CompletedPhase 4ACTRN12617000211369

Quality of life (QoL) in patients on Abilify Maintena in the private setting.

Quality of Life (QoL) in schizophrenia patients on Abilify Maintena (Aripiprazole) versus treatment with other atypical anti-psychotics (oral or depot) in a private mental health setting: a pilot randomized controlled trial.


Sponsor

Dr. Benjamin Hadikusumo

Enrollment

100 participants

Start Date

Apr 3, 2017

Study Type

Interventional

Conditions

Summary

To date there has been no documented research on patients cared for in a depot clinic of a private setting (i.e. outside the public mental health sysytem) in Australia. This pilot study aims to evaluate the feasibility of conducting a RCT on the Quality of Life (QoL) amongst schizophrenia patients receiving Abilify Maintena and other anti-psychotics, as managed in a Private Depot Clinic. This study aims to evaluate the benefits of Abilify Maintena in the private specialist setting, independent of the public health service. This will ultimately validate the hypothesis that it can improve Quality of Life of patients, and achieve significant cost savings for the public services, thereby validating increased use of Abilify Maintena in the community.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria1

  • Patients with a formal diagnosis of Schizophrenia as per DSM-V, patients aged between 18 and 65 (inclusive), able to give informed consent.

Exclusion Criteria1

  • Patients who are currently receiving Clozapine, patients with other serious comorbid psychiatric or medical illness, patients who are treatment refractory, patients who are pregnant or breastfeeding, patients who have concomitant use of any other antipsychotic

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Interventions

Comparison between 2 groups. First group will be randomised to receive intramuscular Aripiprazole (long-acting injectable) 400mg every 4 weeks. Subjects who experience adverse effect to this dose

Comparison between 2 groups. First group will be randomised to receive intramuscular Aripiprazole (long-acting injectable) 400mg every 4 weeks. Subjects who experience adverse effect to this dose will receive a lower dose of 300mg 4-weekly. The second (comparator) group will receive any other intramuscular long-acting injectable antipsychotics, including (but not limited to) Risperidone, Olanzapine, Paliperidone, Fluphenazine, Zuclopenthixol Flupenthixol. All subjects enrolled in either group will go through a 3 month stabilisation period, to ensure they are able to tolerate the medications without adverse effects, and they remain stable (no relapse requiring hospitalisation). During this period subjects receive their usual dose of respective long-acting injectable antipsychotic at the appropriate intervals. Randomisation will occur PRIOR to the 3-month stabilisation period. Allocated intervention will become the participants' usual antipsychotic throughout the trial, which is for 6 months post-stabilisation period. Following the completion of trial, patients on both groups will continue on the respective medications they are receiving. Any adjustments to medications made following the trial period will be solely at the discretion of the treating clinician, on clinical grounds. Intervention adherence is assessed through monthly monitoring (i.e. attendance to the depot clinic). Failure of attendance will be followed up by the clinical team (comprising of nurse and psychiatrist) to preserve treatment adherence. Failure to adhere to the regular regimen of the respective medication they are receiving will result in dropout.


Locations(1)

NSW,QLD, Australia

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