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

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697045
• Other study ID #: 031-409-00036
• Status: Completed
• Phase: Phase 4
• Start date: January 4, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2019
• Source: Abdi Ibrahim Otsuka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole 400mg LAI
Aripiprazole 400mg, IM, Once a month

Locations

Country	Name	City	State
Turkey	Çukurova Üniversitesi Tip Fakültesi Balcali Hastanesi Dahili Tip Bilimleri Ruh Sagligi ve Hastaliklari Anabilim Dali, 01330 Balcali/	Adana
Turkey	Ankara Atatürk Egitim Arastirma Hastanesi Psikiyatri Klinigi, Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA	Ankara
Turkey	Ankara Üniversitesi Tip Fakültesi Ruh Sagligi ve Hastaliklari Anabilim Dali, Cebeci Yerleskesi, Cebeci Ankara	Ankara
Turkey	Hacettepe Üniversitesi Tip Fakültesi Ruh Sagligi ve Hastaliklari Anabilim Dali, Hacettepe Mh. 06230 Ankara	Ankara
Turkey	Uludag Üniversitesi Tip Fakültesi Hastanesi Psikiyatri ABD, Görükle Kampusu, 16059 Görükle/Nilüfer/Bursa	Bursa
Turkey	Erenköy Ruh ve Sinir Hastaliklari EAH Psikiyatri Poliklinigi E servisi (Erkek Servisi) Egitim Sorumlusu Bashekimlik Binasi Uyku Laboratuari 3. Kat Erenköy - Kadiköy - 34736 Istanbul	Istanbul
Turkey	Erenköy Ruh ve Sinir Hastaliklari EAH Psikiyatri Poliklinigi K servisi (Kadin Servisi) 2. Kat, Sinan Ercan Cad. No:29 Kazasker - Erenköy - Kadiköy - 34736 Istanbul	Istanbul
Turkey	Istanbul Üniversitesi Istanbul Tip Fakültesi Psikiyatri AD, Turgut Özal Caddesi No: 118 PK. 34093 Fatih/ Istanbul	Istanbul
Turkey	Dokuz Eylül Üniversitesi Tip Fakültesi Dahili Tip Bilimleri Bölümü Ruh Sagligi Ve Hastaliklari Anabilim Dali Mithatpasa Cad. No 1606 Inciralti yerleskesi 35340 Balçova / Izmir	Izmir
Turkey	Ege Üniversitesi Hastanesi Ruh Sagligi ve Hastaliklari Anabilim Dali, Kazimdirik, 35100 Bornova/Izmir	Izmir
Turkey	Kocaeli Üniversitesi Tip Fakültesi Arastirma ve Uygulama Hastanesi Ruh Sagligi ve Hastaliklari Anabilim Dali, Eski Istanbul Yolu 10. Km. Umuttepe Yerleskesi Izmit / Kocaeli	Kocaeli
Turkey	Saglik Bilimleri Üniversitesi Konya Egitim Arastirma Hastanesi, Meram, Konya	Konya
Turkey	Manisa Ruh Sagligi ve Hastaliklari Hastanesi Sehitler Mh. 814 Sk. No : 28 Merkez - Manisa	Manisa
Turkey	Mersin Üniversitesi Saglik Arastirma ve Uygulama Merkezi Hastanesi Psikiyatri Anabilim Dali Çiftlikköy Kampüsü 33343 Yenisehir-Mersin	Mersin
Turkey	19 Mayis Üniversitesi Saglik Uygulama ve Arastirma Merkezi Ruh Sagligi ve Hastaliklari Anabilim Dali Atakum / SAMSUN	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Abdi Ibrahim Otsuka

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items		24 weeks
Secondary	To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI),		24 weeks
Secondary	To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,		24 weeks
Secondary	To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI)		24 weeks