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
Overview
- Phase
- Phase 4
- Intervention
- Aripiprazole 400mg LAI
- Conditions
- Schizophrenia
- Sponsor
- Abdi İbrahim Otsuka
- Enrollment
- 23
- Locations
- 15
- Primary Endpoint
- To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale
- Status
- Completed
- Last Updated
- 7 years ago
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).
Investigators
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.
Arms & Interventions
ARIPIPRAZOLE
ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month
Intervention: Aripiprazole 400mg LAI
Outcomes
Primary Outcomes
To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale
Time Frame: 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
Time Frame: 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
Time Frame: 24 weeks
Secondary Outcomes
- To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI)(24 weeks)
- 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)