Clinical trial NCT02697045: Effects of Aripiprazole (LAI) on Phychosocial/Cognitive Functioning, pt Reported AcceptabilityofTreatment in Sch
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Quality of Life
Functionality
Long Acting Injectable
Aripiprazole
Naturalistic
Open-label
Single Arm
Uncontrolled Study
Lead sponsor: Abdi İbrahim Otsuka
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
Secondary outcomes:
measure: To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items
timeFrame: 24 weeks
measure: To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI),
timeFrame: 24 weeks
measure: To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,
timeFrame: 24 weeks
measure: To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Dahili Tıp Bilimleri Ruh Sağlığı ve Hastalıkları Anabilim Dalı, 01330 Balcalı/
city: Ankara
country: Turkey
facility: Ankara Atatürk Eğitim Araştırma Hastanesi Psikiyatri Kliniği, Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA
city: Ankara
country: Turkey
facility: Ankara Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Cebeci Yerleşkesi, Cebeci Ankara
city: Ankara
country: Turkey
facility: Hacettepe Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Hacettepe Mh. 06230 Ankara
city: Bursa
country: Turkey
facility: Uludağ Üniversitesi Tıp Fakültesi Hastanesi Psikiyatri ABD, Görükle Kampusu, 16059 Görükle/Nilüfer/Bursa
city: Istanbul
country: Turkey
facility: 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: 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: İstanbul Üniversitesi İstanbul Tıp Fakültesi Psikiyatri AD, Turgut Özal Caddesi No: 118 PK. 34093 Fatih/ İstanbul
city: Izmir
country: Turkey
facility: 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: Ege Üniversitesi Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Kazımdirik, 35100 Bornova/İzmir
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Eski İstanbul Yolu 10. Km. Umuttepe Yerleşkesi İzmit / Kocaeli
city: Konya
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Konya Eğitim Araştırma Hastanesi, Meram, Konya
city: Manisa
country: Turkey
facility: Manisa Ruh Sağlığı ve Hastalıkları Hastanesi Şehitler Mh. 814 Sk. No : 28 Merkez - Manisa
city: Mersin
country: Turkey
facility: Mersin Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi Psikiyatri Anabilim Dalı Çiftlikköy Kampüsü 33343 Yenişehir-Mersin
city: Samsun
country: Turkey
facility: 19 Mayıs Üniversitesi Sağlık Uygulama ve Araştırma Merkezi Ruh Sağlığı ve Hastalıkları Anabilim Dalı Atakum / SAMSUN
Study officials:
affiliation: Dokuz Eylul Universitesi Psiyatri Anabilim Dalı
name: Koksal Alptekin, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: