Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: 3-years Follow-up

NCT03883204 | Unknown Phase 4

• 1 other identifier: ROAC2018_nc3Y
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive deficits are already present at the first break of the illness, seem to remain stable during early phases and noticeably influence daily functioning. Differences among antipsychotics in terms of cognitive effectiveness have turned out to be a topic of increasing research interest. The initially postulated superior neurocognitive effectiveness of second-generation antipsychotics (SGAs) compared to first-generation antipsychotics (FGAs) is currently under debate. Long-term studies would be of great value to evaluate the differential benefits exerted by antipsychotic drugs on cognitive performance. The aim of this study is to investigate the cognitive effects of aripiprazole and risperidone in first-episode psychosis at 3 years.

Conditions

Schizophrenia; Psychotic Disorders; Psychosis

Keywords

Cognition; Antipsychotic Agents; Treatment; Effectiveness; Aripiprazole; Risperidone

Outcome Measures

Primary Outcomes (1)

• Global cognitive index

  In order to calculate a measure of Global Cognitive Functioning (GCF) raw cognitive scores were reversed when appropriate before standardization so they all have the same direction (the higher, the better). According to previous methodology, the GCF was calculated as T-scores, with raw scores of a healthy comparison sample. T scores were converted to deficit scores that reflect presence and severity of cognitive impairment. Deficit scores on all tests were then "averaged" to create the GCF score.

  3 years

Secondary Outcomes (17)

• Change in information processing speed

  3 years

• Change in information processing speed

  3 years

• Change in information processing speed

  3 years

• Change in motor dexterity

  3 years

• Change in working memory

  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: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients followed in the First Episode Psychosis Clinical Program (PAFIP III) from January 2015 to December 2020.
• 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

• 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

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: Professor of Psychiatry

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 20, 2019
• Study Start: January 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 14, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)