NCT02697045

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

February 23, 2016

Last Update Submit

March 5, 2019

Conditions

Schizophrenia

Keywords

SchizophreniaQuality of LifeFunctionalityLong Acting InjectableAripiprazoleNaturalisticOpen-labelSingle ArmUncontrolled Study

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

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

    24 weeks

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

    24 weeks

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

    24 weeks

  • To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI)

    24 weeks

Study Arms (1)

ARIPIPRAZOLE

OTHER

ABILIFY MAINTENA 400 MG LAI Aripiprazole 400mg, IM, Once a month

Drug: Aripiprazole 400mg LAI

Interventions

Aripiprazole 400mg LAIDRUG

Aripiprazole 400mg, IM, Once a month

Also known as: ABILIFY
ARIPIPRAZOLE

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

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

Adana, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

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

Bursa, Turkey (Türkiye)

Location

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)

Location

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)

Location

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

Istanbul, Turkey (Türkiye)

Location

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)

Location

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

Izmir, Turkey (Türkiye)

Location

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)

Location

Sağlık Bilimleri Üniversitesi Konya Eğitim Araştırma Hastanesi, Meram, Konya

Konya, Turkey (Türkiye)

Location

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

Manisa, Turkey (Türkiye)

Location

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

Mersin, Turkey (Türkiye)

Location

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

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Koksal Alptekin, Prof. Dr

    Dokuz Eylul Universitesi Psiyatri Anabilim Dalı

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 3, 2016

Study Start

January 4, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

Locations

TU(15)