None listed
Conditions
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.
Interventions
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 o
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.
Sponsors
Adrenalin Strategics
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed