Effects of Aripiprazole (LAI) on Phychosocial/Cognitive Functioning, pt Reported AcceptabilityofTreatment in Sch
NCT ID: NCT02697045
Last Updated: 2019-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
23 participants
INTERVENTIONAL
2017-01-04
2018-03-31
Brief Summary
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Detailed Description
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* 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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARIPIPRAZOLE
ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month
Aripiprazole 400mg LAI
Aripiprazole 400mg, IM, Once a month
Interventions
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Aripiprazole 400mg LAI
Aripiprazole 400mg, IM, Once a month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
No
Sponsors
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Abdi İbrahim Otsuka
INDUSTRY
Responsible Party
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Principal Investigators
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Koksal Alptekin, Prof. Dr
Role: PRINCIPAL_INVESTIGATOR
Dokuz Eylul Universitesi Psiyatri Anabilim Dalı
Locations
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Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Dahili Tıp Bilimleri Ruh Sağlığı ve Hastalıkları Anabilim Dalı, 01330 Balcalı/
Adana, , Turkey (Türkiye)
Ankara Atatürk Eğitim Araştırma Hastanesi Psikiyatri Kliniği, Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA
Ankara, , Turkey (Türkiye)
Ankara Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Cebeci Yerleşkesi, Cebeci Ankara
Ankara, , Turkey (Türkiye)
Hacettepe Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Hacettepe Mh. 06230 Ankara
Ankara, , Turkey (Türkiye)
Uludağ Üniversitesi Tıp Fakültesi Hastanesi Psikiyatri ABD, Görükle Kampusu, 16059 Görükle/Nilüfer/Bursa
Bursa, , Turkey (Türkiye)
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 (Türkiye)
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 (Türkiye)
İstanbul Üniversitesi İstanbul Tıp Fakültesi Psikiyatri AD, Turgut Özal Caddesi No: 118 PK. 34093 Fatih/ İstanbul
Istanbul, , Turkey (Türkiye)
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 (Türkiye)
Ege Üniversitesi Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Kazımdirik, 35100 Bornova/İzmir
Izmir, , Turkey (Türkiye)
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 (Türkiye)
Sağlık Bilimleri Üniversitesi Konya Eğitim Araştırma Hastanesi, Meram, Konya
Konya, , Turkey (Türkiye)
Manisa Ruh Sağlığı ve Hastalıkları Hastanesi Şehitler Mh. 814 Sk. No : 28 Merkez - Manisa
Manisa, , Turkey (Türkiye)
Mersin Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi Psikiyatri Anabilim Dalı Çiftlikköy Kampüsü 33343 Yenişehir-Mersin
Mersin, , Turkey (Türkiye)
19 Mayıs Üniversitesi Sağlık Uygulama ve Araştırma Merkezi Ruh Sağlığı ve Hastalıkları Anabilim Dalı Atakum / SAMSUN
Samsun, , Turkey (Türkiye)
Countries
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Other Identifiers
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031-409-00036
Identifier Type: -
Identifier Source: org_study_id
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