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

March 5, 2019 updated by: Abdi İbrahim Otsuka

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ARIPIPRAZOLE
ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month
Drug: Aripiprazole 400mg LAI
Aripiprazole 400mg, IM, Once a month
Other Names:
  • ABILIFY

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 24 weeks
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
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
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abdi İbrahim Otsuka

Investigators

  • Principal Investigator: Koksal Alptekin, Prof. Dr, Dokuz Eylul Universitesi Psiyatri Anabilim Dalı

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 031-409-00036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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