Effects of Aripiprazole (LAI) on Phychosocial/Cognitive Functioning, pt Reported AcceptabilityofTreatment in Sch

Nautralsitic, Open-label, Single Arm Study Evaluating Effects of Aripiprazole LAI on Phychosocial&Congitive Functioning, Patient Reported Acceptability of Treatment Regarding QoL, Subjective Well-being Under Neuroleptic Medication in Sch

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02697045

Acronym

ARILAI

Enrollment

Registered

2016-03-03

Start date

2017-01-04

Completion date

2018-03-31

Last updated

2019-03-06

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

Conditions

Schizophrenia

Keywords

Schizophrenia, Quality of Life, Functionality, Long Acting Injectable, Aripiprazole, Naturalistic, Open-label, Single Arm, Uncontrolled Study

Brief summary

Nautralsitic, Open-label, Single Arm, Uncontrolled Study Evaluating the Effects of Long Acting Injectable (LAI) on Phychosocial Functioning Congitive Functioning and Patient Reported Acceptability of Treatment 'Reported Acceptability of Treatment' Regarding Quality of Life Subjective Well-being Under Neuroleptic Medication in Schizophrenia Patients

Detailed description

Primary Objective * To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning, quality of life and patient reported acceptability of treatment. Secondary Objective(s) * To evaluate the cognitive functioning of the patients * To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI), * To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment, * To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI).

Interventions

DRUGAripiprazole 400mg LAI

Aripiprazole 400mg, IM, Once a month

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Inclusion Criteria: * Participants 18-45 of years age fulfilling DSM-IV-TR diagnostic criteria of schizophrenia, * Disease history of ≤ 3 years (≤ 3 years after the emergence of first psychotic symptoms), * A history of symptom exacerbation or relapse when not receiving antipsychotics therefore requiring maintenance antipsychotic treatment, * Informed written consent, * Not on any antipsychotic treatment at least for 3 months or requiring a switch in treatment for any reason (lack of efficacy/ inadequate response to current antipsychotic(s), intolerance, nonadherence), and with the potential to benefit from extended treatment with an LAI formulation, in the investigator's opinion. * Lack of efficacy is defined as subjects with a baseline total PANSS score ≥70 or ≥2 items scoring ≥4 in the Positive or Negative Symptom Subscale * Lack of tolerability is defined as the presence of clinically relevant side effects with the previous antipsychotic medication. * Being literate in order to be able to answer the self report scales. *

Exclusion criteria

* DSM-IV-TR diagnosis other than schizophrenia or experiencing acute depressive symptoms in the past 30 days requiring ADT depending on the clinical decision of the investigator. * Antipsychotic resistant or refractory schizophrenia * A history of failure to clozapine treatment or response to clozapine treatment only. * Significant risk of violent behavior or risk of self-harm * Currently meets DSM-IV-TR criteria for alcohol and substance dependence * Any clinically significant medical or neurological disorder * Any medically significant abnormal laboratory test or ECG result at screening * Pregnant, lactating.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale	24 weeks
To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia quality of life assesed with Heinrich's quality of life scale	24 weeks
To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia patient reported acceptability of treatment assesed with Subjective Well Being Under Neuroleptic Treatment Scale	24 weeks

Secondary

Measure	Time frame
To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items	24 weeks
To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI)	24 weeks
To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI),	24 weeks
To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,	24 weeks

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026