Clinical trial NCT01416220: Lithium Versus Paroxetine in Major Depression
Official title: A Randomized, Open-label, Trial of Lithium Versus Paroxetine in Subjects With Major Depression Who Have a Family History of Bipolar Disorder or Completed Suicide
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: depression
bipolar disorder
manic depressive illness
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to look at how well people respond to two different drug treatments for depression. Clinically, people can respond differently to different treatments for reasons which are not always clear. Some research shows that people with a family history of bipolar disorder or completed suicide may react differently to standard medications used to treat depression than those without a family history. The investigators need to know if these drugs are effective to use in patients with depression who have a family history of bipolar disorder or completed suicide.

Detailed description: Lithium is a mood stabilizing drug that has been used to treat people with both bipolar disorder and depression for the last 50 years. It is available to the public by prescription in Canada and has been used by millions of people world wide. Paroxetine is an antidepressant drug that has been used to treat people with depression for the past 10 years. It is also available to the public by prescription in Canada and has been used by millions world wide.

Subjects who join the study, will be given one of the study drugs, either lithium or paroxetine.

Subjects will be randomized "like the flip of a coin" to receive either lithium or paroxetine.

The study drug will be taken once a day by mouth and the daily dose adjusted to find the right dose for the subject. The study drug will be taken for a 6-week period and subjects will be assessed by the research team on a weekly basis.

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

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Assessed after 6 weeks of treatment
Secondary outcomes:
measure: The Young Mania Rating Scale (YMRS)
timeFrame: Assessed after 6 weeks of treatment
measure: The Clinical Global Impression (CGI)
timeFrame: Assessed after 6 weeks of treatment
measure: The Columbia Suicide Classification Scale
timeFrame: Assessed over 6 weeks of treatment.
measure: Barnes Akathisia Rating Scale (BARS)
timeFrame: Assessed over 6 weeks of treatment
measure: Treatment -emergent symptom checklist and questionnaire
timeFrame: Assessed over 6 weeks of treatment
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Queen Elizabeth II Health Sciences Centre, CDHA
name: Claire O'Donovan, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: