Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000297820
Ethics application status
Approved
Date submitted
21/01/2021
Date registered
18/03/2021
Date last updated
12/09/2022
Date data sharing statement initially provided
18/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Quality of Life and Chart Review of Patients Living with Treatment Resistant Major Depressive Disorder at a Single Site in Australia
Scientific title
A Quality of Life and Chart Review of Patients Living with Treatment Resistant Major Depressive Disorder at a Single Site in Australia
Secondary ID [1] 303234 0
PCSNSP002033
Universal Trial Number (UTN)
U1111-1264-0855
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression 320388 0
Condition category
Condition code
Mental Health 318293 318293 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a single-site study of people who are undergoing treatment for Treatment Resistant Depression (TRD). The study aims to understand the quality of life in people with TRD and to understand the clinical characteristics of patients as they present at a single time point (cross-sectional). Patients admitted as an inpatient to Albert Road Clinic will be invited to participate. Following consent participants will complete a quality of life questionnaire (AQoL-8D), participate in a short interview with the research team to complete a depression assessment (HAM-D) and obtain medical and treatment history. This process is expected to take 1.5 hours and will be conducted by a psychiatrist or research coordinator. Participant hospital medical charts will be reviewed to obtain further information regarding medical and treatment history. The results of this study will be used to improve understanding of the burden of disease for people with TRD and to assess the feasibility for creating a registry of data in the future.
Intervention code [1] 319538 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326272 0
Quality of life in people with TRD experiencing depressive episode will be assessed using the AQoL-8D.
Timepoint [1] 326272 0
At the time of once off survey
Secondary outcome [1] 390847 0
Severity of depression and clinical characteristics of TRD patients will be assessed using the HAM-D and a semi-structured interview.
Timepoint [1] 390847 0
At the time of once off survey

Eligibility
Key inclusion criteria
Patients with major depressive disorder experiencing a depressive episode as defined by clinical judgment AND with treatment resistant depression (major depressive disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current depressive episode).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with diminished capacity for decision making in the opinion of the investigator
2. Patients under 18 years of age
3. Patients not fluent in English

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
All continuous variables will be summarised using the following descriptive statistics: n (non-missing sample size), mean, standard deviation, median, maximum and minimum. The frequency and percentages (based on the non-missing sample size) of observed levels will be reported for all categorical measures. 95% confidence intervals will be provided where applicable. The main analysis will comprise all participants in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2021
Actual
1/04/2021
Date of last participant enrolment
Anticipated
31/07/2021
Actual
28/10/2021
Date of last data collection
Anticipated
31/07/2021
Actual
12/04/2022
Sample size
Target
100
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307644 0
Commercial sector/Industry
Name [1] 307644 0
Janssen-Cilag Pty Limited
Country [1] 307644 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag Pty Limited
Address
1-5 Khartoum Road, Macquarie Park, NSW, 2113
Country
Australia
Secondary sponsor category [1] 308333 0
None
Name [1] 308333 0
Address [1] 308333 0
Country [1] 308333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307683 0
Ramsay Health Care NSW/VIC HREC
Ethics committee address [1] 307683 0
Level 8, 154 Pacific Highway, St Leonards, NSW, 2065
Ethics committee country [1] 307683 0
Australia
Date submitted for ethics approval [1] 307683 0
17/11/2020
Approval date [1] 307683 0
21/12/2020
Ethics approval number [1] 307683 0
2020-013

Summary
Brief summary
This is a single-site study of people who are undergoing treatment for Treatment Resistant Depression (TRD). The study aims to understand the quality of life in people with TRD and to understand the clinical characteristics of patients as they present at a single time point (cross-sectional). Patients admitted as an inpatient to Albert Road Clinic will be invited to participate. Following consent participants will complete a quality of life questionnaire (AQoL-8D), participate in a short interview with the research team to complete a depression assessment (HAM-D) and obtain medical and treatment history. Participant hospital medical charts will be reviewed to obtain further information regarding medical and treatment history. The results of this study will be used to improve understanding of the burden of disease for people with TRD and to assess the feasibility for creating a registry of data in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108126 0
Prof Malcolm Hopwood
Address 108126 0
Albert Road Clinic, 31-33 Albert Road, Melbourne, 3004, VIC
Country 108126 0
Australia
Phone 108126 0
+61 3 9279 3569
Fax 108126 0
Email 108126 0
[email protected]
Contact person for public queries
Name 108127 0
Melanie Hurley
Address 108127 0
Albert Road Clinic, 31-33 Albert Road, Melbourne, 3004, VIC
Country 108127 0
Australia
Phone 108127 0
+61 3 9279 3569
Fax 108127 0
Email 108127 0
[email protected]
Contact person for scientific queries
Name 108128 0
Malcolm Hopwood
Address 108128 0
Albert Road Clinic, 31-33 Albert Road, Melbourne, 3004, VIC
Country 108128 0
Australia
Phone 108128 0
+61 3 9279 3569
Fax 108128 0
Email 108128 0
[email protected]

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 an observational study at a single time point and single site which aims to understand the quality of life in people with TRD. This is a preliminary study to assess the feasibility for creating a registry of data in the future. As such the release of individual participant data is not feasible at this time.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.