Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in Treatment of First Episode Psychosis: 3-year Follow-up (PAFIP2_3Y)
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|ClinicalTrials.gov Identifier: NCT02526030|
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Psychotic Disorders||Drug: Aripiprazole Drug: Quetiapine Drug: Ziprasidone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||June 2015|
Active Comparator: Aripiprazole
Oral, dose range 10-30 mg/day, once or twice a day, during study duration
Other Name: Abilify
Active Comparator: Quetiapine
Oral, dose range 100-600 mg/day, once or twice a day, during study duration
Other Name: Seroquel
Active Comparator: Ziprasidone
Oral, dose range 40-160 mg/day, once or twice a day, during study duration
Other Name: Zeldox
- Effectiveness of antipsychotics (percentage of discontinuation of the initially assigned treatment) [ Time Frame: 3 years ]
Two measures for evaluate the effectiveness of antipsychotics:
- Percentage of discontinuation of the initially assigned treatment: patients who completed the 3 years follow-up assessment and changed initial antipsychotic.
- Mean time to all-cause medication discontinuation.
Four reasons for the discontinuation were recorded: 1.- insufficient efficacy; 2.- marked side-effects; 3.- patient reported non-adherence and 4.- other causes. If more than one reason for discontinuation was present, the most important reason according to the above ranking was selected. Antipsychotic treatment data (doses, discontinuation and concomitant medications) were registered every 6 months. Insufficient efficacy was established at the treating physician's judgment only after at least three weeks of treatment.
- Change in general psychopathology measured by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 3 years ]Measured by BPRS.
- Change in positive and negative symptoms measured by the Scale for the Assessment of Negative and Positive Symptoms (SANS and SAPS) [ Time Frame: 3 years ]Measured by SANS and SAPS.
- Adherence to treatment measured by Morinsky questionnaire [ Time Frame: 3 years ]Adherence criteria for categorizing "good adherence category" using a 90% adherence as the cut-off will be set up as well based of infora. At study design we opted to set up stringent definition of "good adherence" because we were interested in differentiating individuals who really were good adherent and those with irregular taking to thoroughly investigate the impact of medication in illness outcome and biological parameters. Our results seem to point out the relevance of ensuring a good adherence (taking >90 % of prescribed medication) in early phases of the illness. Adherence to antipsychotic drugs was assessed by the information obtained from patients and close relatives by the staff (nurse, social worker and psychiatrists) involved in the clinical follow-up.
- Functional outcome measured by Disability Assessment Scale (DAS) and Global Assessment Functioning (GAF). [ Time Frame: 3 years ]DAS scores range from 0 (good social functioning) to 5 (bad social functioning). GAF scores range from 1 (many disease symptoms) to 100 (no disease symptoms).
- Relapse rate [ Time Frame: 3 years ]Among patients who achieved clinical improvement and stability (CGI rating ≤ 4 and a decrease of at least 30% on BPRS total score and all BPRS key symptom items, by being rated ≤ 3 for more than 4 consecutive weeks at some point during the first 6 months following program entry), relapse was defined as any of the following criteria that occurred during follow-up: 1 - a rating of either 5 or above on any key BPRS symptom items, 2 - CGI rating of ≥ 6 and a change score of CGI of "much worse" or "very much worse", 3 - hospitalization for psychotic psychopathology, or 4 - completed suicide. The key BPRS symptoms were unusual thought content, hallucinations, suspiciousness, conceptual disorganization and bizarre behaviour. Exacerbation was defined as any 2-point increase of any of the key BPRS symptoms, excluding changes in which the rating remained at the non-psychotic level (i.e., <3).
- Remission rate [ Time Frame: 3 years ]Remission was defined according to Andreasen et al. (2005) criteria covering BPRS and SANS scores: 1.- a score of mild or less (≤3) on six predefined BPRS symptom items: grandiosity, suspiciousness, unusual thought content, hallucinations, conceptual disorganization and mannerisms; and 2.- SANS items scores of ≤2 simultaneously in all items. These criteria are required to be maintained for at least 6 months.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526030
|University Hospital Marqués de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Principal Investigator:||Benedicto Crespo-Facorro, Professor||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.|