Randomized evaluation of the effectiveness of lithium in subjects with treatment-resistant depression and suicide risk. An independent, pragmatic, multicentre, parallel-group, superiority trial. - LAST-RD

• Conditions: Treatment-resistant depression and suicide risk.; MedDRA version: 9.1Level: LLTClassification code 10012397Term: Depression suicidal

• Registration Number: EUCTR2009-011409-17-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(a) Diagnosis of major depression (clinical diagnosis, guided by DSM-IV criteria).
(b) History of attempted suicide or deliberate self-harm in the previous 12 months.
(c) Inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode.
(d) Uncertainty about which treatment arm would be best for the participant.
(e) Age 18 or above.
(f) Agreement between investigator and patient to enter the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(a) 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.
(b) Previous exposure to lithium was associated with lack of efficacy or unwanted adverse reactions.
(c) Clinical conditions contraindicate the experimental treatment arm (for example thyroid or kidney disease or abnormalities).
(d) Pregnant/lactating women.
(e) Women of childbearing potential not practicing a reliable method of contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified