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

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ClinicalTrials.gov Identifier: NCT02697045
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole 400mg LAI Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 4, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
ARIPIPRAZOLE
ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month
Drug: Aripiprazole 400mg LAI
Aripiprazole 400mg, IM, Once a month
Other Name: ABILIFY




Primary Outcome Measures :
  1. To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale [ Time Frame: 24 weeks ]
  2. 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 [ Time Frame: 24 weeks ]
  3. 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 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items [ Time Frame: 24 weeks ]
  2. To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI), [ Time Frame: 24 weeks ]
  3. To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment, [ Time Frame: 24 weeks ]
  4. To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI) [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697045


Locations
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Turkey
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Dahili Tıp Bilimleri Ruh Sağlığı ve Hastalıkları Anabilim Dalı, 01330 Balcalı/
Adana, Turkey
Ankara Atatürk Eğitim Araştırma Hastanesi Psikiyatri Kliniği, Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA
Ankara, Turkey
Ankara Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Cebeci Yerleşkesi, Cebeci Ankara
Ankara, 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
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
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
İstanbul Üniversitesi İstanbul Tıp Fakültesi Psikiyatri AD, Turgut Özal Caddesi No: 118 PK. 34093 Fatih/ İstanbul
Istanbul, 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
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
Sağlık Bilimleri Üniversitesi Konya Eğitim Araştırma Hastanesi, Meram, Konya
Konya, Turkey
Manisa Ruh Sağlığı ve Hastalıkları Hastanesi Şehitler Mh. 814 Sk. No : 28 Merkez - Manisa
Manisa, Turkey
Mersin Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi Psikiyatri Anabilim Dalı Çiftlikköy Kampüsü 33343 Yenişehir-Mersin
Mersin, Turkey
19 Mayıs Üniversitesi Sağlık Uygulama ve Araştırma Merkezi Ruh Sağlığı ve Hastalıkları Anabilim Dalı Atakum / SAMSUN
Samsun, Turkey
Sponsors and Collaborators
Abdi İbrahim Otsuka
Investigators
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Principal Investigator: Koksal Alptekin, Prof. Dr Dokuz Eylul Universitesi Psiyatri Anabilim Dalı

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Responsible Party: Abdi İbrahim Otsuka
ClinicalTrials.gov Identifier: NCT02697045     History of Changes
Other Study ID Numbers: 031-409-00036
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Abdi İbrahim Otsuka:
Schizophrenia
Quality of Life
Functionality
Long Acting Injectable
Aripiprazole
Naturalistic
Open-label
Single Arm
Uncontrolled Study
Additional relevant MeSH terms:
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Aripiprazole
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists