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

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole 400mg LAI

• Registration Number: NCT02697045
• Lead Sponsor: Abdi İbrahim Otsuka

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).

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-03
• Study Start: 2017-01-04
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARIPIPRAZOLE	Aripiprazole 400mg LAI	ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (15)

Sağlık Bilimleri Üniversitesi Konya Eğitim Araştırma Hastanesi, Meram, Konya; 🇹🇷 Konya, Turkey

Kocaeli Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Eski İstanbul Yolu 10. Km. Umuttepe Yerleşkesi İzmit / Kocaeli; 🇹🇷 Kocaeli, Turkey

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Dahili Tıp Bilimleri Ruh Sağlığı ve Hastalıkları Anabilim Dalı, 01330 Balcalı/; 🇹🇷 Adana, Turkey

Hacettepe Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Hacettepe Mh. 06230 Ankara; 🇹🇷 Ankara, Turkey

Uludağ Üniversitesi Tıp Fakültesi Hastanesi Psikiyatri ABD, Görükle Kampusu, 16059 Görükle/Nilüfer/Bursa; 🇹🇷 Bursa, 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; 🇹🇷 Izmir, Turkey

Mersin Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi Psikiyatri Anabilim Dalı Çiftlikköy Kampüsü 33343 Yenişehir-Mersin; 🇹🇷 Mersin, Turkey

Ankara Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Cebeci Yerleşkesi, Cebeci Ankara; 🇹🇷 Ankara, 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

Ankara Atatürk Eğitim Araştırma Hastanesi Psikiyatri Kliniği, Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA; 🇹🇷 Ankara, Turkey

İstanbul Üniversitesi İstanbul Tıp Fakültesi Psikiyatri AD, Turgut Özal Caddesi No: 118 PK. 34093 Fatih/ 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

Manisa Ruh Sağlığı ve Hastalıkları Hastanesi Şehitler Mh. 814 Sk. No : 28 Merkez - Manisa; 🇹🇷 Manisa, Turkey

19 Mayıs Üniversitesi Sağlık Uygulama ve Araştırma Merkezi Ruh Sağlığı ve Hastalıkları Anabilim Dalı Atakum / SAMSUN; 🇹🇷 Samsun, Turkey