NCT00400088

A Randomized, Double-blind, Double-dummy, Controlled Trial of Lithium Versus Paroxetine in Subjects With Major Depression Who Have a Family History of Bipolar Disorder or Completed Suicide - a Pilot Study

Terminated Phase 3 Last updated 28 January 2021

What this trial tests

Phase 3 trial testing paroxetine in Major Depressive Disorder in 2 participants. Terminated before completion.

Timeline

1 June 2007

Primary endpoint
1 January 2013

1 January 2013

Quick facts

Lead sponsor	Nova Scotia Health Authority
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	2
Start date	1 June 2007
Primary completion	1 January 2013
Estimated completion	1 January 2013
Sites	1 location across Canada

Drugs / interventions tested

• paroxetine — full drug profile →
• lithium

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Nova Scotia Health Authority — full company profile →

Who can join

18 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Response will be defined as 50% reduction in MADRS score.
  Time frame: weekly
• Remission will be defined as MADRS ≤ 12.
  Time frame: weekly
• The MADRS will be done at week 0,1,2,3,4,5,6.
  Time frame: weekly

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.