Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in the Treatment of First Episode Nonaffective Psychosis (PAFIP2)
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|ClinicalTrials.gov Identifier: NCT02305823|
Recruitment Status : Completed
First Posted : December 3, 2014
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: this is a prospective, randomized, flexible-dose, open-label study. At study intake, all patients but eight were antipsychotic naïve. Dose ranges were 5-20 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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV Study of the 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)|
|Actual Study Start Date :||October 2005|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||May 2014|
Active Comparator: Aripiprazole
Oral, dose range 5-30 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: 6 weeks ]The main outcomes of effectiveness were the percentage of discontinuation of the initially assigned treatment (patients who completed the 6 weeks follow-up assessment and changed initial antipsychotic) and the 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. Data on antipsychotic treatment (doses, discontinuation and concomitant medications) were registered weekly during the first 4 weeks and at 6 week. 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: 6 weeks, 3 months and 1 year ]Measured by BPRS. The patients were defined as responders to the optimum dose of antipsychotic at 6 weeks if a >40% reduction of the BPRS scores at intake and had a CGI severity score of ≤ 4. In addition, we also explored to rate of responders if a cutoff of ≥ 50% reduction of the BPRS total scores at intake was used.
- Change in positive and negative symptoms measured by the Scale for the Assessment of Negative and Positive Symptoms (SANS and SAPS) [ Time Frame: 6 weeks, 3 months and 1 year ]Measured by SANS and SAPS.
- Change in the severity of depressive symptoms measured by the Calgary Depression Scale (CDS) [ Time Frame: 6 weeks, 3 months and 1 year ]Measured by CDS.
- Change in maniac symptoms measured by the Young Mania Rating Scale (YMRS) [ Time Frame: 6 weeks, 3 months and 1 year ]Measured by YMRS.
- Adherence to treatment [ Time Frame: 1 year ]
- Relapse rate [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305823
|University Hospital Marques 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, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain|