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Trial registered on ANZCTR


Registration number
ACTRN12617000211369
Ethics application status
Approved
Date submitted
17/01/2017
Date registered
8/02/2017
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Date results information initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Quality of life (QoL) in patients on Abilify Maintena in the private setting.

Scientific title
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.
Secondary ID [1] 290939 0
None
Universal Trial Number (UTN)
U1111-1191-7473
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 301662 0
Quality of Life 301663 0
Condition category
Condition code
Mental Health 301370 301370 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296876 0
Treatment: Drugs
Comparator / control treatment
Patients with schizophrenia who are on any other antipsychotics, except Clozapine

The second (comparator) group will receive any other intramuscular long-acting injectable antipsychotics, including (but not limited to) Risperidone, Olanzapine, Paliperidone, Fluphenazine, Zuclopenthixol Flupenthixol. This group will consist of patients who are already on any other long-acting injectable antipsychotic, or on no antipsychotic. If they are not on any antipsychotic, and require one, they will be administered one based on the clinical decision of the treating clinician, as part of the provision of clinical care.
Control group
Active

Outcomes
Primary outcome [1] 300766 0
Change in Quality of Life (QoL) using a validated assessment tool.

The primary QOL outcome is the change in quality of life as assessed by the Quality of Life Scale (QLS).
Timepoint [1] 300766 0
6 months post stabilisation period.
Upon enrolment, patients start a 3-month stabilisation period, prior to the study period of 6 months.
Secondary outcome [1] 330812 0
The change in quality of life as assessed by the World Health Organisation Quality of Life (WHOQOL-BREF)
Timepoint [1] 330812 0
6 months post stabilisation period.
Upon enrolment, patients start a 3-month stabilisation period, prior to the study period of 6 months.
Secondary outcome [2] 331279 0
The change in quality of life as assessed by the Clinical Global Impression Scale – Severity (CGI-S).
Timepoint [2] 331279 0
6 months post stabilisation period.
Upon enrolment, patients start a 3-month stabilisation period, prior to the study period of 6 months.

Eligibility
Key inclusion criteria
Patients with a formal diagnosis of Schizophrenia as per DSM-V, patients aged between 18 and 65 (inclusive), able to give informed consent.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Total study period of 39 weeks (9 months) consisting of a 12-week (3 month) stabilization period, followed by a 26-week (6 months) study active duration. During the stabilization period, ineligible or unstable patients are excluded from the study. The outcome variables will be measured at baseline at start of the study (after the 3-month stabilization period) and at the end of the 6-month study active period.
Summary statistics will be in the form of means and standard deviations for normally distributed continuous variables, medians and interquartile ranges for non-normally distributed variables, and counts and percentages for categorical variables.
Interim analysis is done at the end of 13-weeks.
The null hypothesis is that of no difference in QoL scores between the experimental and control groups. The alternative hypothesis that will be tested is that there is a difference in QoL scores between the two groups. Following checks for statistical assumptions, the difference in mean QoL scores between the treatment groups will be tested through an analysis of covariance (ANCOVA) to detect any statistical significance at the 0.05 level. The difference between QoL scores at the end of the study will be compared, using the baseline QoL measurement as covariate. The results will be used to inform future sample size calculations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 15104 0
2484 - Murwillumbah
Recruitment postcode(s) [2] 15105 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 15107 0
2489 - Pottsville
Recruitment postcode(s) [4] 22112 0
4006 - Fortitude Valley
Recruitment postcode(s) [5] 15108 0
4221 - Palm Beach

Funding & Sponsors
Funding source category [1] 295355 0
Commercial sector/Industry
Name [1] 295355 0
Lundbeck
Address [1] 295355 0
Lundbeck Australia Pty Ltd
1 Innovation Rd
North Ryde
NSW 2113
Australia
Country [1] 295355 0
Australia
Primary sponsor type
Individual
Name
Dr. Benjamin Hadikusumo
Address
The Shrink Company
Suite 21, Wharf Central
75-77 Wharf Street
Tweed Heads
New South Wales 2485
Australia
Country
Australia
Secondary sponsor category [1] 294181 0
None
Name [1] 294181 0
Address [1] 294181 0
Country [1] 294181 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296687 0
Bond University’s Human Research Ethics Committee (BUHREC)
Ethics committee address [1] 296687 0
Research Services
Building 1C, Level 4
Bond University
14 University Drive
Robina
Queensland 4226
Ethics committee country [1] 296687 0
Australia
Date submitted for ethics approval [1] 296687 0
09/02/2017
Approval date [1] 296687 0
02/04/2017
Ethics approval number [1] 296687 0
0000015938

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71790 0
Dr Benjamin Hadikusumo
Address 71790 0
The Shrink Company
Suite 21, Wharf Central
75-77 Wharf Street
Tweed Heads
New South Wales 2485
Country 71790 0
Australia
Phone 71790 0
+61756068700
Fax 71790 0
+61756766670
Email 71790 0
drben@theshrinkcompany.com.au
Contact person for public queries
Name 71791 0
Dr Benjamin Hadikusumo
Address 71791 0
The Shrink Company
Suite 21, Wharf Central
75-77 Wharf Street
Tweed Heads
New South Wales 2485
Country 71791 0
Australia
Phone 71791 0
+61756068700
Fax 71791 0
+61756766670
Email 71791 0
drben@theshrinkcompany.com.au
Contact person for scientific queries
Name 71792 0
Dr Benjamin Hadikusumo
Address 71792 0
The Shrink Company
Suite 21, Wharf Central
75-77 Wharf Street
Tweed Heads
New South Wales 2485
Country 71792 0
Australia
Phone 71792 0
+61756068700
Fax 71792 0
+61756766670
Email 71792 0
drben@theshrinkcompany.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a proof of concept study, a pilot trial.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary