrenia was supported by eye movement abnormalities, which were considered biological or trait markers of this psychiatric disorder. We aimed to establish the presence of these changes in schizophrenia by comparing the smooth pursuit eye movement latency, fixed amplitude saccade latency and symmetry of optokinetic nystagmus using the electronystagmogram among Filipino patients diagnosed with schizophrenia, their siblings without schizophrenia and controls who were neither related to the patient nor diagnosed with schizophrenia. Methods: Included were twenty patients 18-40 years old diagnosed of schizophrenia based on the DSM-IV Criteria, their siblings and twenty controls. All subjects underwent electronystagmography at the Ear Center, University of Santo Tomas Hospital where the following were measured: fixed amplitude saccade latency; horizontal smooth pursuit latency and symmetry of optokinetic nystagmus. The values obtained were then analyzed using paired t-test and two way ANOVA. Results: There was a significant difference in the latency of the fixed amplitude saccade and horizontal smooth pursuit among the three groups. PAtients with schizophrenia had the most delayed latency followed by their siblings. No delay was noted in controls. Significant asymmetry of the optokinetic nystagmus in schizophrenic patients was noted. Abnormalities present in the healthy siblings of patients indicated their latent vulnerability towards this disease. Conclusion: The findings of the study further strengthened the anatomical substrate of schizophrenia. These eye movement abnormalities are localized in the parietal and frontal cortex. These are the same areas that are necessary for attentional symmetry, for minimizing distractibility and maintaining the focus of attention on task relevant stimuli which are impaired in patients with schizophrenia.

Awareness and confidence of family physicians in recognition and treatment of psychiatric illness

The family practitioner plays an important role in the detection and treatment of mental disorders. It is said that over half of all persons affected with mental illness are initially seen and treated by the non-psychiatrist in the outpatient setting rather than in the specialty mental health clinic. Objective: This paper aims to evaluate perceived level of confidence and competence of the primary care practitioner in the recognition, diagnosis, and management of mental disorders. Methods: A survey of family physicians and general practitioners using a thirteen (13)-point questionnaire during an annual convention of the Philippine Academy of Family Physicians (PAFP) was conducted. The questionnaire included items that attempted to quantify: exposure to psychiatry during residency and current medical practice; proportion of mental illness cases among total patient load; signs and symptoms that would be associated with mental illness; familiarity with standardized criteria for diagnosing mental illness i.e. schizophrenia and depression; familiarity with therapeutic medications; and perceived level of confidence in treating psychiatric cases. Results and Conclusion: The study implies that the family physician, although aware of the general signs and symptoms indicative of mental illness, is still hesitant in formulating a definitive diagnosis. Possible reasons for this attitude may be inadequate training in psychiatry as well as unfamiliarity and perceived difficulty with the DSM-IV.