Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000310460
Ethics application status
Approved
Date submitted
5/06/2007
Date registered
13/06/2007
Date last updated
13/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The Soltab Understanding Patient Preferences in ORal Therapy (SUPPORT) survey
Scientific title
In patients stabilised on mirtazapine therapy for depression, does the new orally disintegrating formulation rate more highly in terms of patient preference?
Universal Trial Number (UTN)
Trial acronym
SUPPORT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 1852 0
Condition category
Condition code
Mental Health 1946 1946 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation open to patients with depression stabilised on conventional tablet formulation of mirtazapine.
Usual maintenance dose of mirtazapine is 30-45mg/day (max 60 mg/day). The dosage is identical for both the conventional and orally disintegrating formulations.
Both the conventional and orally disintegrating formulation is taken once a day, before bed.
Patients complete entry survey regarding attitudes, preferences and satisfaction wtih current antidepressant therapy.

Patients commence one-month trial of treatment using mirtazepine orally disintegrating tablet formulation.

One month later, patients complete exit survey on attitudes, preferences and satisfaction after trial of mirtazepine orally disintegrating tablet formulation.

Randomly selected group of patients approached for follow-up telephone survey at six months after completion of exit survey.
Intervention code [1] 1805 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2765 0
Comparison of patient satisfaction with mirtazapine orally disintegrating formulation to that of mirtazapine conventional tablet formulation.
Timepoint [1] 2765 0
Satisfaction with conventional mirtazapine tablets is measured at baseline and comparison is made to satisfaction with mirtazapine orally disintegrating formulation at 1 month. A randomly selected group of patients is followed up at 6 months.
Secondary outcome [1] 4659 0
Identification of factors that patients consider a priority in choosing their antidepressant therapy.
Timepoint [1] 4659 0
Attitudes regarding priorities in antidepressant choice are examined at baseline. Comparison is made at one month. A randomly selected group of patients will be surveyed at 6 months.
Secondary outcome [2] 4660 0
Whether patients' perception of control over their therapeutic decisions influences their likelihood of medication adherance.
Timepoint [2] 4660 0
Patients perceptions of level of control and self-reports of treatment adherance are measured at baseline. Comparison made at 1 month. Randomly selected group of patients followed up at 6 months.

Eligibility
Key inclusion criteria
Routine presentation of patients treated with conventional oral tablet mirtazapine- opportunistic assessment of patient suitabiltiy for participation in survey- identified patient categories likely to prefer orally disintegrating tablet formulation- after conducting risk-benefit analysis, patients who are likely to have a positive benefit are offered the opportunity to participate- patients must be agreeable to trial of mirtazapine orally disintegrating tablet formulation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not consenting to participation, or unable to provide valid consent- children aged < 18 years- depression not stabilised- duration of mirtazapine therapy < 3 months- known allergy or adverse effects to inactive ingredients in orally disintegrating formulation

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



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2089 0
Commercial sector/Industry
Name [1] 2089 0
Adrenalin Strategics
Country [1] 2089 0
Funding source category [2] 2090 0
Commercial sector/Industry
Name [2] 2090 0
Unconditional project grant provided by Organon (Australia) Pty Ltd
Country [2] 2090 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Adrenalin Strategics
Address
Country
Secondary sponsor category [1] 1894 0
None
Name [1] 1894 0
nil
Address [1] 1894 0
Country [1] 1894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3879 0
Central North Adelaide Health Service (Queen Elizabeth Hosptial and Lyell McEwin Hospital), Ethics of Human Research Committee.
Ethics committee address [1] 3879 0
Ethics committee country [1] 3879 0
Australia
Date submitted for ethics approval [1] 3879 0
Approval date [1] 3879 0
Ethics approval number [1] 3879 0
2007055

Summary
Brief summary
Depressive disorders are associated with more functional disability than most chronic medical illnesses. Despite the availability of several treatment options for depression with similar effectiveness, suboptimal treatment is common, often as a result of poor adherence to medication. The chronic nature of depressive illness, together with the availability of several viable treatment options, increases the importance of patient attitudes and preferences. Improvements such as more comfortable routes of administration have the potential to enhance convenience, tolerability and acceptability for the patient, which may in turn lead to improvements in health-related quality of life. Research suggests that adherence to medication and treatment outcome can be improved if patients perceive greater control over their treatment choice. The SUPPORT Survey gives patients currently treated with regular mirtazapine tablets the opportunity to try the new, fast, orally disintegrating form of mirtazapine known as Avanza SolTab. The SUPPORT Survey aims to provide psychiatrists with valuable feedback from within the Australian community on how satisfied patients really are with regards to their mirtazapine therapy for depression, and gain a better understanding of what patients want from their therapy. Participating psychiatrists will each select up to 10 patients who have been attending their practice for treatment of depression already prescribed conventional mirtazapine tablets. These patients will have already demonstrated a positive clinical response to mirtazapine tablets and be stabilised on therapy. After information has been provided to the patient and informed consent obtained. Patients will be requested to perform a simple survey focussing on their experiences with and preferences for treatment. The survey will either be completed in the clinic waiting room and handed to the receptionist prior to leaving, or completed at home and mailed back to the survey provider via reply-paid post. Treating psychiatrists continue to provide usual care for each patient. One month later, the survey provider (Adrenalin Strategic) will send a similar survey asking about patients' experiences and comparison of the new orally disintegrating formulation of mirtazapine with the conventional tablet. Subsequently, a random sample of patients will be approached to participate in a follow-up phone survey approximately 6 months after the completion of the exit survey.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27908 0
Address 27908 0
Country 27908 0
Phone 27908 0
Fax 27908 0
Email 27908 0
Contact person for public queries
Name 10994 0
Dr Frank Barbagallo
Address 10994 0
Adrenalin Strategics
Suite 1
237 Young Street
Fitzroy VIC 3065
Country 10994 0
Australia
Phone 10994 0
+61 3 94120555
Fax 10994 0
+61 3 94120500
Email 10994 0
[email protected]
Contact person for scientific queries
Name 1922 0
Dr Frank Barbagallo
Address 1922 0
Adrenalin Strategics
Suite 1
237 Young Street
Fitzroy VIC 3065
Country 1922 0
Australia
Phone 1922 0
+61 3 94120555
Fax 1922 0
+61 3 94120500
Email 1922 0
[email protected]

No information has been provided regarding IPD availability


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.