Short-term remission in schizophrenia as a combination of several outcome measures☆
Introduction
The issues of remission and recovery in schizophrenia have received increasing attention in the last decade, offering new opportunities for clinical practice, health services research and clinical trials (Andreasen et al., 2005, van Os et al., 2006, Davidson et al., 2008, Rossi et al., 2009).
Pharmacotherapy for schizophrenia and related disorders is well established in clinical psychiatry and offers considerable benefit in controlling symptoms and preventing relapse (Lehman et al., 2004). Short-term efficacy and relapse-prevention studies have the value of establishing a quantitative aspect of pharmacotherapy related mainly to efficacy and safety (Kane et al., 2003, Honer et al., 2007).
In a previous study, Rossi et al. (2008) reported the results of an investigation on a total of 312 patients with schizophrenic disorder who were switched to an 8-week, open-label, flexible dose (40–160 mg/day) of Ziprasidone. Significant improvements from baseline to endpoint were reported for Positive and Negative Syndrome Scale scores, Clinical Global Impression Severity, Global Assessment of Functioning, Well-being under Neuroleptic scores, and Trail Making Test. Significant improvements were also found for mean Simpson–Angus scale score, sexual dysfunction, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides. In addition, mean bodyweight significantly decreased from baseline.
It is arguable that several variables, other than symptom assessment, could play a role in drug response and remission achievement (Davidson et al., 2008, Lambert et al., 2010, Clark et al., 2011, Oorschot et al., 2012).
In the current study we performed a post-hoc analysis, re-examining previous data in order to look at how these variables interact in determining short-term remission. With this aim we utilized the severity criteria of the original remission definition by Andreasen et al. (2005), omitting the temporal requirement because the 8-week study is too short to discern longer-term out-comes.
We planned a logistic stepwise regression model to explore how different kinds of variables (i.e. socio-demographic, cognitive functioning, laboratory metabolic and clinical parameters) could explain symptom remission (Gharabawi et al., 2006). The considered independent variables were not only baseline values of these variables but the variations from baseline to endpoint were also included in order to investigate how the modification during a trial could be associated with short-term remission as the primary outcome.
Section snippets
Subjects
The study group included 262 outpatients aged 18–60 years [155 men and 107 women; age (mean±S.D.) 38.19±9.66; age at onset 27.47±8.02] with diagnosed schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV). This sample was drawn from that enrolled in the Rossi et al. (2008) study including 312 patients, of whom 238 completed the 8-week trial. Twenty-four more patients who completed at least 6 weeks of treatment, and who attended the trial for an adequate
Results
The non-remission/remission state criteria divided the total sample into a group of 138 subjects not in remission at the end of the trial and 124 in a state of remission.
The first stepwise logistic regression reveals that the only significant predictors of the remission state are three variables: GAF, Negative and Positive PANSS basal scores that entered in the final equation, with the highest significance for GAF (Table 1). The classification table of observed vs. predicted cases shows the
Discussion
The basic idea was to explore variables other than symptoms possibly related to short-term remission in an 8-week Ziprasidone trial in schizophrenia.
The first logistic analysis reveals unsurprising results: the baseline variables that were entered in the model are related to symptomatology, i.e. negative and positive symptoms, and global functionality. This kind of approach can be considered quite naïve, because it is substantially affected by illness severity and functional status, defining
References (40)
- et al.
Analysis of efficacy and side effects in CATIE demonstrates drug responses subgroups and potential for personalized medicine
Schizophrenia Research
(2011) - et al.
Quality of life in patients who have remitted from their first episode of psychosis
Schizophrenia Research
(2010) - et al.
Metabolic-cognitive syndrome: a cross-talk between metabolic syndrome and Alzheimer's disease
Ageing Research Reviews
(2010) - et al.
Establishing remission and good clinical functioning in schizophrenia: predictors of best outcome with long-term risperidone long-acting injectable treatment
European Psychiatry
(2010) - et al.
Clinical global impression of improvement (CGI-I) as a valid proxy measure for remission in schizophrenia: analyses of ziprasidone clinical study data
Schizophrenia Research
(2011) - et al.
Mental slowness and executive dysfunction in patients with metabolic syndrome
Neuroscience Letters
(2009) Diagnostic and Statistical Manual of Mental Disorders, fourth edition: DSM-IV
(1994)- et al.
Remission in schizophrenia: proposed criteria and rationale for consensus
American Journal of Psychiatry
(2005) - et al.
Remission and recovery in schizophrenia: practitioner and patient perspectives
Schizophrenia Bulletin
(2008) - et al.
Changes in body weight and psychotropic drugs: a systematic synthesis of the literature
Plos one
(2012)
Obesity and hypertriglyceridemia produce cognitive impairment
Endocrinology
Reduction in psychotic symptoms as a predictor of patient satisfaction with antipsychotic medication in schizophrenia: data from a randomized double-blind trial
BMC Psychiatry
Association between metabolic syndrome and cognitive decline: a systematic review of prospective population based studies
Acta Neuropsychiatrica
Recovery from psychotic illness: a 15- and 25-year international follow-up study
British Journal of Psychiatry
Metabolic syndrome is associated with learning and recall impairment in middle age
Dementia and Geriatric Cognitive Disorders
A self-report scale predictive of drug compliance in schizophrenics: reliability and discriminative validity
Psychological Medicine
Conceptual and methodological issues in the design of clinical trials of antipsychotics for the treatment of schizophrenia
CNS Drugs
Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic
American Journal of Psychiatry
The positive and negative syndrome scale
Schizophrenia Bulletin
Prediction of remission as a combination of symptomatic and functional remission and adequate subjective well-being in 2960 patients with schizophrenia
Journal of Clinical Psychiatry
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The authors report no financial relationships with commercial interests.