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

Study Overview
=================
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).

Official Title
-----------------
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

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Aripiprazole 400mg LAI


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ARIPIPRAZOLE<br>ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month | Drug: Aripiprazole 400mg LAI<br>* Aripiprazole 400mg, IM, Once a month<br>* Other names: ABILIFY;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items |  | 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 | 
| To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI) |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Quality of Life, Functionality, Long Acting Injectable, Aripiprazole, Naturalistic, Open-label, Single Arm, Uncontrolled Study