Status:
UNKNOWN
Lithium and Standard Therapy in Resistant Depression
Lead Sponsor:
Universita di Verona
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The principal clinical question is whether lithium is effective in reducing the risk of suicidal behaviour in subjects with treatment-resistant depression and suicide risk. Additionally aims of the st...
Detailed Description
Inclusion criteria: 1. Diagnosis of major depression (clinical diagnosis, guided by DSM-IV criteria). 2. History of attempted suicide or deliberate self-harm in the previous 12 months. 3. Inadequate ...
Eligibility Criteria
Inclusion
- Diagnosis of major depression (clinical diagnosis, guided by DSM-IV criteria).
- History of attempted suicide or deliberate self-harm in the previous 12 months.
- Inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode.
- Uncertainty about which treatment arm would be best for participant.
- Age 18 or above.
- Agreement between investigator and patient to enter the study.
Exclusion
- In addition to major depression, a primary diagnosis of any concurrent Axis I disorder (according to DSM-IV criteria) will constitute an exclusion criterion; by contrast, any concurrent Axis II disorder (according to DSM-IV criteria) will not constitute an exclusion criterion.
- Previous exposure to lithium was associated with lack of efficacy or unwanted adverse reactions.
- Clinical conditions contraindicate the experimental treatment arm (for example thyroid or kidney disease or abnormalities).
- Pregnant/lactating women.
- Women of childbearing potential not practicing a reliable method of contraception.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00927550
Start Date
June 1 2009
End Date
December 1 2012
Last Update
September 17 2009
Active Locations (1)
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1
University of Verona
Verona, Italy, 37134