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Lithium Versus Paroxetine in Major Depression

Information source: Nova Scotia Health Authority
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Lithium (Drug); Paroxetine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Nova Scotia Health Authority

Official(s) and/or principal investigator(s):
Claire O'Donovan, MD, FRCPC, Principal Investigator, Affiliation: Queen Elizabeth II Health Sciences Centre, CDHA

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Montgomery Asberg Depression Rating Scale (MADRS)

Secondary outcome:

The Young Mania Rating Scale (YMRS)

The Clinical Global Impression (CGI)

The Columbia Suicide Classification Scale

Barnes Akathisia Rating Scale (BARS)

Treatment -emergent symptom checklist and questionnaire

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia B3H 2E2, Canada
Additional Information

Starting date: September 2011
Last updated: February 12, 2015

Page last updated: August 23, 2015

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