Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in Treatment of First Episode Psychosis: 3-year Follow-up

NCT ID: NCT02526030

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2015-06-30

Brief 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.

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.

Conditions

Schizophrenia; Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole

Oral, dose range 10-30 mg/day, once or twice a day, during study duration

Group Type: ACTIVE_COMPARATOR

Aripiprazole

Intervention Type: DRUG

Quetiapine

Oral, dose range 100-600 mg/day, once or twice a day, during study duration

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

Ziprasidone

Oral, dose range 40-160 mg/day, once or twice a day, during study duration

Group Type: ACTIVE_COMPARATOR

Ziprasidone

Intervention Type: DRUG

Interventions

Aripiprazole

Intervention Type: DRUG

Quetiapine

Intervention Type: DRUG

Ziprasidone

Intervention Type: DRUG

Other Intervention Names

Abilify; Seroquel; Zeldox

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Investigación Biomédica en Red de Salud Mental

NETWORK

Sponsor Role: collaborator

Instituto de Investigación Marqués de Valdecilla

OTHER

Sponsor Role: collaborator

Fundación Marques de Valdecilla

OTHER

Sponsor Role: lead

Responsible Party

Benedicto Crespo-Facorro

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benedicto Crespo-Facorro, Professor

Role: PRINCIPAL_INVESTIGATOR

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.

Locations

University Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Countries

Spain

References

Gomez-Revuelta M, Pelayo-Teran JM, Juncal-Ruiz M, Vazquez-Bourgon J, Suarez-Pinilla P, Romero-Jimenez R, Setien Suero E, Ayesa-Arriola R, Crespo-Facorro B. Antipsychotic Treatment Effectiveness in First Episode of Psychosis: PAFIP 3-Year Follow-Up Randomized Clinical Trials Comparing Haloperidol, Olanzapine, Risperidone, Aripiprazole, Quetiapine, and Ziprasidone. Int J Neuropsychopharmacol. 2020 Apr 23;23(4):217-229. doi: 10.1093/ijnp/pyaa004.

Reference Type: DERIVED

PMID: 31974576 (View on PubMed)

Gomez-Revuelta M, Pelayo-Teran JM, Juncal-Ruiz M, Ortiz-Garcia de la Foz V, Vazquez-Bourgon J, Gonzalez-Pinto A, Crespo-Facorro B. Long-Term Antipsychotic Effectiveness in First Episode of Psychosis: A 3-Year Follow-Up Randomized Clinical Trial Comparing Aripiprazole, Quetiapine, and Ziprasidone. Int J Neuropsychopharmacol. 2018 Dec 1;21(12):1090-1101. doi: 10.1093/ijnp/pyy082.

Reference Type: DERIVED

PMID: 30215723 (View on PubMed)

Other Identifiers

CI 2005-0308007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AZQ2005_3Y

Identifier Type: -

Identifier Source: org_study_id