None listed
Conditions
Brief summary
Most (85-90%) depression is treated in primary care. Many patients in primary care are now receiving long term maintenance therapy with antidepressants to prevent recurrence. Whilst research indicates long term maintenance treatment benefits some patients referred to and treated in secondary care, there is no similar evidence for patients with milder symptoms treated exclusively in primary care. Recurrence of depressive episodes is lower in primary than secondary care treated patients (35% vs 75%). This study is a triple blinded randomised controlled trial of continued treatment vs tapered withdrawal of fluoxetine in patients who have been treated in primary care for at least twelve months and who are not currently experiencing depression. Patients will be followed for 18 months to monitor recurrence of depression, side effects, and general social and occupational functioning and the two arms compared. This study will further our understanding of the optimal long term treatment of depression in primary care by assessing whether there is any benefit in using antidpressants for preventing recurrence of depression, or whether the medication can safely be stopped.
Interventions
Placebo masked tapered cessation of current selective serotonin reuptake inhibitor antidepressant medication. Participants in the intervention group will have their medication tapered over a month to placebo which will continue for 18 months. The dose of active drug in each capsule will be halved each week for the first four weeks then discontinued. The placebo is a non lactose inert powder filled oral capsule. After the taper period both the active drug and the placebo/taper arm will continue t
Placebo masked tapered cessation of current selective serotonin reuptake inhibitor antidepressant medication. Participants in the intervention group will have their medication tapered over a month to placebo which will continue for 18 months. The dose of active drug in each capsule will be halved each week for the first four weeks then discontinued. The placebo is a non lactose inert powder filled oral capsule. After the taper period both the active drug and the placebo/taper arm will continue to take one tablet daily for the 18 month study period.
Sponsors
Health Research Council of NZ
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Aged between 18 and 75 years Living in the Christchurch, Wellington or Auckland urban areas Historical diagnosis of unipolar depressive disorder for which current therapy is maintenance antidepressants Diagnosed and treated for depression in primary care On treatment with antidepressants for at least 12 months Currently in remission: Montgomery Asberg Depression Rating Scale (MADRS) Patient willing to try discontinuation
Exclusion criteria
Diagnosis / treatment carried out in secondary care setting (inpatient or outpatient referral to psychiatrist) for the index episode Unipolar depression not primary reason for prescription of SSRI Bipolar disorder Psychotic disorder Substance dependence disorder Postnatal depression in the last 12 months Pregnancy Serious current suicide risk (score >2 on MADRS suicide item) English language skills inadequate to understand and respond to rating scales Concurrent use of any other antidepressant
Outcome results
None listed