Effectivenes of second generation antipsychotics in first episode psychosis patients.

Randomized, flexible-dose, open-label comparison to investigate the effectivenes of second generation antipsychotics in first episode psychosis patients. - second generation antipsychotics in first episode psychosis patients

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005399-16-ES

Enrollment

200

Registered

2014-06-09

Start date

2014-08-05

Completion date

Unknown

Last updated

2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FIRST EPISODE DRUG-NAÏVE OF PSYCHOSIS (SCHIZOPHRENIA SPECTRUM DISORDERS) MedDRA version: 17.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: ABILIFY Product Name: aripiprazole Product Code: aripiprazole Pharmaceutical Form: Capsule, hard INN or Proposed INN: ARIPIPRAZOLE CAS Number: 129722-12-9 Current Sponsor code: EU/1/04/276

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: From May 2014 to May 2016 all referrals to PAFIP were screened for patients who met the following criteria: 1) 15-60 years; 2) living in the catchment area; 3) experiencing their first episode of psychosis; 4) no prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks; 5) DSM-IV criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder. The diagnoses were confirmed using the Structured Clinical Interview for DSM-IV (SCID ?I) (First et al., 2001) carried out by an experienced psychiatrist 6 months on from the baseline visit. Our operational definition for a ?first episode of psychosis? included individuals with a non-affective psychosis (meeting the inclusion criteria defined above) who have not received previously antipsychotic treatment regardless the duration of psychosis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients were excluded for any of the following reasons: 1) meeting DSM-IV criteria for drug dependence, 2) meeting DSM-IV criteria for mental retardation, 3) having a history of neurological disease or head injury.

Design outcomes

Primary

Measure	Time frame
Main Objective: TO HEAD-TO-HEAD COMPARE THE CLINICAL EFFECTIVENESS OF ARIPIPRAZOLE AND RISPERIDONE IN TREATING PATIENTS WITH A FIRST EPISODE OF NON-AFFECTIVE PSYCHOSIS.;Secondary Objective: TO EVALUATE DIFFERENCES IN SIDE EFFECTS PROFILE BETWEEN TREATMENTS TO EVALUATE DIFFERENCES IN COGNITIVE EFFICACY BETWEEN TREATMENTS TO ASSESS DIFFERENCES IN FUNCTIONAL RECOVERY BETWEEN TREATMENTS;Primary end point(s): THE PRIMARY END POINT WILL BE A 30% OF REDUCTION OF TOTAL SCORE OF BRIEF PSYCHIATRIC RATING SCALE (COMPARED TO BASELINE).;Timepoint(s) of evaluation of this end point: AT 3 WEEKS	—

Measure

Time frame

Main Objective: TO HEAD-TO-HEAD COMPARE THE CLINICAL EFFECTIVENESS OF ARIPIPRAZOLE AND RISPERIDONE IN TREATING PATIENTS WITH A FIRST EPISODE OF NON-AFFECTIVE PSYCHOSIS.;Secondary Objective: TO EVALUATE DIFFERENCES IN SIDE EFFECTS PROFILE BETWEEN TREATMENTS TO EVALUATE DIFFERENCES IN COGNITIVE EFFICACY BETWEEN TREATMENTS TO ASSESS DIFFERENCES IN FUNCTIONAL RECOVERY BETWEEN TREATMENTS;Primary end point(s): THE PRIMARY END POINT WILL BE A 30% OF REDUCTION OF TOTAL SCORE OF BRIEF PSYCHIATRIC RATING SCALE (COMPARED TO BASELINE).;Timepoint(s) of evaluation of this end point: AT 3 WEEKS

—

Secondary

Measure	Time frame
Secondary end point(s): THE PRIMARY END POINT WILL BE A 30% OF REDUCTION OF TOTAL SCORE OF BRIEF PSYCHIATRIC RATING SCALE (COMPARED TO BASELINE).;Timepoint(s) of evaluation of this end point: AT 6 WEEKS	—

Countries

Spain

Contacts

Public ContactBenedicto Crespo-Facorro

Hospital Universitario Marqués de Valdecilla / IDIVAL

crespob@unican.es+34942202545

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 13, 2026