ANZCTR - Registration

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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

Condition category

Condition code

Mental Health

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]

Treatment: Drugs

Comparator / control treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Comparison of patient satisfaction with mirtazapine orally disintegrating formulation to that of mirtazapine conventional tablet formulation.

Timepoint [1]

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]

Identification of factors that patients consider a priority in choosing their antidepressant therapy.

Timepoint [1]

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]

Whether patients' perception of control over their therapeutic decisions influences their likelihood of medication adherance.

Timepoint [2]

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?

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]

Commercial sector/Industry

Name [1]

Adrenalin Strategics

Address [1]

Country [1]

Funding source category [2]

Commercial sector/Industry

Name [2]

Unconditional project grant provided by Organon (Australia) Pty Ltd

Address [2]

Country [2]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Adrenalin Strategics

Address

Country

Secondary sponsor category [1]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central North Adelaide Health Service (Queen Elizabeth Hosptial and Lyell McEwin Hospital), Ethics of Human Research Committee.

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Frank Barbagallo

Address

Adrenalin Strategics
Suite 1
237 Young Street
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 94120555

Fax

+61 3 94120500

fbarbagallo@adrenalinstrategics.com

Contact person for scientific queries

Name

Dr Frank Barbagallo

Address

Adrenalin Strategics
Suite 1
237 Young Street
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 94120555

Fax

+61 3 94120500

fbarbagallo@adrenalinstrategics.com

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.

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