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

• Status: Completed
• Trial end date: 2018-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abdi İbrahim Otsuka
• Treatments: Aripiprazole

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.