Lithium Versus Paroxetine in Major Depression

Nova Scotia Health Authority (NSHA)

Status and phase: Withdrawn; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Lithium; Drug: Paroxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT01416220

MoodDig-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Lithium

Experimental group

Description:

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).

Treatment:

Drug: Lithium

Paroxetine

Active Comparator group

Description:

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.

Treatment:

Drug: Paroxetine