Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in Treatment of First Episode Psychosis: 3-year Follow-up
Information source: Fundación Marques de Valdecilla
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Psychotic Disorders
Intervention: Aripiprazole (Drug); Quetiapine (Drug); Ziprasidone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Fundación Marques de Valdecilla Official(s) and/or principal investigator(s): Benedicto Crespo-Facorro, Professor, Principal Investigator, Affiliation: University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Santander, Spain.
Summary
The selection of antipsychotic in early stages of the illness is mainly determined by its
clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug
treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a
homogeneous group and clinical effects and profile of side effects differ between SGAs.
Differences among antipsychotics in terms of effectiveness have turned out to be a topic of
increasing research interest, although comparisons between the different SGAs are scarce. In
first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to
first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less
evident seems to be the notion that some of the SGAs might be more effective (in terms of
treatment discontinuation) than others. Most of the medium-term randomized studies have
shown similar rates of all-cause treatment discontinuation in first episode patients treated
with different SGAs. It may be concluded that more randomized controlled trails should be
accomplished to determine the position of frequently used SGAs in clinical practice.
Investigators undertook this study with the major objective of comparing the clinical
effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in
the acute treatment of first-episode non-affective psychosis individuals at 3 years of
follow-up.
Clinical Details
Official title: Phase IV Study of Effectiveness of Aripiprazole, Quetiapine, and Ziprasidone in the Treatment of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program II (PAFIP II): a 3-year Follow-up
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effectiveness of antipsychotics (percentage of discontinuation of the initially assigned treatment)
Secondary outcome: Change in general psychopathology measured by the Brief Psychiatric Rating Scale (BPRS)Change in positive and negative symptoms measured by the Scale for the Assessment of Negative and Positive Symptoms (SANS and SAPS) Adherence to treatment measured by Morinsky questionnaire Functional outcome measured by Disability Assessment Scale (DAS) and Global Assessment Functioning (GAF).
Detailed description:
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. None pharmaceutical company supplied any financial support to it.
Study design: 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)
and the Scale for the Assessment of Negative symptoms (SANS) 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 to assess side effects. The adverse events were evaluated using the
UKU Side effect rating scale. Those treatment-emergent adverse events that occurred at a
rate of at least 10% in either treatment group are considered. Treatment-emergent akathisia
(BAS) and extrapyramidal symptoms (SARS) were assessed by both baseline-to-end changes and
newly emergent categorical changes. The same trained psychiatrist (BC-F) completed all
clinical assessments.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients followed in the First Episode Psychosis Clinical Program (PAFIP II) from
October 2005 to January 2011.
Exclusion Criteria:
- Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
(DSM-IV) criteria for drug dependence
- Meeting DSM-IV criteria for mental retardation
- Having a history of neurological disease or head injury.
Locations and Contacts
University Hospital Marqués de Valdecilla, Santander, Cantabria 39008, Spain
Additional Information
Starting date: October 2008
Last updated: August 14, 2015
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