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Objective: This pilot, twelve-week, open-label study examined the effect of clozapine orally disintegrating tablet or ODT in patients with schizophrenia and schizoaffective disorder utilizing Positive and Negative Syndrome Scale PANSS as a long-term outcome measurement tool. Methods: The final study sample consisted of nineteen subjects who were residents a long-term care psychiatric facility in Pomona, California.
PANSS were administered at baseline, week-4, week-8 and week Paired sample t-tests were used to calculate the statistical significance of the mean differences for scores at baseline and week Results: Mean differences from baseline indicated significant improvement on total score, as well as positive, negative, cognitive and general psychopathology subscales after twelve weeks of treatment. The greater average reduction in the negative syndrome subscale across the twelve weeks possibly illustrates the ability of clozapine ODT in improving negative symptoms, including cognitive function which is their ability to participate in their personal care and creative expressions in dance, arts, games, poetry to a greater extent their overall, quality of life and living along with the effect on positive symptoms.
Conclusion: Overall, clozapine proved to affect a broad range of psychopathology including cognitive functions in this schizophrenic sample. Calidad de vida. Resultados del tratamiento.
Estados Unidos. Assistant Professor of Pharmacy Practice-Psychiatry. Carmen NATE. Clinical Assistant Professor of Psychiatry. Clozapine is the only atypical antipsychotic drug indicated for treatment-refractory schizophrenia based on its established superior efficacy. It is the only atypical antipsychotic that is approved for the reduction of suicidal behaviour.
Orally disintegrating tablets ODT of clozapine, offers a better way to increase adherence and improve control of psychotic symptoms. The Positive and Negative Syndrome Scale PANSS is an established psychiatric rating system that is an operationalized, drug-sensitive instrument that offers balanced representation of positive and negative symptoms and estimates their relationship to one another and to global or general psychopathology. In this study, PANSS is conducted on patients receiving clozapine ODT in a free-standing mental health facility to determine long term patient outcomes in cognition as related to creativity and quality of life.
Inclusion Criteria: Study subjects were selected by reviewing clients' medical charts in Olive Vista, a long-term care psychiatric facility, in Pomona, California. Clients were included in the study if they were on either on clozapine ODT or clozapine, and also have the following inclusion criteria: 1 diagnosis of schizophrenia or schizoaffective disorder diagnosed based on DSM-IV by the facility's psychiatrist; 2 have been placed on clozapine ODT by the facility's psychiatrist or had been on the study medication before coming to this facility due to refractory to previous antipsychotic medication treatments.
Subjects currently using other typical or atypical antipsychotic medications are not excluded. Exclusion Criteria: Clients allergic to clozapine ODT or clozapine, or intolerant to the study medications due to severe adverse drug reactions were excluded. The study received IRB approval; and informed consents were obtained from each of the study subjects. All subjects were on dosages of clozapine ODT that were titrated by the facility psychiatrist to achieve maximum clinical benefits not based on PANSS scores.
Other than encouraging the subjects in their creative expressions of music, art, drama, games, poetry, humor, ensure their need for medication compliance and their sense of spiritual value no treatment intervention was necessary to carry out the study except the allowance of dosage reduction of study medications in the event of adverse drug reaction.
Positive syndrome is composed of symptoms such as delusions, hallucinations and disorganized thinking. Negative syndrome is characterized by deficits in cognitive, affective, and social functions, including blunting of affect and passive withdrawal. General Psychopathology is composed of many deficits in cognition such as disorientation, poor attention, lack of insight and active social avoidance.
Each item on the PANSS is accompanied by a complete definition as well as thorough anchoring criteria for all 7 rating points. Based on the above scoring method, the least scores for the Positive and Negative subscales are 7 points each, and 16 points for the cognitive category; for a combined total of minimum 30 points. Most points for each category are 49, 49 and for Positive, Negative, and cognition, respectively; for a combined total of maximum points.
Subjects were interviewed by the facility's psychiatrist and Psychiatric pharmacist at baseline and every 4 weeks thereafter baseline, week-4, week-8 and week The interviewer asked questions pertaining to PANSS and also encouraged subjects to discuss their history, circumstances surrounding their hospitalization, their current life situation and their symptoms.
The objective of this process is to establish rapport and allow subjects to express areas of concern. During each clinical interview, subject's affective, motor, behavioral and cognitive functions were observed. Their ability to participate by empowering them through their creative expressions and their integrative and interactive functions were also directly observed by the interviewers. The duration of each clinical interview was minutes.
Their overall functioning in their creative, integrative and interactive expressions as an exclusive group in each separate sessions was 20 to 30 minutes The PANSS ratings are based on all information derived from the clinical interview, direct observation of the subjects and reports of primary care staff.
Each rating was assigned by first referring to the item definition to determine presence of a symptom. The severity of an item is then determined by deciding which anchoring point best described the subject's functioning, whether or not all components of the description are observed.
The highest applicable rating was always assigned even if the subject meets criteria for the lower rating as well. White blood cell WBC count with differential and absolute neutrophil count ANC are monitored weekly to avoid hematologic adverse reactions, such as agranulocytosis.
Paired sample t-tests were used to compare the total score improvement as well as score improvement in each of the three subscales positive, negative and general psychopathology at baseline and the end of weeks of treatment. Final sample consisted of nineteen males and one female at the beginning of the study. However only nineteen clients finished the week study March 27th, to June 19th, ; one male client was transferred to another psychiatric facility before the week-4 assessment period.
Final assessment thus only included data for 19 subjects who finished the study. Mean age of Other concurrent antipsychotic medications include ziprasidone, quetiapine, risperidone, olanzapine, aripiprazole, haloperidol, and chlorpromazine. None of the subject experienced agranulocytosis during the 6-week study period. One subject developed seizure during week-8 resulted in the dose reduction of study medication from mg to mg daily. Paired sample t-tests showed statistically significant differences in all three scales and the total score between baseline and at week-6 Table 3.
Compared to baseline, at week, the average reduction in Positive scale was 4. Two subjects were discharged at week, and one subject was planning to be discharged shortly after reaching acceptable, stable clinical improvement. The results of the initial part of a longer study showed a statistical significant improvement in all three areas of PANSS at the end of week when compared to baseline.
On average, scores in all three areas positive, negative and cognitive progressively improved over the week study period. A greater improvement in negative scale compared to the positive scale was observed during the 6-week study period This observation concurs with the current understanding of the clinical benefit of clozapine and other atypical antipsychotics, that in addition to improving positive and negative symptoms of schizophrenia ex: delusion, hallucination, paranoia, etc.
The greater improvement in negative symptoms, including cognitive functions, observed in this study is in accordance with results of some previous studies. A study done on subjects with schizophrenia or schizoaffective disorder by Volavka et al 5 in comparing clozapine, olanzapine, risperidone and haloperidol showed that clozapine was the most effective treatment for negative symptoms.
Lindemayer et al 4 showed improvement in all three categories of PANSS in weeks treatment period in treatment-refractory schizophrenics with significant negative symptoms while on clozapine. The study did not exclude subjects who were on other antipsychotic medications in addition to clozapine ODT ; the effect of other concurrent antipsychotic medications could have compounded the results of the study.
However, it is a common, clinical practice for patients with schizophrenia or schizoaffective disorder to be on more than one antipsychotic. Clozapine usually is added as a last option to control psychotic symptoms or negative symptoms. Clinical relevance and importance of current study: Unlike previous studies, clozapine ODT is used in here.
Clozapine is typically used for refractory schizophrenia or schizoaffective disorder after other atypical antipsychotics, so its clinical effect on positive and negative symptoms, including cognition, is emphasized in the study. Primary measure of efficacy is the improvement in total PANSS score after twelve weeks of clozapine ODT treatment, including total score, as well as positive, negative and cognition or general psychopathology subscales in the study.
The present study used PANSS as an outcome measuring tool to evaluate the effect of clozapine ODT in patients with schizophrenia and schizoaffective disorder. The results of the week preliminary study period showed statistically significant improvement in total score as well as in positive, negative and general psychopathology scales. The statistically significant improvement in PANSS further validates the clinical benefit of clozapine in treating refractory schizophrenia.
Clozapine is typically reserved as treatment resistant schizophrenia due its potential risk of inducing agranulocytosis, so patients usually are given clozapine after they have only responded minimally to other antipsychotics. The promising results of the study confer hope to those refractory-schizophrenic patients and their families, in that, clozapine can help to improve positive and negative symptoms, and more importantly, cognition creativity and expression. With improved cognition, patients can function more normally and more independently in society.
Cheryl Eakin for their grant for this study. References 1. Alamo Pharmaceuticals. Schizophrenia Bulletin ; Clozapine effects on Positive and Negative Symptoms: A six-month trial in treatment-refractory schizophrenics.
J Clin Psychopharmacol ; Clozapine, olanzapine, risperidone, and haloperidol in the treatment of patients with chronic schizophrenia and schizoaffective disorder. Am J Psychiatry ; Servicios Personalizados Revista. Key words : Antipsychotic Agents. Quality of Life. Treatment Outcome. United States.
Escala das Síndromes Negativa e Positiva - PANSS e seu uso no Brasil
Positive and Negative Syndrome Scale
It is widely used in the study of antipsychotic therapy. The scale is known as the "golden standard" that all assessments of psychotic behavioral disorders should follow. The name refers to the two types of symptoms in schizophrenia, as defined by the American Psychiatric Association : positive symptoms, which refer to an excess or distortion of normal functions e. Some of these functions which may be lost include normal thoughts, actions, ability to tell fantasies from reality, and the ability to properly express emotions. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. As 1 rather than 0 is given as the lowest score for each item, a patient can not score lower than 30 for the total PANSS score.