Disorders - Psychosis Disorders
Ventura, J., McEwen, S., Subotnik, K., Hellemann, G., Nuechterlein, K.
Background: Meta-analyses have shown that various forms of exercise in schizophrenia patients are associated with symptom reduction, improved quality of life, and increased levels of functioning. We examined whether combining cognitive training and aerobic exercise could improve symp-toms and social functioning in frst episode schizophrenia patients more effectively than cognitive training alone. Some evidence would indicate that intervening during this early phase of psychosis might be especially benef-cial for maximizing treatment effects. Methods: In this RCT, 46 patients with a frst episode of schizophrenia were assigned to Cognitive Training plus Exercise (CT&E: n = 23) or Cognitive Training alone (CT; n = 23) for 6 months. Both groups received 24 weeks of cognitive training, 4 hours per week. The CT&E group, in addition to CT, participated in aerobic exercise, 150 minutes per week. The frst 12 weeks involved neurocognitive training (BrainHQ). The second 12 weeks involved social cognitive training (SocialVille). The aerobic conditioning exercises included 45 minutes at UCLA two days a week and 30 minutes at home two days a week. Intensity of aerobic exercise was tailored to maintain an individualized target heart rate zone. A weekly one-hour Bridging Skills Group was used to aid generalization of training to everyday life situations. Negative symptoms were assessed every two weeks with the BPRS and every 3 months with the SANS. The Global Functioning Scale: Social was rated every 3 months. Results: A Generalized Linear Mixed Model (GLMM) was used to compare the trajectories of changes in negative symptoms and social functioning. Analysis of the BPRS negative symptoms indicated that a signifcantly larger decrease in expressive negative symptoms occurred for patients in CT&E vs CT alone (F(1, 376) = 4.9, P =.03). SANS Blunted Affect also showed a differential decrease over time favoring CT&E (F(1, 30) = 4.1, P =.05). The SANS Avolition-Apathy domain also showed a differential effect of treatment favoring CT&E (F(1, 33) = 7.6, P =.01). Analysis of GFS Social showed a statistically signifcant difference in the trajectories of the two groups, again favoring CT&E (F(1, 38) = 4.1, P =.05). Conclusion: Our preliminary fndings support the use of exercise to boost the effects of cognitive training for reducing negative symptoms and improving social functioning. In particular, we found signifcant differential reductions on the BPRS negative symptom factor and on SANS Blunted Affect and Avolition/Apathy. The enhancing effect of adding exercise to cognitive training appears to extend the benefcial effects beyond cognitive gains alone. Promoting exercise interventions in frst episode patients might lead to early gains that could promote recovery.
Schizophrenia Bulletin, 43(Suppl 1) : S52
- Year: 2017
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: First episode (psychosis only)
-
Treatment and intervention: Complementary & Alternative Interventions (CAM)
, Psychological Interventions (any)
, Cognitive remediation therapy, Physical activity, exercise
Ventura, J., Subotnik, K. L., Gretchen-Doorly, D., Casaus, L., Boucher, M., Hellemann, G. S., Nuechterlein, K. H.
BACKGROUND: Meta-analyses have reported that the effects of cognitive remediation might go beyond improvement in cognition to include unexpected benefits for schizophrenia patients such as negative symptom reduction and improvements in functioning. In addition, some evidence indicated that these potentially beneficial effects are also present in the initial course of schizophrenia, but work in this area is still developing.
METHOD: A RCT compared Cognitive Remediation (CR) to Healthy Behaviors Training (HBT) in 80 patients (78% male) with a mean age of 21.9years and mean education of 12.3years who had a first psychotic episode within two years of study entry. Participants were trained using CR programs or received HBT involving 50 sessions over 6months and then booster sessions over the next 6months. The SANS and BPRS were used to assess symptoms. The UCLA Social Attainment Survey assessed social functioning.
RESULTS: Using GLMM, improvements over 12months were found favoring CR for SANS Expressive Symptoms (p<0.01), which was composed of Affective Flattening (p<0.01) and Alogia (p=0.04), and for SANS Experiential Symptoms, composed of Avolition/Apathy (p=0.04) and Anhedonia/Asociality (p<0.01). CR was associated with improvements in social functioning (p=0.05) as compared to HBT.
CONCLUSIONS: We confirmed that the beneficial effects of CR appear to extend beyond cognition to improvements in negative symptoms and social functioning in early course schizophrenia patients. These results suggest that cognitive remediation might have an impact when the reduction of risk factors for chronicity is most critical for promoting recovery.
Schizophrenia Research, 08 : 08
- Year: 2017
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: First episode (psychosis only)
-
Treatment and intervention: Psychological Interventions (any)
, Cognitive remediation therapy, Other Psychological Interventions
Vohs, J. L., Leonhardt, B. L., James, A. V., Francis, M. M., Breier, A., Mehdiyoun, N., Visco, A. C., Lysaker, P. H.
Poor insight impedes treatment in early phase psychosis (EPP). This manuscript outlines preliminary findings of an investigation of the novel metacognitively oriented integrative psychotherapy, Metacognitive Reflection and Insight Therapy, for individuals with early phase psychosis (MERIT-EP). Twenty adults with EPP and poor insight were randomized to either six months of MERIT-EP or treatment as usual (TAU). Therapists were trained and therapy was successfully delivered under routine, outpatient conditions. Insight, assessed before and after treatment, revealed significant improvement for the MERIT-EP, but not TAU, group. These results suggest MERIT-EP is feasible to deliver, accepted by patients, and leads to clinically significant improvements in insight.
Schizophrenia Research, 03 : 03
- Year: 2017
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions (any)
, Other Psychological Interventions
Wang, C., Shi, W., Huang, C., Zhu, J., Huang, W., Chen, G.
Background: Differences in effectiveness and tolerability between different atypical antipsychotics may affect schizophrenic patients' treatment adherence or prognosis. However, which kind of antipsychotic was more effective and safe in the treatment of schizophrenia is still being debated. This study attempted to understand whether there are any differences in efficacy, acceptability, and safety between the five atypical antipsychotics in patients with first-episode schizophrenia. Methods: Two hundred cases of inpatients with first-episode drug-naive schizophrenia were randomly assigned to 6-8 weeks of treatment with either of aripiprazole, risperidone, quetiapine, olanzapine, or ziprasidone from October 2012 to November 2014. The efficacy, acceptability, and safety measurement after 6-8 weeks of treatment of the five kinds of antipsychotics were evaluated by the deduction rate of Brief Psychiatric Rating Scale (BPRS) total score, the proportion of treatment discontinuation, and adverse events, respectively. Whether the treatment discontinuation or combination therapy for baseline antipsychotics after titration mainly depended on ineffective or less effective on an initial-assigned antipsychotic during the study period. Results: BPRS total scores in each antipsychotic group were significantly decreased at the end of the study (P < 0.01), and only the deduction rate of BPRS total scores in the risperidone group was markedly higher than those in the groups of aripiprazole (P < 0.01) and olanzapine (P < 0.05) after controlling the impact of the differences of age of onset. There were significant differences between quetiapine (chi 2 = 5.46, P = 0.019), olanzapine (chi 2 = 5.6, P = 0.018), and ziprasidone regarding the proportion of maintaining on initially allocated therapy. In addition, the difference in treatment discontinuation between male and female patients was also significant (chi 2 = 9.897, P = 0.002), and odds ratio of treatment discontinuation in male and female patients was 0.37 (95% CI 0.198-0.693); however, no difference in treatment discontinuation was found between five antipsychotics. Extrapyramidal symptoms in the groups of quetiapine and olanzapine were notably less than the other three kinds of antipsychotics (P < 0.05), but there were no significant differences in other adverse events between the five antipsychotic groups. Conclusions: Risperidone was more effective than aripiprazole and olanzapine in treating first-episode schizophrenia. The present study revealed the superiority of quetiapine and olanzapine over ziprasidone with remarkably less severe extrapyramidal adverse effects, especially with lower drop-out and treatment discontinuation. There were no differences in terms of other adverse events although the risk of treatment discontinuation was higher in female patients. Trial registration 2012-3-88. Registered 20 July 2012 Copyright © 2017 The Author(s).
Annals of General Psychiatry, 16(47) :
- Year: 2017
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: First episode (psychosis only)
-
Treatment and intervention: Biological Interventions (any)
, Atypical Antipsychotics (second generation)
Woods, S., Saksa, J., Compton, M., Daley, M., Rajarethinam, R., Graham, K., Breitborde, N., Cahill, J., Srihari, V., Perkins, D., Bearden, C., Cannon, T., Walker, E., McGlashan, T.
Background: Treatment guidelines for the clinical high risk (CHR) syndrome for psychosis currently recommend psychotherapies such as cognitive behavior therapy and focused family therapy as frst line treatment. Antipsychotic medications are generally discouraged for routine use, partly because of concern for adverse effects and partly due to a paucity of effcacy data, although some guidelines recommend them for more severe cases. The current study evaluated the safety and effcacy of ziprasidone in delaying or preventing conversion to psychosis among individuals meeting CHR syndrome criteria. Methods: Eligible subjects were treatment-seeking individuals 16 to 40 years old who met diagnostic criteria for CHR according to the Structured Interview for Psychosis-risk Syndromes. Exclusions were (1) use of antipsychotic med-ication in the previous 3 months, (2) initiation or increase in dosage of an antidepressant within 6 weeks, or (3) medical contraindications to taking ziprasidone (QTcF>=450 msec at screening or baseline, history of arrhythmia or QTc prolongation or syncope, family history of QTc prolongation, current receipt of medication known to prolong QTc, or K+, Mg++, or Ca++ below the normal range). Randomized subjects received ziprasidone 20-160 mg/d vs matching placebo for 24 weeks in two divided doses with meals. In addition, each subject was offered a Supportive Interpersonal Therapy session at each visit. Target enrollment was 80. Analyses were conducted in SPSS 21. Results: Six sites randomized 51 subjects, 27 to placebo, and 24 to zipra-sidone. One ziprasidone case was never dispensed medication and was removed from analysis. Two conversions were identifed in the placebo group and one in the active group; Cox regression showed no signifcant effect. Mixed regression on the SOPS positive symptom subscale with slope and intercept each modeled as random effects revealed a signifcant difference favoring ziprasidone (F = 6.64, df = 1.21, P =.017, slope difference-0.19 points per week, 95% CI-0.35 to-0.04). Two patients met QTcF criteria for safety withdrawal; both were assigned to placebo. Maximum QTcF across follow-up (placebo mean 407 msec, ziprasidone mean 403 msec) did not differ signifcantly. Mixed regression on weight measurements revealed no signifcant treatment effect (F = 0.22, df = 1.37, P = 0.645, slope difference-0.05 pounds per week, 95% CI-0.29 to 0.18). Conclusion: The primary outcome was not met, in part because the study did not meet its enrollment target and was consequently underpowered. The signifcant drug effect on attenuated positive symptoms provides some evidence for effcacy of ziprasidone in CHR syndrome. Together with the lack of QTc prolongation or signifcant weight gain in this study, the current evidence of effcacy supports consideration of ziprasidone when an antipsychotic is selected for clinical use in CHR syndrome.
Schizophrenia Bulletin, 43(Suppl 1) : S58
- Year: 2017
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Biological Interventions (any)
, Atypical Antipsychotics (second generation)
, Psychological Interventions (any)
, Interpersonal therapy (IPT)
, Supportive therapy
Tor, J., Dolz, M., Sintes, A., Munoz, D., Pardo, M., de-la-Serna, E., Puig, O., Sugranyes, G., Baeza, I.
The concept of being at risk for psychosis has been introduced both for adults and children and adolescents, but fewer studies have been conducted in the latter population. The aim of this study is to systematically review the articles associated with clinical description, interventions, outcome and other areas in children and adolescents at risk for psychosis. We searched in MEDLINE/PubMed and PsycINFO databases for articles published up to 30/06/16. Reviewed articles were prospective studies; written in English; original articles with Clinical High Risk (CHR) for psychosis samples; and mean age of samples younger than 18 years. From 103 studies initially selected, 48 met inclusion criteria and were systematically reviewed. Studies show that CHR children and adolescents present several clinical characteristics at baseline, with most attenuated positive-symptom inclusion criteria observed, reporting mostly perceptual abnormalities and suspiciousness, and presenting comorbid conditions such as depressive and anxiety disorders. CHR children and adolescents show lower general intelligence and no structural brain changes compared with controls. Original articles reviewed show rates of conversion to psychosis between 17 and 20% at 1 year follow-up and between 7 and 21% at 2 years. While 36% of patients recovered from their CHR status at 6-year follow-up, 40% still met CHR criteria. Studies in children and adolescents with CHR were conducted with different methodologies, assessments tools and small samples. It is important to conduct studies on psychopharmacological and psychological treatment, as well as replication of the few studies found. Copyright © 2017 Springer-Verlag GmbH Germany
European Child and Adolescent Psychiatry, : 1-18
- Year: 2017
- Problem: Psychosis Disorders
- Type: Systematic reviews
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Biological Interventions (any)
, Psychological Interventions (any)
Veerman, S. R. T., Schulte, P. F. J., de-Haan, L.
Negative symptoms (such as amotivation and diminished expression) associated with schizophrenia are a major health concern. Adequate treatment would mean important progress with respect to quality of life and participation in society. Distinguishing primary from secondary negative symptoms may inform treatment options. Primary negative symptoms are part of schizophrenia. Well-known sources of secondary negative symptoms are psychotic symptoms, disorganisation, anxiety, depression, chronic abuse of illicit drugs and alcohol, an overly high dosage of antipsychotic medication, social deprivation, lack of stimulation and hospitalisation. We present an overview of reviews and meta-analyses of double-blind, controlled randomised trials, in which the efficacy of pharmacological and non-pharmacological interventions for negative symptoms was assessed. Unfortunately, there have been very few clinical trials focusing on primary negative symptoms and selecting chronically ill patients with predominant persistent negative symptoms. An important limitation in many of these studies is the failure to adequately control for potential sources of secondary negative symptoms. At present, there is no convincing evidence regarding efficacy for any treatment of predominant persistent primary negative symptoms. However, for several interventions there is short-term evidence of efficacy for negative symptoms. This evidence has mainly been obtained from studies in chronically ill patients with residual symptoms and studies with a heterogeneous study population of patients in both the acute and chronic phase. Unfortunately, reliable information regarding the distinction between primary and secondary negative symptoms is lacking. Currently, early treatment of psychosis, add-on therapy with aripiprazole, antidepressants or topiramate, music therapy and exercise have been found to be useful for unspecified negative symptoms. These interventions can be considered carefully in a shared decision-making process with patients, and are promising enough to be examined in large, well-designed long-term studies focusing on primary negative symptoms. Future research should be aimed at potential therapeutic interventions for primary negative symptoms since there is a lack of research in this field.
Drugs, 77(13) : 1423-1459
- Year: 2017
- Problem: Psychosis Disorders
- Type: Systematic reviews
-
Stage: First episode (psychosis only)
-
Treatment and intervention: Biological Interventions (any)
, Service Delivery & Improvement, Psychological Interventions (any)
Rosenheck, R., Mueser, K. T., Sint, K., Lin, H., Lynde, D. W., Glynn, S. M., Robinson, D. G., Schooler, N. R., l Marcy, P., Mohamed, S., Kane, J. M.
Background: Participation in work and school are central objectives for first episode psychosis (FEP) programs, but evidence effectiveness has been mixed in studies not focused exclusively on supported employment and education (SEE). Requirements for current motivation to work or go to school limit the generalizability of such studies. Methods: FEP participants (N = 404) at thirty-four community treatment clinics participated in a cluster randomized trial that compared usual Community Care (CC) to NAVIGATE, a comprehensive, team-based treatment program that included >=5h of SEE services per week, , grounded in many of the principles of the Individual Placement and Support model of supported employment combined with supported education services. All study participants were offered SEE regardless of their initial interest in work or school. Monthly assessments over 24 months recorded days of employment and attendance at school, days of participation in SEE, and both employment and public support income (including disability income). General Estimation Equation models were used to compare CC and NAVIGATE on work and school participation, employment and public support income, and the mediating effect of receiving >=3 SEE visits on these outcomes. Results: NAVIGATE treatment was associated with a greater increase in participation in work or school (p = 0.0486) and this difference appeared to be mediated by SEE. No group differences were observed in earnings or public support payments. Conclusion: A comprehensive, team-based FEP treatment approach was associated with greater improvement in work or school participation, and this effect appears to be mediated, in part, by participation in SEE. (PsycINFO Database Record (c) 2017 APA, all rights reserved)
Schizophrenia Research, 182 : 120-128
- Year: 2017
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: First episode (psychosis only)
-
Treatment and intervention: Service Delivery & Improvement, Individual placement and support (IPS), vocational interventions
, Other service delivery and improvement interventions
Shi, J., Wang, L., Yao, Y., Zhan, C., Su, N., Zhao, X.
Psychosocial intervention trials for youth at clinical high risk (CHR) for psychosis have shown promising effects on treating psychotic symptoms but have not focused on psychosocial functional outcomes, and those studies have been conducted among help-seeking patients; there is a lack of research on non-clinical young CHR individuals. Systemic therapy (ST) is grounded in systemic-constructivist and psychosocial resilience theories. It has a number of advantages that makes it attractive for use with CHR individuals in non-clinical context. The present study evaluated the effect of ST for students at CHR on reducing symptoms and enhancing psychosocial function. This was a single-blind randomized controlled trial for CHR young people comparing ST to supportive therapy with a 6-month treatment. Psychotic and depressive symptoms (DS) as well as self-esteem and social support (SS) were assessed at pre- and posttreatment. 26 CHR individuals were randomly divided into intervention group (n = 13) and control group (n = 13). There were no significant differences in severity of symptoms, level of SS and self-esteem at baseline between the two groups (P > 0.05). At posttreatment, significant improvements in positive and DS as well as SS and self-esteem were observed in the ST group (P < 0.05); in the control group, these improvements were not significant (P > 0.05). The findings indicated that systemic intervention for university students at CHR for psychosis may have a positive effect on symptoms and self-esteem as well as SS in short term. More long-term research is needed to further evaluate this intervention. Copyright © 2017 Shi, Wang, Yao, Zhan, Su and Zhao.
Frontiers in Psychiatry, 8 (OCT)(211) :
- Year: 2017
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Psychological Interventions (any)
, Family therapy
Shuib, N., Ahmad, M., Mohamad-Alwi, M. N., Jamil-Osman, Z., Nik-Jaafar, N. R.
Objective: Studies towards recovery in the area of psychosis through Cognitive Remediation (CR) is paramount to improve cognition and psychosocial by concentrating the core deficit. The aim of the study was to evaluate the feasibility of CR by targeting lower-level cognitive process of processing speed (PS) in CR with metacognitive strategies to enhance the global cognition and functional outcomes. Methods: This parallel single blinded with two-arm trial involved 30 participants with First Episode Psychosis (FEP) from Klang Valley, Malaysia which successfully underwent 15 session- Remediation of Mind (ReMind) programme through web based cognitive training for eight week. The effect of adding PS in CR in treatment group (n = 15) were compared to standard care of CR (n = 15). The effects of 10-h targeted skill in PS were examined in this metacognitivebased CR. The neurocognition, psychopathology, and functional measures were assessed as pre and post assessment comprising The Brief Assessment of Cognition Schizophrenia Malay Version (BACSM), the Positive and Negative Syndrome Scale (PANSS), Schizophrenia Cognition Rating Scale (SCoRS), Social Functioning Scale (SFS), and Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4). Results: Results suggest that participants have benefit from recovery process in terms of their global cognition, symptoms reduction and real world functioning through progressive trend of enhancement. Conclusion: Targeted core feature of processing speed in CR was feasible and has a vast potential to be implemented in Malaysia for metacognitive competencies, cognitive performance and functional outcomes.
European Archives of Psychiatry and Clinical Neuroscience, 267(1 (Suppl 1)) : S53
- Year: 2017
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: First episode (psychosis only)
-
Treatment and intervention: Psychological Interventions (any)
, Cognitive remediation therapy
Schooler, N., Khan, A., Keefe, R., Marcy, P., Robinson, D., Kane, J.
Background: Significant cognitive impairment is already seen in first episode psychosis (FEP) and the degree of cognitive impairment is recognized as an important moderator of long-term outcomes. An important question is whether specialized FEP treatment can improve cognitive functioning, which has been relatively resistant to change. The NIMH sponsored RAISE-ETP study provided an opportunity to compare NAVIGATE, a coordinated specialty care intervention designed for FEP, to Community Care in a randomized clinical trial. Methods: The radnomized clinical trial (RCT) was conducted at thirty-four sites in the US. Seventeen sites were randomly assigned to provide NAVIGATE and 17 to provide Community Care. Four hundred four consenting participants who were 15 to 45 years old, were experiencing a first episode of psychosis and had not received more than 6 months of antipsychotic medication entered the study. Treatment and assessment continued for up to two years. The Brief Assessment of Cognition in Schizophrenia (BACS) was administered by trained on-site research assistants at baseline, one and two years. Age and sex adjusted T-scores for the BACS Composite and six sub-tests (Verbal Memory, Digit Sequencing, Verbal Fluency, Token Motor, Symbol Coding and Tower of London) were calculated at baseline, month 12 and 24. Generalized estimating equations (GEEs) were applied to compare interventions with respect to changes in cognition between baseline and months 12 and 24 and adjusting for within and between site variation. Results: The NAVIGATE and Community Care groups included 221 and 181 participants, respectively of the 223 and 181 in the study. At Month 12, 62.7% of the baseline sample completed the BACS, and at Month 24, 43.8% of the baseline sample did so. The GEE models showed significant interaction effects. The interaction between Group and Visit was a statistically significant predictor of change in: Verbal Memory, Verbal Fluency, Symbol Coding, Tower of London and the Cognitive composite (po 0.001 for all subtests). Further examination of the parameter estimates showed that for the NAVIGATE group, there was significant improvement at Month 12 and Month 24 for Verbal Memory (p = 0.002, p = 0.003, respectively), Digit Sequencing (p = 0.012, p = 0.020, respectively), Tower of London (p = 0.001, p = 0.002, respectively) and the Cognitive Composite (p = 0.001,p<0.001, respectively). For the Community Care group, there was a significant improvement at Month 12 and Month 24 for the Cognitive Composite (p = 0.036, p = 0.20, respectively); only the Tower of London showed significant difference from Baseline to Month 24 for the Community Care group (p<0.001). Conclusions: The results of this analysis suggest that NAVIGATE resulted in greater improvement in cognitive functioning in both an overall score and for specific components than did Community Care. NAVIGATE is a multi-component intervention; each intervention was guided by a manual and supervision by a central team. NAVIGATE includes psychopharmacological treatment with antipsychotics and other psychotropic medications using an internet based decision support system, an individual psychotherapy called Individual Resiliency Training, family psychoeducation and supported employment and education. The role of individual components cannot be readily determined and further analyses will evaluate the effect of moderator variables such as duration of untreated psychosis. To date, pharmacologic treatments to improve cognition have not demonstrated efficacy. Cognitive remediation strategies, notably Cognitive Enhancement Therapy pioneered by Gerard Hogarty, has shown efficacy in FEP patients but to the best of our knowledge, this is the first RCT to show an effect of a broad FEP focused intervention on cognitive functioning.
Neuropsychopharmacology, 41((Suppl 1)) : S593
- Year: 2016
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: First episode (psychosis only)
-
Treatment and intervention: Service Delivery & Improvement, Other service delivery and improvement interventions
Sahni, S., Chavan, B. S., Sidana, A., Kalra, P., Kaur, G.
BACKGROUND & OBJECTIVES: Clozapine may be more useful in treatment-naive patients with first-episode schizophrenia for better symptoms control and improving quality of life. The current study was carried out to compare the efficacy and tolerability of clozapine versus risperidone in treatment-naive, first-episode patients of schizophrenia.
METHODS: This was a comparative, open-label, six months prospective study of treatment-naive, first-episode patients with schizophrenia between the age group of 18 and 40 yr diagnosed as per the International Classification of Diseases-10 (ICD-10) criteria. A total of 63 patients were recruited and randomly assigned to clozapine group or risperidone group using computer-generated random number tables. Eight patients were lost to follow up. The dosages of the respective drugs were kept in therapeutic range of 200-600 mg/day and 4-8 mg/day orally for clozapine and risperidone, respectively.
RESULTS: On general psychopathology score, after six months of intervention, clozapine led to 60.32 per cent mean reduction in Positive and Negative Syndrome Scale (PANSS) for Schizophrenia total score while risperidone led to 56.35 per cent mean reduction in PANSS total score, which meant more improvement with clozapine. Clozapine group was found to have significant improvement in quality of life (P = 0.04339). On Glasgow Antipsychotic Side-effect Scale, clozapine was superior to risperidone. The most common side effects observed in clozapine group were oversedation (78.96%) and dizziness (55.23%), and in risperidone group, common side effects were rigidity (62.36%), sedation (38.69%), tremors (65.69%) and menstrual irregularities in 80.25 per cent of female patients.
INTERPRETATION & CONCLUSIONS: The findings of this preliminary study showed clozapine as a better choice than risperidone in terms of efficacy, tolerability and better quality of life in treatment-naive, first-episode schizophrenia. However, further studies need to be done on a larger group of patients to confirm the findings.
Indian Journal of Medical Research, 144(5) : 697-703
- Year: 2016
- Problem: Psychosis Disorders
- Type: Randomised controlled trials
-
Stage: First episode (psychosis only)
-
Treatment and intervention: Biological Interventions (any)
, Atypical Antipsychotics (second generation)