Anxiety, Depression
Conditions
Brief summary
Th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal depression.
Interventions
DRUGSertraline
BEHAVIORALCognitive Behavioural Therapy
Sponsors
Pfizer
University of Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women with an infant \> 2 months and \< 8 months of age * Infant born after a full-term pregnancy * Infant born with no congenital abnormalities * Diagnosis of depression with postnatal onset according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV).
Exclusion criteria
* positive serum pregnancy test; * concurrent psychiatric disorder (excepting co-morbid anxiety); * recent history of antidepressant usage (within the last month); * history of major allergy or drug allergy; * history of substance abuse; * prior non-response to sertraline, or prior non-response to adequate trials of two selective serotonin reuptake inhibitors (SSRIs); * predisposition to headache, migraine or nausea; * tobacco habit in excess of 10 cigarettes per day; * caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per day; * ongoing dental work; * extreme levels of depression (psychotic); * suicidal intent; * participation in any medical trial within the previous three months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Beck Anxiety Inventory | 24 weeks |
| Parenting Stress Index | 24 weeks |
Countries
Australia
Outcome results
None listed