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

NCT02526030 | Completed Phase 4

• 2 other identifiers: AZQ2005_3YCI 2005-0308007
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

psychosis; antipsychotic agents; treatment; effectiveness

Outcome Measures

Primary Outcomes (1)

• Effectiveness of antipsychotics (percentage of discontinuation of the initially assigned treatment)

  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.

  3 years

Secondary Outcomes (4)

• Change in general psychopathology measured by the Brief Psychiatric Rating Scale (BPRS)

  3 years

• Change in positive and negative symptoms measured by the Scale for the Assessment of Negative and Positive Symptoms (SANS and SAPS)

  3 years

• Adherence to treatment measured by Morinsky questionnaire

  3 years

• Functional outcome measured by Disability Assessment Scale (DAS) and Global Assessment Functioning (GAF).

  3 years

Other Outcomes (2)

• Relapse rate

  3 years

• Remission rate

  3 years

Study Arms (3)

Aripiprazole

ACTIVE COMPARATOR

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

Drug: Aripiprazole

Quetiapine

ACTIVE COMPARATOR

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

Drug: Quetiapine

Ziprasidone

ACTIVE COMPARATOR

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

Drug: Ziprasidone

Interventions

Aripiprazole DRUG

Also known as: Abilify

Aripiprazole

Quetiapine DRUG

Also known as: Seroquel

Quetiapine

Ziprasidone DRUG

Also known as: Zeldox

Ziprasidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients followed in the First Episode Psychosis Clinical Program (PAFIP II) from October 2005 to January 2011.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Marques de Valdecilla: lead
• Centro de Investigación Biomédica en Red de Salud Mental: collaborator
• Instituto de Investigación Marqués de Valdecilla: collaborator

Study Sites (1)

University Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Related Publications (2)

• 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.

  PMID: 31974576 DERIVED

• 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.

  PMID: 30215723 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Aripiprazole; Quetiapine Fumarate; ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 18, 2015
• Study Start: October 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)