Overview

Randomized, Placebo-controlled Multicenter Trial of Lithium Plus Treatment as Usual (TAU) for Acute Suicidal Ideation and Behavior in Patients With Suicidal Major Depressive Episode

Status:
Unknown status

Trial end date:
2018-06-01

Target enrollment:
0

Participant gender:
All

Summary

The primary hypothesis of this confirmatory study is that lithium therapy will acutely decrease suicidal ideation and/or suicidal behaviour in inpatients with a major depressive episode (MDE, unipolar and bipolar disorder according to DSM IV criteria). The specific aim is to test the hypothesis that lithium plus treatment as usual (TAU), compared to placebo plus TAU, results in a significantly greater decrease in suicidal ideation and/or behaviour over 5 weeks in inpatients with MDE.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Technische Universität Dresden

Treatments:

Lithium Carbonate

Criteria

Inclusion Criteria:

- Major depressive episode; inpatient at screening visit; suicidal ideation/behaviour
present defined by a clinical rating of 8 on the Sheehan Suicidality Tracking Scale
(S-STS) and a rating of ≥20 on the Montgomery Asberg Depression Scale (MADRS) at both
screening and baseline visits; both gender, age 18 years.

Exclusion Criteria:

- Contraindication for and history of lithium treatment within the past 6 months;
patient unable to tolerate lithium treatment in the past; comorbid
borderline/antisocial personality disorder, currently active substance dependency;
patients with acute or unstable severe medical conditions, patients unable to
understand the informed consent or involuntary inpatients, positive toxicology screen
(illegal drugs), pregnancy and lactation