AzTrials
AzTrials

SchizophreniaPhase 4ARILAINCT02697045

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

A Phase 4 study testing Aripiprazole 400mg LAI in people with Schizophrenia, run by Abdi İbrahim Otsuka at 15 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole 400mg LAI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
15 sitesTurkey (Türkiye)
Study dates
4 Jan 2017to 31 Mar 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Turkey (Türkiye)15 sites

  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Dahili Tıp Bilimleri Ruh Sağlığı ve Hastalıkları Anabilim Dalı, 01330 Balcalı/

    Adana

  • Ankara Atatürk Eğitim Araştırma Hastanesi Psikiyatri Kliniği, Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA

    Ankara

  • Ankara Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Cebeci Yerleşkesi, Cebeci Ankara

    Ankara

  • Hacettepe Üniversitesi Tıp Fakültesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Hacettepe Mh. 06230 Ankara

    Ankara

  • Uludağ Üniversitesi Tıp Fakültesi Hastanesi Psikiyatri ABD, Görükle Kampusu, 16059 Görükle/Nilüfer/Bursa

    Bursa

  • 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

  • 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

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Psikiyatri AD, Turgut Özal Caddesi No: 118 PK. 34093 Fatih/ İstanbul

    Istanbul

  • 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

  • Ege Üniversitesi Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Kazımdirik, 35100 Bornova/İzmir

    Izmir

  • Kocaeli Üniversitesi Tıp Fakültesi Araştırma ve Uygulama Hastanesi Ruh Sağlığı ve Hastalıkları Anabilim Dalı, Eski İstanbul Yolu 10. Km. Umuttepe Yerleşkesi İzmit / Kocaeli

    Kocaeli

  • Sağlık Bilimleri Üniversitesi Konya Eğitim Araştırma Hastanesi, Meram, Konya

    Konya

  • Manisa Ruh Sağlığı ve Hastalıkları Hastanesi Şehitler Mh. 814 Sk. No : 28 Merkez - Manisa

    Manisa

  • Mersin Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi Psikiyatri Anabilim Dalı Çiftlikköy Kampüsü 33343 Yenişehir-Mersin

    Mersin

  • 19 Mayıs Üniversitesi Sağlık Uygulama ve Araştırma Merkezi Ruh Sağlığı ve Hastalıkları Anabilim Dalı Atakum / SAMSUN

    Samsun

Other trials in Turkey (Türkiye)

About this study

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

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

Read the 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).
Conditions
Schizophrenia
Being tested
Aripiprazole 400mg LAI
Keywords
Schizophrenia, Quality of Life, Functionality, Long Acting Injectable, Aripiprazole, Naturalistic, Open-label, Single Arm, Uncontrolled Study
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aripiprazole 400mg LAIDrug

    Also called ABILIFY

    Aripiprazole 400mg, IM, Once a month

Study groups in NCT02697045
Study groupRoleWhat they receive
ARIPIPRAZOLEOtherABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month
Receives: Drug: Aripiprazole 400mg LAI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients with schizophrenia on psychosocial functioning assesed with psychosocial functioning scale

    Measured: 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

    Measured: 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

    Measured: 24 weeks

Secondary outcomes (4)

  1. To evaluate the cognitive functioning of the patients assesed with PANNS Cognitive Items

    Measured: 24 weeks

  2. To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable (LAI),

    Measured: 24 weeks

  3. To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,

    Measured: 24 weeks

  4. To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2016 (estimated)
  2. Study start4 Jan 2017
  3. Primary completion31 Mar 2018
  4. Study completion31 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02697045
Sponsor's protocol ID
031-409-00036
Acronym
ARILAI
Status last verified
Mar 2019
First submitted
23 Feb 2016
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aripiprazole 400mg LAI in people with Schizophrenia, run by Abdi İbrahim Otsuka at 15 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02697045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in