Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide
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Purpose
This study is being done to look at how well people respond to two very different drug treatments for depression. Clinically, people with depression can respond differently to drug treatments for reasons which are not always clear. Some of our own recent research suggests that people with depression who have a family history of bipolar disorder or completed suicide, may react differently to standard antidepressant medications than those without such a family history. Our data shows that family history of completed suicide, as well as the known predictor of family history of bipolar disorder, may help identify a pre-bipolar high risk group i.e. they currently have depression but at some future date will declare a bipolar illness (manic-depression) by virtue of development of a manic episode also. Our research suggests that treatment- emergent symptoms in response to a trial of antidepressant, such as agitation may be strong predictors of future bipolarity and inherently dangerous particularly as they are not ascribed to the antidepressant treatment. Finally, it is possible that this subgroup of those with depressive illness may respond better and more safely to lithium, a mood stabiliser used in known bipolar depression.
The objective of this proposal is to investigate response to acute lithium treatment in subjects who meet the diagnostic criteria for major depression, but who are potentially at risk for bipolar disorder, by virtue of family history of bipolarity or completed suicide.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: paroxetine Drug: lithium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Double-dummy, Controlled Trial of Lithium Versus Paroxetine in Subjects With Major Depression Who Have a Family History of Bipolar Disorder or Completed Suicide - a Pilot Study |
- Response will be defined as 50% reduction in MADRS score. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- Remission will be defined as MADRS ≤ 12. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- The MADRS will be done at week 0,1,2,3,4,5,6. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- The Hamilton Depression Rating Scale (HAM -D)-17 item scale, at weeks 0 and 6. [ Time Frame: weeks 0 and 6 ] [ Designated as safety issue: Yes ]
- Hamilton Anxiety Rating Scale (HAM-A),at weeks 0 and 6. [ Time Frame: weeks 0 and 6 ] [ Designated as safety issue: No ]
- The Young Mania Rating Scale (YMRS), at weeks 0,1,2,3,4,5,6. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- The Bipolar Depression Rating Scale (BDRS) (42),at weeks 0,1,2,3,4,5,6. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- Checklist of DSM IV symptoms of mania/ hypomania, with additional questions assessing the presence of mood lability, abnormally high energy, abnormally high libido, and rage. Done at weeks 0,1,2,3,4,5,6. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- The Beck Suicide Scale (BSS), at weeks 0, 1, 2,3,4,5, 6. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
| Enrollment: | 2 |
| Study Start Date: | June 2007 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: lithium group
Start at 600 mg po hs. Dose titrated up to a serum level of between 0.6 and 1.1 mmol/l.
|
Drug: lithium
start at 600mg po hs with dose to be flexibly titrated to a serum level of between 0.6 and 1.1 mmol/l.
Other Names:
|
|
Active Comparator: paroxetine group
Start dose at 20 mg po od. If no clinical improvement(<20% reduction in MADRS score) by week 4 dose to be increased to 40 mg po od.
|
Drug: paroxetine
Start at 20 mg po od. Increase dose to 40 mg po od at week 4 if there is less than 20 % reduction in MADRS scores.
Other Name: paxil
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Not currently participating in a drug or medical device clinical trial
- Male or female over the age of 18
- DSM - IV Diagnosis of major depression
- Positive family history of bipolar disorder or completed suicide
Exclusion Criteria:
- Not able to give informed consent
- Pregnant or breast-feeding
- Current additional psychiatric diagnoses including Panic Disorder, Post -Traumatic Stress Disorder (PTSD) or Psychosis
- History of mania or hypomania
- Active substance abuse or dependence in the last 6 months
- Current depressive episode less than 4 weeks or greater than 12 months in duration
- Current or prior adequate trial of lithium or paroxetine
- Current use of other medications such as antidepressants for the treatment of depression
- Clinically significant medical illness, in particular kidney problems
Contacts and Locations| Canada, Nova Scotia | |
| Capital District Health Authority - Dept. of Psychiatry | |
| Halifax, Nova Scotia, Canada, B3H 2E2 | |
| Principal Investigator: | Claire O'Donovan M O'Donovan, MB FRCPC | Capital District Health Authority and Dalhousie University |
More Information
Publications:
| Responsible Party: | Julie Garnham, Dr. Claire O'Donovan, Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT00400088 History of Changes |
| Other Study ID Numbers: | CDHA012, CDHA-RS/2006-076 |
| Study First Received: | November 15, 2006 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Capital District Health Authority, Canada:
|
Major Depressive Disorder Depression Bipolar Disorder Manic Depressive Illness |
Randomized Trial Antidepressant Treatment Lithium Treatment |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Suicide Depressive Disorder, Major Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Self-Injurious Behavior 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 June 17, 2013