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Lithium Versus Paroxetine in Major Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Lithium
Paroxetine
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, bipolar disorder, manic depressive illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen Elizabeth II Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lithium

Paroxetine

Arm 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).

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.

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS)
The primary outcome measure will be reduction in the score on the Montgomery Asberg Depression Rating Scale (MADRS), which has become the standard outcome tool in clinical trials for assessing symptoms of depression. Response will be defined as 50% reduction in MADRS Remission will be defined as MADRS ≤ 12.

Secondary Outcome Measures

The Young Mania Rating Scale (YMRS)
This is a standard outcome tool used to assess mania.
The Clinical Global Impression (CGI)
The Clinical Global Impression (CGI)is a scale used to measure overall symptom severity, treatment response, and treatment efficacy in patients with mood disorders.
The Columbia Suicide Classification Scale
The Columbia Suicide Classification Scale, used in the FDA analysis of pediatric antidepressants, has become a standard tool used in clinical depression trials and will be used to monitor changes in suicide risk or self-harm weekly.
Barnes Akathisia Rating Scale (BARS)
Barnes Akathisia Rating Scale (BARS): The BARS is a very brief clinical assessment for the presences of akathisia. Akathisia secondary to antidepressants has been associated with increased suicidality. The inclusion of the BARS will serve to delineate akathisia from psychomotor agitation as part of treatment -emergent mixed symptoms.
Treatment -emergent symptom checklist and questionnaire
This checklist and questionnaire will be used to capture a potential range of treatment emergent mixed symptoms.

Full Information

First Posted
August 11, 2011
Last Updated
July 14, 2020
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01416220
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, bipolar disorder, manic depressive illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lithium
Arm Type
Experimental
Arm 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).
Arm Title
Paroxetine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lithium
Other Intervention Name(s)
lithium carbonate
Intervention Description
Study drug will be packaged and supplied in an open-label fashion. There will be a washout period of all active psychotropic medication. Psychotropics will be withdrawn over 5 half-lives with the exception of drugs known to cause withdrawal symptoms (primarily antidepressants), which will be tapered over 10 days. 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.
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Other Intervention Name(s)
paxil
Intervention Description
Study drug will be packaged and supplied in an open-label fashion. There will be a washout period of all active psychotropic medication. Psychotropics will be withdrawn over 5 half-lives with the exception of drugs known to cause withdrawal symptoms (primarily antidepressants), which will be tapered over 10 days. 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.
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale (MADRS)
Description
The primary outcome measure will be reduction in the score on the Montgomery Asberg Depression Rating Scale (MADRS), which has become the standard outcome tool in clinical trials for assessing symptoms of depression. Response will be defined as 50% reduction in MADRS Remission will be defined as MADRS ≤ 12.
Time Frame
Assessed after 6 weeks of treatment
Secondary Outcome Measure Information:
Title
The Young Mania Rating Scale (YMRS)
Description
This is a standard outcome tool used to assess mania.
Time Frame
Assessed after 6 weeks of treatment
Title
The Clinical Global Impression (CGI)
Description
The Clinical Global Impression (CGI)is a scale used to measure overall symptom severity, treatment response, and treatment efficacy in patients with mood disorders.
Time Frame
Assessed after 6 weeks of treatment
Title
The Columbia Suicide Classification Scale
Description
The Columbia Suicide Classification Scale, used in the FDA analysis of pediatric antidepressants, has become a standard tool used in clinical depression trials and will be used to monitor changes in suicide risk or self-harm weekly.
Time Frame
Assessed over 6 weeks of treatment.
Title
Barnes Akathisia Rating Scale (BARS)
Description
Barnes Akathisia Rating Scale (BARS): The BARS is a very brief clinical assessment for the presences of akathisia. Akathisia secondary to antidepressants has been associated with increased suicidality. The inclusion of the BARS will serve to delineate akathisia from psychomotor agitation as part of treatment -emergent mixed symptoms.
Time Frame
Assessed over 6 weeks of treatment
Title
Treatment -emergent symptom checklist and questionnaire
Description
This checklist and questionnaire will be used to capture a potential range of treatment emergent mixed symptoms.
Time Frame
Assessed over 6 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire O'Donovan, MD, FRCPC
Organizational Affiliation
Queen Elizabeth II Health Sciences Centre, CDHA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada

12. IPD Sharing Statement

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Lithium Versus Paroxetine in Major Depression

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