Randomized, placebo-controlled multicenter trial of lithium plus treatment asusual (TAU) for acute suicidal ideation and behaviour in patients with suicidalmajor depressive episode

Phase 1

• Conditions: Diagnosis of a major depressive episode; inpatient at screening visit; suicidalideation/behaviour present defined by a clinical rating of = 8 on the SheehanSuicidality Tracking Scale (S-STS) at screening and a rating of =20 on the MontgomeryAsberg Depression Scale (MADRS) at both screening and baseline visits; bothgender, age =18 years.; MedDRA version: 20.0Level: PTClassification code 10012397Term: Depression suicidalSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-000970-31-DE
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-01
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

Diagnosis of a 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) at screening visit and a rating of =20 on the Montgomery
Asberg Depression Scale (MADRS) at both screening and baseline visits; both
gender, age = 18 years.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

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, drug dependence (according to ICD10 or DSMIV and positive Diagnose in MINI), pregnancy and lactation

Study & Design

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