Lithium and Standard Therapy in Resistant Depression

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 study are: (a) to assess whether lithium is effective in improving depressive symptomatology in subjects with treatment-resistant depression and suicide risk; (b) to assess the tolerability profile of lithium.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universita di Verona
• Treatments: Lithium Carbonate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.