Major Depressive Disorder Clinical Trial
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
Verified date | July 2020 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Assessed after 6 weeks of treatment | |
Secondary | The Young Mania Rating Scale (YMRS) | This is a standard outcome tool used to assess mania. | Assessed after 6 weeks of treatment | |
Secondary | 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. | Assessed after 6 weeks of treatment | |
Secondary | 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. | Assessed over 6 weeks of treatment. | |
Secondary | 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. |
Assessed over 6 weeks of treatment | |
Secondary | Treatment -emergent symptom checklist and questionnaire | This checklist and questionnaire will be used to capture a potential range of treatment emergent mixed symptoms. | Assessed over 6 weeks of treatment |
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