Schizophrenia Clinical Trial
Official title:
Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: a Randomized Comparison of Aripiprazole, Quetiapine and Ziprasidone Over 1 Year
Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive deficits are already present at the first break of the illness, seem to remain stable during early phases and noticeably influence daily functioning. Differences among antipsychotics in terms of cognitive effectiveness have turned out to be a topic of increasing research interest. The initially postulated superior neurocognitive effectiveness of second-generation antipsychotics (SGAs) compared to first-generation antipsychotics (FGAs) is currently under debate. Long-term studies would be of great value to evaluate the differential benefits exerted by antipsychotic drugs on cognitive performance. The aim of this study is to investigate the cognitive effects of aripiprazole, quetiapine and ziprasidone in first-episode psychosis at 1 year.
Study setting and financial support: data for the present investigation were obtained from
an ongoing epidemiological and three-year longitudinal intervention program of first-episode
psychosis (PAFIP) conducted at the outpatient clinic and the inpatient unit at the
University Hospital Marqués de Valdecilla, Spain. Conforming to international standards for
research ethics, this program was approved by the local institutional review board. Patients
meeting inclusion criteria and their families provided written informed consent to be
included in the PAFIP. The Mental Health Services of Cantabria provided funding for
implementing the program. No pharmaceutical company supplied any financial support.
Study design: this is a prospective, randomized, flexible-dose, open-label study.
Investigators used a simple randomization procedure: a computer-generated randomization list
was drawn up by a statistician. Dose ranges were 5-30 mg/day Aripiprazole, 40-160 mg/day
Ziprasidone and 100-600 mg/day Quetiapine. Rapid titration schedule (5-day), until optimal
dose was reached, was as a rule used unless severe side effects occur. At the treating
physician's discretion, the dose and type of antipsychotic medication could be changed based
on clinical efficacy and the profile of side effects during the follow-up period.
Antimuscarinic medication, Lormetazepam and Clonazepam were permitted for clinical reasons.
No antimuscarinic agents were administered prophylactically. Antidepressants (Sertraline)
and mood stabilizers (lithium) were permitted if clinically needed.
Clinical assessment: the severity scale of the Clinical Global Impression (CGI) scale, the
Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Positive symptoms
(SAPS), the Scale for the Assessment of Negative symptoms (SANS), the Calgary Depression
Scale for Schizophrenia (CDSS) and the Young Mania Rating Scale (YMRS) were used to evaluate
symptomatology. To assess general adverse event experiences, the Scale of the Udvalg for
Kliniske Undersogelser (UKU), the Simpson-Angus Rating Scale (SARS) and the Barnes Akathisia
Scale (BAS) were used. The same trained psychiatrist (BC-F) completed all clinical
assessments. These clinical data are described at AZQ2005 study.
Neuropsychological assessment. Cognitive functioning was assessed in patients at 2 points:
baseline and 1 year after the initialization of antipsychotic treatment. The cognitive
assessment at baseline was carried out at 12 weeks after recruitment because this time is
considered optimal for patients' stabilization. The evaluation required approximately 2 h
and was carried out in the same day by the same neuropsychologist (R.A.-A and E.G.-R). The
neuropsychological battery comprises 9 cognitive domains: information processing speed,
motor dexterity, working memory, verbal learning, visuospatial abilities, delayed memory,
attention, executive function and theory of mind.
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