Lithium Versus Paroxetine in Major Depression
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, bipolar disorder, manic depressive illness
Eligibility Criteria
Inclusion Criteria:
- men or women
- age of 18 years or older
- meet criteria for major depressive episode, and have a family history of bipolar disorder or completed suicide
Exclusion Criteria:
- subjects not able to give informed consent
- pregnant or breast-feeding women
- current panic disorder, post traumatic stress disorder or psychosis
- subjects with a history of mania or hypomania
- subjects with active substance abuse or dependence in the last 6 months
- current depressive episode less than 4 weeks or greater than 12 months in duration
- adequate trial of lithium or paroxetine (lithium level ≥ 0.6mmols/l; paroxetine 20mgs ≥ 5 weeks) for this episode of depression
- concurrent use of other antidepressants or augmenting agents for the treatment of depression
- clinically significant medical illness, in particular renal impairment
Sites / Locations
- Queen Elizabeth II Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Lithium
Paroxetine
Following the enrollment period, subjects will enter a six-week randomized treatment period with either lithium or paroxetine. Lithium carbonate will be commenced at 600mgs hs, with increase to 900mgs at day 7. Dose will be flexibly titrated to give a serum level between 0.5 and 1.1mmol/l. At visit 4, the dose of lithium may be adjusted (within the range of 0.6 and 1.1 mmol/l).
Following the enrollment period, subjects will enter a six-week randomized treatment period with either lithium or Paroxetine.Paroxetine will be commenced at 10mgs and increased to 20mgs on day 7.At visit 4, the dose of paroxetine may be increased to 40mgs, if there is no response (less than 20% reduction in MADRS score) as per current Canadian guidelines.