Comparative Study of Aripiprazole, Quetiapine and Ziprasidone in the Treatment of First Episode Nonaffective Psychosis

NCT02305823 | Completed Phase 4

• 2 other identifiers: AZQ2005CI 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. The 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.

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)

  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.

  6 weeks

Secondary Outcomes (5)

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

  6 weeks, 3 months and 1 year

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

  6 weeks, 3 months and 1 year

• Change in the severity of depressive symptoms measured by the Calgary Depression Scale (CDS)

  6 weeks, 3 months and 1 year

• Change in maniac symptoms measured by the Young Mania Rating Scale (YMRS)

  6 weeks, 3 months and 1 year

• Adherence to treatment

  1 year

Other Outcomes (1)

• Relapse rate

  1 year

Study Arms (3)

Aripiprazole

ACTIVE COMPARATOR

Oral, dose range 5-30 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: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years.
• Living in the catchment area.
• Experiencing their first episode of psychosis.
• No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks.
• Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder.

You may not qualify if:

• Meeting 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 Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Related Publications (6)

• Son J MV, Gomez-Revuelta M, Ayesa-Arriola R, Vazquez-Bourgon J, Foz VO, Ruiz-Veguilla M, Garrido N, Tordesillas-Gutierrez D, Setien-Suero E, Crespo-Facorro B. Comparison of aripiprazole and risperidone effectiveness in first episode non-affective psychosis: Rationale and design of a prospective, randomized, 3-phase, investigator-initiated study (PAFIP-3). Rev Psiquiatr Salud Ment (Engl Ed). 2021 Jul-Sep;14(3):157-163. doi: 10.1016/j.rpsmen.2021.08.002.

  PMID: 34456030 DERIVED

• Delgado-Alvarado M, Tordesillas-Gutierrez D, Ayesa-Arriola R, Canal M, de la Foz VO, Labad J, Crespo-Facorro B. Plasma prolactin levels are associated with the severity of illness in drug-naive first-episode psychosis female patients. Arch Womens Ment Health. 2019 Jun;22(3):367-373. doi: 10.1007/s00737-018-0899-x. Epub 2018 Aug 10.

  PMID: 30097769 DERIVED

• Tordesillas-Gutierrez D, Ayesa-Arriola R, Delgado-Alvarado M, Robinson JL, Lopez-Morinigo J, Pujol J, Dominguez-Ballesteros ME, David AS, Crespo-Facorro B. The right occipital lobe and poor insight in first-episode psychosis. PLoS One. 2018 Jun 1;13(6):e0197715. doi: 10.1371/journal.pone.0197715. eCollection 2018.

  PMID: 29856773 DERIVED

• Pelayo-Teran JM, Gajardo-Galan V, Gomez-Revuelta M, Ortiz-Garcia de la Foz V, Ayesa-Arriola R, Tabares-Seisdedos R, Crespo-Facorro B. Duration of active psychosis and functional outcomes in first-episode non-affective psychosis. Eur Psychiatry. 2018 Aug;52:29-37. doi: 10.1016/j.eurpsy.2018.03.003. Epub 2018 Mar 31.

  PMID: 29614389 DERIVED

• Vazquez-Bourgon J, Perez-Iglesias R, Ortiz-Garcia de la Foz V, Suarez Pinilla P, Diaz Martinez A, Crespo-Facorro B. Long-term metabolic effects of aripiprazole, ziprasidone and quetiapine: a pragmatic clinical trial in drug-naive patients with a first-episode of non-affective psychosis. Psychopharmacology (Berl). 2018 Jan;235(1):245-255. doi: 10.1007/s00213-017-4763-x. Epub 2017 Oct 26.

  PMID: 29075885 DERIVED

• Ayesa-Arriola R, Alcaraz EG, Hernandez BV, Perez-Iglesias R, Lopez Morinigo JD, Duta R, David AS, Tabares-Seisdedos R, Crespo-Facorro B. Suicidal behaviour in first-episode non-affective psychosis: Specific risk periods and stage-related factors. Eur Neuropsychopharmacol. 2015 Dec;25(12):2278-88. doi: 10.1016/j.euroneuro.2015.09.008. Epub 2015 Sep 28.

  PMID: 26475577 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, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, 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: November 20, 2014
• First Posted: December 3, 2014
• Study Start: October 1, 2005
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2014
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)