Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: 3-year Follow-up

NCT03090503 | Unknown Phase 4

• 3 other identifiers: ROAC2014_3Y2013-005399-1614-0312
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the efficacy and effectiveness of two of the second-generation antipsychotics (SGAs) most used in our society in the treatment of schizophrenia (Aripiprazole and Risperidone) and the investigators do within an assistance program of early-stage psychosis individuals of the Community of Cantabria, clinical reference for the treatment of this disease in the Spanish Autonomous Community. Patients are included in a prospective naturalistic study, open flexible-doses and randomized into one of two possible patterns of treatment that includes the protocol.

Conditions

Schizophrenia; Psychotic Disorders; Psychosis

Keywords

Antipsychotic agents; Treatment; Effectiveness; Aripiprazole; Risperidone

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Aripiprazole and Risperidone at long term as measured by Percentage of discontinuation

  Percentage of discontinuation of the initially assigned treatment: patients who completed the 3 year follow-up assessment and changed initial antipsychotic. Four reasons for the discontinuation are recorded: 1.- insufficient efficacy; 2.- marked side-effects; 3.- patient reported non-adherence and 4.- other causes. If more than one reason for discontinuation is present, the most important reason according to the above ranking is selected. Antipsychotic treatment data (doses, discontinuation and concomitant medications) are registered every 6 months. Insufficient efficacy is established at the treating physician's judgment only after at least three weeks of treatment.

  3 years

Secondary Outcomes (9)

• Change in general psychopathology measured by BPRS at long term

  3 years

• Change in overall clinical status measured by CGI at long term

  3 years

• Change in negative symptoms measured by SANS at long term

  3 years

• Change in positive symptoms measured by SAPS at long term

  3 years

• Emergence of adverse events by using the Scale of the Udvalg for Kliniske Undersogelser (UKU)

  3 years

Study Arms (2)

Aripiprazole

ACTIVE COMPARATOR

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

Drug: Aripiprazole

Risperidone

ACTIVE COMPARATOR

Oral, dose range 1-6 mg/day, once or twice a day during study duration.

Drug: Risperidone

Interventions

Aripiprazole DRUG

Initial dose: 10 mg.

Also known as: Abilify

Aripiprazole

Risperidone DRUG

Initial dose: 2 mg.

Also known as: Risperdal

Risperidone

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Experiencing their first episode of psychosis (First Episode of Psychosis is defined as that psychopathological state in which for the first time and regardless of its duration, the patient has enough severe psychotic symptoms to allow a diagnosis of psychosis, having received no specific psychiatric treatment for him).
• Living in the catchment area (Cantabria).
• 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 with loss of consciousness.

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Aripiprazole; Risperidone

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; Pyrimidinones; Pyrimidines

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: March 14, 2017
• First Posted: March 24, 2017
• Study Start: June 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2021
• Last Updated: July 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)