Schizophrenia Clinical Trial
— ARILAIOfficial 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
Verified date | March 2019 |
Source | Abdi Ibrahim Otsuka |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Abdi Ibrahim Otsuka |
Turkey,
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 |
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