Overview

Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide

Status:
Terminated
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study is being done to look at how well people respond to two very different drug treatments for depression. Clinically, people with depression can respond differently to drug treatments for reasons which are not always clear. Some of our own recent research suggests that people with depression who have a family history of bipolar disorder or completed suicide, may react differently to standard antidepressant medications than those without such a family history. Our data shows that family history of completed suicide, as well as the known predictor of family history of bipolar disorder, may help identify a pre-bipolar high risk group i.e. they currently have depression but at some future date will declare a bipolar illness (manic-depression) by virtue of development of a manic episode also. Our research suggests that treatment- emergent symptoms in response to a trial of antidepressant, such as agitation may be strong predictors of future bipolarity and inherently dangerous particularly as they are not ascribed to the antidepressant treatment. Finally, it is possible that this subgroup of those with depressive illness may respond better and more safely to lithium, a mood stabiliser used in known bipolar depression. The objective of this proposal is to investigate response to acute lithium treatment in subjects who meet the diagnostic criteria for major depression, but who are potentially at risk for bipolar disorder, by virtue of family history of bipolarity or completed suicide.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nova Scotia Health Authority
Treatments:
Lithium Carbonate
Paroxetine
Criteria
Inclusion Criteria:

- Not currently participating in a drug or medical device clinical trial

- Male or female over the age of 18

- DSM - IV Diagnosis of major depression

- Positive family history of bipolar disorder or completed suicide

Exclusion Criteria:

- Not able to give informed consent

- Pregnant or breast-feeding

- Current additional psychiatric diagnoses including Panic Disorder, Post -Traumatic
Stress Disorder (PTSD) or Psychosis

- History of mania or hypomania

- Active substance abuse or dependence in the last 6 months

- Current depressive episode less than 4 weeks or greater than 12 months in duration

- Current or prior adequate trial of lithium or paroxetine

- Current use of other medications such as antidepressants for the treatment of
depression

- Clinically significant medical illness, in particular kidney problems