Lithium Versus Paroxetine in Major Depression

NCT01416220 | Withdrawn Phase 4 DMC

• 1 other identifier: MoodDig-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depression; bipolar disorder; manic depressive illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Young Mania Rating Scale (YMRS)

  Assessed after 6 weeks of treatment

• The Clinical Global Impression (CGI)

  Assessed after 6 weeks of treatment

• The Columbia Suicide Classification Scale

  Assessed over 6 weeks of treatment.

• Barnes Akathisia Rating Scale (BARS)

  Assessed over 6 weeks of treatment

• Treatment -emergent symptom checklist and questionnaire

  Assessed over 6 weeks of treatment

Study Arms (2)

Lithium

EXPERIMENTAL

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

Paroxetine

ACTIVE COMPARATOR

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

Interventions

Lithium DRUG

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.

Also known as: lithium carbonate

Lithium

Paroxetine DRUG

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.

Also known as: paxil

Paroxetine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2E2, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Bipolar Disorder

Interventions

Lithium; Lithium Carbonate; Paroxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Claire O'Donovan, MD, FRCPC

  Queen Elizabeth II Health Sciences Centre, CDHA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 12, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CA (1)