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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Aripiprazole 400mg LAI
Sponsored by
Abdi İbrahim Otsuka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Quality of Life, Functionality, Long Acting Injectable, Aripiprazole, Naturalistic, Open-label, Single Arm, Uncontrolled Study

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

  • 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.

Sites / Locations

  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Dahili Tıp Bilimleri Ruh Sağlığı ve Hastalıkları Anabilim Dalı, 01330 Balcalı/
  • Ankara Atatürk Eğitim Araştırma Hastanesi Psikiyatri Kliniği, Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA
  • Ankara Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Cebeci Yerleşkesi, Cebeci Ankara
  • Hacettepe Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Hacettepe Mh. 06230 Ankara
  • Uludağ Üniversitesi Tıp Fakültesi Hastanesi Psikiyatri ABD, Görükle Kampusu, 16059 Görükle/Nilüfer/Bursa
  • Erenköy Ruh ve Sinir Hastalıkları EAH Psikiyatri Polikliniği E servisi (Erkek Servisi) Eğitim Sorumlusu Başhekimlik Binası Uyku Laboratuarı 3. Kat Erenköy - Kadıköy - 34736 İstanbul
  • Erenköy Ruh ve Sinir Hastalıkları EAH Psikiyatri Polikliniği K servisi (Kadın Servisi) 2. Kat, Sinan Ercan Cad. No:29 Kazasker - Erenköy - Kadıköy - 34736 İstanbul
  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Psikiyatri AD, Turgut Özal Caddesi No: 118 PK. 34093 Fatih/ İstanbul
  • Dokuz Eylül Üniversitesi Tıp Fakültesi Dahili Tıp Bilimleri Bölümü Ruh Sağlığı Ve Hastalıkları Anabilim Dalı Mithatpaşa Cad. No 1606 İnciraltı yerleşkesi 35340 Balçova / İzmir
  • Ege Üniversitesi Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Kazımdirik, 35100 Bornova/İzmir
  • Kocaeli Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Eski İstanbul Yolu 10. Km. Umuttepe Yerleşkesi İzmit / Kocaeli
  • Sağlık Bilimleri Üniversitesi Konya Eğitim Araştırma Hastanesi, Meram, Konya
  • Manisa Ruh Sağlığı ve Hastalıkları Hastanesi Şehitler Mh. 814 Sk. No : 28 Merkez - Manisa
  • Mersin Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi Psikiyatri Anabilim Dalı Çiftlikköy Kampüsü 33343 Yenişehir-Mersin
  • 19 Mayıs Üniversitesi Sağlık Uygulama ve Araştırma Merkezi Ruh Sağlığı ve Hastalıkları Anabilim Dalı Atakum / SAMSUN

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ARIPIPRAZOLE

Arm Description

ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month

Outcomes

Primary Outcome Measures

To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale
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
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

Secondary Outcome Measures

To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items
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)

Full Information

First Posted
February 23, 2016
Last Updated
March 5, 2019
Sponsor
Abdi İbrahim Otsuka
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1. Study Identification

Unique Protocol Identification Number
NCT02697045
Brief Title
Effects of Aripiprazole (LAI) on Phychosocial/Cognitive Functioning, pt Reported AcceptabilityofTreatment in Sch
Acronym
ARILAI
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abdi İbrahim Otsuka

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Quality of Life, Functionality, Long Acting Injectable, Aripiprazole, Naturalistic, Open-label, Single Arm, Uncontrolled Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARIPIPRAZOLE
Arm Type
Other
Arm Description
ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month
Intervention Type
Drug
Intervention Name(s)
Aripiprazole 400mg LAI
Other Intervention Name(s)
ABILIFY
Intervention Description
Aripiprazole 400mg, IM, Once a month
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items
Time Frame
24 weeks
Title
To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI),
Time Frame
24 weeks
Title
To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,
Time Frame
24 weeks
Title
To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koksal Alptekin, Prof. Dr
Organizational Affiliation
Dokuz Eylul Universitesi Psiyatri Anabilim Dalı
Official's Role
Principal Investigator
Facility Information:
Facility Name
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Dahili Tıp Bilimleri Ruh Sağlığı ve Hastalıkları Anabilim Dalı, 01330 Balcalı/
City
Adana
Country
Turkey
Facility Name
Ankara Atatürk Eğitim Araştırma Hastanesi Psikiyatri Kliniği, Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA
City
Ankara
Country
Turkey
Facility Name
Ankara Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Cebeci Yerleşkesi, Cebeci Ankara
City
Ankara
Country
Turkey
Facility Name
Hacettepe Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Hacettepe Mh. 06230 Ankara
City
Ankara
Country
Turkey
Facility Name
Uludağ Üniversitesi Tıp Fakültesi Hastanesi Psikiyatri ABD, Görükle Kampusu, 16059 Görükle/Nilüfer/Bursa
City
Bursa
Country
Turkey
Facility Name
Erenköy Ruh ve Sinir Hastalıkları EAH Psikiyatri Polikliniği E servisi (Erkek Servisi) Eğitim Sorumlusu Başhekimlik Binası Uyku Laboratuarı 3. Kat Erenköy - Kadıköy - 34736 İstanbul
City
Istanbul
Country
Turkey
Facility Name
Erenköy Ruh ve Sinir Hastalıkları EAH Psikiyatri Polikliniği K servisi (Kadın Servisi) 2. Kat, Sinan Ercan Cad. No:29 Kazasker - Erenköy - Kadıköy - 34736 İstanbul
City
Istanbul
Country
Turkey
Facility Name
İstanbul Üniversitesi İstanbul Tıp Fakültesi Psikiyatri AD, Turgut Özal Caddesi No: 118 PK. 34093 Fatih/ İstanbul
City
Istanbul
Country
Turkey
Facility Name
Dokuz Eylül Üniversitesi Tıp Fakültesi Dahili Tıp Bilimleri Bölümü Ruh Sağlığı Ve Hastalıkları Anabilim Dalı Mithatpaşa Cad. No 1606 İnciraltı yerleşkesi 35340 Balçova / İzmir
City
Izmir
Country
Turkey
Facility Name
Ege Üniversitesi Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Kazımdirik, 35100 Bornova/İzmir
City
Izmir
Country
Turkey
Facility Name
Kocaeli Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Eski İstanbul Yolu 10. Km. Umuttepe Yerleşkesi İzmit / Kocaeli
City
Kocaeli
Country
Turkey
Facility Name
Sağlık Bilimleri Üniversitesi Konya Eğitim Araştırma Hastanesi, Meram, Konya
City
Konya
Country
Turkey
Facility Name
Manisa Ruh Sağlığı ve Hastalıkları Hastanesi Şehitler Mh. 814 Sk. No : 28 Merkez - Manisa
City
Manisa
Country
Turkey
Facility Name
Mersin Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi Psikiyatri Anabilim Dalı Çiftlikköy Kampüsü 33343 Yenişehir-Mersin
City
Mersin
Country
Turkey
Facility Name
19 Mayıs Üniversitesi Sağlık Uygulama ve Araştırma Merkezi Ruh Sağlığı ve Hastalıkları Anabilim Dalı Atakum / SAMSUN
City
Samsun
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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