Skip to main content
OpenTrials
Completed

NCT Number: NCT02697045

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Dahili Tıp Bilimleri Ruh Sağlığı ve Hastalıkları Anabilim Dalı, 01330 Balcalı/, Adana, Turkey (Türkiye)

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Aripiprazole 400mg LAI

Drug

Aripiprazole 400mg, IM, Once a month

Other names: ABILIFY

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Abdi İbrahim Otsuka

Industry

Registry information

Official study 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

Acronym: ARILAI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2016
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.