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

Abdi Ibrahim Otsuka

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole 400mg LAI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02697045

031-409-00036

Details and patient eligibility

About

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

Full 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).

Enrollment: 23 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

ARIPIPRAZOLE

Other group

Description:

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

Treatment:

Drug: Aripiprazole 400mg LAI