Lithium Versus Paroxetine in Major Depression

This study is not yet open for participant recruitment.
Verified August 2011 by Capital District Health Authority, Canada
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01416220
First received: August 11, 2011
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Lithium
Drug: Paroxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Assessed after 6 weeks of treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Assessed after 6 weeks of treatment ] [ Designated as safety issue: No ]
    This is a standard outcome tool used to assess mania.

  • The Clinical Global Impression (CGI) [ Time Frame: Assessed after 6 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed over 6 weeks of treatment. ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Assessed over 6 weeks of treatment ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Assessed over 6 weeks of treatment ] [ Designated as safety issue: Yes ]
    This checklist and questionnaire will be used to capture a potential range of treatment emergent mixed symptoms.


Estimated Enrollment: 76
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lithium
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).
Drug: Lithium

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.

Other Name: lithium carbonate
Active Comparator: Paroxetine
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.
Drug: Paroxetine

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.

Other Name: paxil

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416220

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Julie Garnham, BN    902-473-7144    jgarnham@dal.ca   
Principal Investigator: Claire O'Donovan, MD, FRCPC         
Sub-Investigator: Martin Alda, MD, FRCPC         
Sub-Investigator: Tomas Hajek, MD, PhD         
Sub-Investigator: Cindy Calkin, MD, FRCPC         
Sub-Investigator: Julie Garnham, BN         
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Claire O'Donovan, MD, FRCPC Queen Elizabeth II Health Sciences Centre, CDHA
  More Information

No publications provided

Responsible Party: Dr. Claire O'Donovan, Department of Psychiatry Queen Elizabeth II Health Sciences Centre, Capital District Health Authority
ClinicalTrials.gov Identifier: NCT01416220     History of Changes
Other Study ID Numbers: MoodDig-001
Study First Received: August 11, 2011
Last Updated: August 12, 2011
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
depression
bipolar disorder
manic depressive illness

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lithium
Lithium Carbonate
Paroxetine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on April 17, 2014