The International Journal of Psychosocial Rehabilitation

Risperidone and Social Outcome in Schizophrenia:
A One Year Follow-up Study


Amresh Shrivastava1
Nilesh Shah2
Sushma Sonavane3
Avinash De Sousa4


1 Consultant Psychiatrist, University of Western Ontario, Lawson Health Research Institute, London, Canada.
2 Professor and Head
3 Professor
4 Research Associate
Department of Psychiatry, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.







Citation:
Shrivastava A, Shah N, Sonavane S, & DeSousa A (2014)  Risperidone and Social Outcome in Schizophrenia:
A One Year Follow-up Study
.  International Journal of Psychosocial Rehabilitation. Vol 18(2) 67-71




ADDRESS FOR CORRESPONDENCE -
Dr. Avinash De Sousa, Carmel, 18, St. Francis Road, Off S.V. Road, Santacruz West, Mumbai 400-054. Tel – 91-22-26460002. E-mail – avinashdes888@gmail.com



Abstract
Risperidone has been found to be effective in the management of schizophrenia across various studies. Most of these studies have looked at the clinical outcomes in patients with schizophrenia. The emphasis has always been on improvement in clinical features is usually primarily assessed by various rating scales. Most of these studies are of 8-12 weeks duration and report short-term outcomes. One should also assess the improvement on various psychosocial measures as clinical improvement may not give the clear picture of recovery. It is also important to look at the long-term outcome in schizoprenia. So the present study was envisaged with the intention to study the clinical as well psychosocial outcome at the end of one year in patients of schizophrenia on Risperidone. 50 consecutive patients of schizophrenia, diagnosed as per the DSM-IV criteria, fulfilling the selection criteria were followed-up and treated with Risperidone over a period of one year. Improvement was assessed using Positive and Negative Symptom Scale (PANSS), Clinical Global Improvement – Severity (CGI-S) and seven psychosocial parameters viz. social functioning, productivity, economic independence, education, suicidality, re-hospitalization and exacerbation. Predefined operational criteria were used to rate the patients on these seven psychosocial parameters. A statistically significant improvement was noticed with Risperidone therapy on PANSS and CGIS at the end of study period of one year. This was associated with a clinically significant improvement on all the various psychosocial parameters. A significant improvement was observed on clinical as well as psychosocial parameters in the patients of schizophrenia over a period of one year with Risperidone therapy. 

Key words – Risperidone, social outcome, psychosocial, outcome.


Introduction
Many patients of schizophrenia may continue to have impairment in psychosocial and occupational functioning in spite of significant improvement in clinical features like delusions and hallucinations (Lin, Wood, & Young, 2013). Therefore, it has been emphasized that in order to get a comprehensive idea about improvement, one has to assess improvement in psychosocial and occupational functioning as well, along with clinical improvement, not only after a couple of months but over a long-term period (Fiszdon, & Reddy, 2012).

Risperidone is an atypical antipsychotic that has been widely in the management of patients with schizophrenia (Emsley, & Oosthuizen, 2004). Majority of the studies with Risperidone have looked at the short-term clinical outcome (Eberhard, Levander, & Lindstrom, 2009). Very few studies have evaluated the psychosocial outcome over long-term with Risperidone therapy in schizophrenia (Haro, & Salvador-Carulla, 2006). Hence, the present study was envisaged to study the psychosocial outcome along with clinical outcome in patients of schizophrenia at the end of 1 year with Risperidone treatment.

Methodology
The study was carried out in a tertiary centre for schizophrenia management. The potential candidates and their accompanying relatives attending the outpatient department of the center were explained the nature and purpose of this study. Those who expressed their willingness to participate in the study by signing the informed consent form were screened as per the following selection criteria. The following inclusion and exclusion criteria were used for the study.
Inclusion criteria :
1.    Patients of schizophrenia who fulfilled the DSM-IV criteria.

2.    Patients who were either drug nave or those who were on a single antipsychotic medication other than Risperidone but were unable to tolerate it.
Exclusion Criteria :

1.    Patients who have received Risperidone anytime in the past and have discontinued it due to lack of efficacy or side-effects. 
2.    Patients who had any other concomitant psychiatric disorder like substance use disorder which was likely to interfere with the study.
3.    Patients who had any other concomitant medical disorder like seizure disorder which was likely to interfere with the study.
4.    Patients who were pregnant, lactating or who were unwilling to use contraceptive measures during the study period.
5.    Patient who required intensive psychiatric intervention as they were either harmful to self or others.
6.    Patients who had received electroconvulsive therapy (ECT) in the past 3 months.

A total of 50 patients meeting the inclusion and exclusion criteria were selected for the study.
Patients who fulfilled the selection criteria were rated on the Positive and Negative Symptom Scale for Schizophrenia (PANSS) and on seven psychosocial outcome parameters (Social functioning, Productivity, Economic independence, Education, Suicidality, Rehospitalization, Exacerbation) using operational criteria and a lickert type rating from 0 to 4 as shown in Table 1. Please note that in the first 4 psychosocial parameters higher the score better the functioning, while in the last 3 parameters lower the score better the functioning.

Table 1 – Assessment of various psychosocial domains

 

          

               Scores

      Areas      

 

0

 

1

 

2

 

3

 

4

 

Social Functioning

 

Withdrawn

behavior

 

Expressed

desire of

interaction

.

Definitive

evidence

of improved

functioning

 

Improvement

in functioning

and relationship

 

Functioning with satisfaction

 

Productivity

 

Unproductive

 

Expression of productivity

 

Occasional Productivity

 

Productive with support

 

Productive without support

 

Economic Independence

 

Complete dependence

 

Desire to earn

 

Attempt with failure

 

Attempt with success

 

Satisfactorily independent

 

Education

 

Unable to resume

 

Feels confident but unable to start

 

Attempt but not sustained

 

Sustained without satisfaction

 

Sustained with satisfaction

 

Suicidality

 

No intent

 

Occasional death wish

 

Contemplating suicide

 

Experiencing suicidal crisis

 

Attempted suicide

 

Rehospitalization

 

Not required

 

Required unrelated to current illness

 

Required due to side effects

 

Required due to additional stress

 

Required due to relapse

 

Exacerbation

 

No exacerbation

 

Mild behavioral exacerbation

 

Moderate exacerbation

 

Severe exacerbation

 

Severe exacerbation with hospitalization

 

After the baseline rating on PANSS and on the above mentioned seven psychosocial parameters, patients were started on Risperidone (2 mg) at bed-time. Patients were asked to follow-up, initially every week for a period of 4 weeks during which dose of the medication was titrated up to 6-8 mg/day. Concomitant medication such as Trihexiphenydyl (4-6 mg/day) and Clonazepam (0.5 -2 mg/day) were added as and when required. Subsequently patients were followed-up on the monthly basis till the end of the study period of 1 year. During each follow-up visit, patients were asked to report any adverse event experienced by them. At the end of the study period of 1 year, patients were again rated on PANSS and above mentioned seven psychosocial parameters using same operational criteria.        

Results
There were an almost equal number of male and female subjects in the study. There were 34 males and 26 female patients. All 50 patients enrolled in the study completed the study with no drop outs. This was due to the fact the patient was paid a transport allowance for each visit to ensure compliance and a telephonic reminder of the visit was made. As is evident from Table 2, a statistically significant reduction was observed in the scores on all the four parameters on the PANSS scale suggesting a substantial clinical improvement in patients of schizophrenia with Risperidone over one year of treatment. On assessing the scores on the seven psychosocial parameters (Table 3), it was noted that Risperidone helped in improved in all areas of psychosocial functioning with over 62% of patients reporting improvement in social functioning, productivity, economic independence and education while over 82% patients showed an improvement in suicidality, risk of rehospitalization and acute exacerbation of symptoms. The adverse effect profile when monitored for Risperidone therapy was also favorable with weight gain (6%) and extrapyramidal symptoms (16%) being the commonest side effects reported.  Sexual side effects were reported with 12% patients while amenorrhea was reported by 6 of the female subjects.

Table 2 – Improvement on the PANSS scores over a one year period

 

PANSS

Mean (SD)

Baseline score

Mean (SD)

Score at 1 year

t value

p value

Positive symptoms score

30.4 (6.9)

17.5 (4.1)

11.3649

< 0.0001*

Negative symptoms score

24.5 (6.8)

13.7 (4.1)

10.776

< 0.0001*

General psychopathology score

49.5 (13.3)

32.1 (12.2)

6.8172

0.0001*

Total PANSS Score

104.6 (12.6)

64.3 (12.2)

16.2882

< 0.0001*

* significant

 

Table 3 – Improvement on various domains of psychosocial functioning

Psychosocial parameters

Number of patients rated as 0 or 1

Number of patients rated as 2, 3, or 4

 

Social Functioning

 

16 (32%)

 

34 (68%)

 

Productivity

 

15 (30%)

 

35 (70%)

 

Economic Independence

 

19 (38%)

 

31 (62%)

 

Education

 

10 (20%)

 

40 (80%)

 

Suicidality

 

45 (90%)

 

05 (10%)

 

Rehospitalization

 

44 (88%)

 

06 (12%)

 

Exacerbation

 

43 (86%)

 

07 (14%)

* In the first 4 psychosocial parameters higher the score better the functioning, while in the last 3 parameters lower the score better the functioning.
Discussion
Risperidone has been shown in research studies to have a good efficacy in the management of schizophrenia. The reduction in PANSS scores were in keeping with previous efficacy and clinical improvement studies of Risperidone (Ristner, Gibel, Perelroyzen, Kurs, Jabarin, & Ratner, 2004). A study that compared Risperidone to Olanzapine head on has also found that Risperidone has better efficacy that Olnazapine on psychosocial parameters (McGrath & Tempier, 2005). In another large study of 1029 subjects with schizophrenia and related disorders it was noted that most antipsychotics help in improving psychosocial outcome in schizophrenia though in early stage psychosis with results in chronic schizophrenia being unknown (Guo, Zhang, Zai, & Early Stage Schizophrenia Outcome Study Investigators, 2012).

It is also well known that no medication can alone improvement psychosocial functioning but needs to be coupled with social skills training, psychotherapy and family psychoeducation (Awad & Voruganti, 2004). Our study was a small circumscribed study limited to just 50 patients with schizophrenia and cannot be generalized to all settings. We need further studies that compare chronic and early stage schizophrenia, studies that compare various atypical antipsychotics and studies that combine various pharmacological and non pharmacological treatments to assess psychosocial function improvement in detail. This is however one of the few studies that looked at psychosocial functioning in seven domains and further longitudinal studies in larger number of subjects in various settings are warranted.


References
Awad, A.G., & Voruganti, L.N. (2004). Impact of atypical antipsychotics on quality of life in patients with schizophrenia. CNS Drugs, 18(13), 877-893.

Eberhard, J., Levander, S., & Lindstrom, E. (2009). Remission in schizophrenia : analysis in a naturalistic setting. Comprehensive Psychiatry, 50(3), 200-208.

Emsley, R., & Oosthuizen, P. (2004). Evidence based pharmacotherapy for schizophrenia. International Journal of Neuropsychopharmacology, 7(2), 219-238.

Fiszdon, J.M., & Reddy, L.F. (2012). Review of social cognitive treatments for psychosis. Clinical Psychology Review, 32(8), 724-740.

Guo, X., Zhnag, Z., Zhai, J., & Early stage Schizophrenia Outcome Study Investigators. (2012). Effects of antipsychotic medication on quality of life and psychosocial functioning in patients with early stage schizophrenia : a one year follow up naturalistic study. Comprehensive Psychiatry, 53(7), 1006-1012.

Haro, J.M., & Salvador-Carulla, L. (2006). The SOHO (Schizophrenia Outpatient Health Outcome) study : implications for the treatment of schizophrenia. CNS Drugs, 20(4), 293-301.

Lin, A., Wood, S.J., & Yung, A.R. (2013). Measuring psychosocial outcome is good. Current Opinion in Psychiatry, 26(2), 138-143.

Ritsner, M., Gibel, A., Perelroyzen, G., Kurs, R., Jabarin, M., & Ratner, Y. (2004). Quality of life outcomes of risperidone, olanzapine and typical antipsychotics among schizophrenia patients treated in routine clinical practice : a naturalistic comparative study. Journal of Clinical Psychopharmacology, 24(6), 582-591.

McGrath, B.M., & Tempier, R.P. (2005). Patients’ opinions about olanzapine and risperidone after long term treatment : results from a cross sectional survey. Pharmacopsychiatry 2005; 38(4): 147-157.



 


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