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SchizophreniaPhase 4PAFIP2_3YNCT02526030

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

A Phase 4 study testing Aripiprazole, Quetiapine and Ziprasidone in people with Schizophrenia and Psychotic Disorders, run by Fundación Marques de Valdecilla at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia, Psychotic Disorders
What is being tested?
Aripiprazole, Quetiapine and Ziprasidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteSpain
Study dates
Oct 2008to Jun 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University Hospital Marqués de Valdecilla

    Santander, Cantabria, 39008

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Aripiprazole, Quetiapine, Ziprasidone
Keywords
psychosis, antipsychotic agents, treatment, effectiveness
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AripiprazoleDrug

    Also called Abilify

  • QuetiapineDrug

    Also called Seroquel

  • ZiprasidoneDrug

    Also called Zeldox

Study groups in NCT02526030
Study groupRoleWhat they receive
AripiprazoleActive comparatorOral, dose range 10-30 mg/day, once or twice a day, during study duration
Receives: Drug: Aripiprazole
QuetiapineActive comparatorOral, dose range 100-600 mg/day, once or twice a day, during study duration
Receives: Drug: Quetiapine
ZiprasidoneActive comparatorOral, dose range 40-160 mg/day, once or twice a day, during study duration
Receives: Drug: Ziprasidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (4)

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

    Measured by BPRS.

    Measured: 3 years

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

    Measured by SANS and SAPS.

    Measured: 3 years

  3. Adherence to treatment measured by Morinsky questionnaire

    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.

    Measured: 3 years

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

    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).

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startOct 2008
  3. Primary completionFeb 2014
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02526030
Sponsor's protocol ID
AZQ2005_3Y
Other IDs
CI 2005-0308007
Acronym
PAFIP2_3Y
Status last verified
Mar 2017
First submitted
12 Aug 2015
Last updated
14 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31974576

  • 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.

    PubMed 30215723

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aripiprazole, Quetiapine and Ziprasidone in people with Schizophrenia and Psychotic Disorders, run by Fundación Marques de Valdecilla at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of antipsychotics (percentage of discontinuation of the initially assigned treatment) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02526030, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.

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