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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000970-31-DE

Enrollment

254

Registered

2013-10-01

Start date

2013-11-27

Completion date

Unknown

Last updated

2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis of a major depressive episode

Interventions

Trade Name: Quilonum retard Pharmaceutical Form: Capsule CAS Number: 554-13-2 Other descriptive name: LITHIUM CARBONATE Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: The secondary aim is to observe the influence of the early lithium therapy on other psychometric scales and scores;Primary end point(s): Change in the clinician administered (S-STS) total score between initial and final visit;Timepoint(s) of evaluation of this end point: day 35 after baseline (first intake)	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: The secondary aim is to observe the influence of the early lithium therapy on other psychometric scales and scores;Primary end point(s): Change in the clinician administered (S-STS) total score between initial and final visit;Timepoint(s) of evaluation of this end point: day 35 after baseline (first intake)

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Secondary

Measure	Time frame
Secondary end point(s): Change in the Columbia Suicide Severity Rating Scale (C-SSRS) total score between initial and final visit; MADRS response rate (percent with = 50% decrease from initial to final visit); remission rate (MADRS of 12 or less) at final visit; change in MADRS, Hamilton Anxiety Scale (HAM-A), Clinical Global Impression (CGI) and Barratt Impulsivity Scale (BIS) total score between initial and final visit; weekly change in percent days with 0 score on SSTS compared to initial visit; weekly change in C-SSRS, MADRS, HAM-A score, YMRS compared to initial visit; association between weekly change in MADRS; HAMA-A total score and weekly change in SIS; comparison of the initial SIS, MADRS and HAM-A total scores at the six sites; number and dose of concomitant psychotropic medication; hours of psychotherapy patients receive.;Timepoint(s) of evaluation of this end point: weekly from week 1 to 5	—

Measure

Time frame

Secondary end point(s): Change in the Columbia Suicide Severity Rating Scale (C-SSRS) total score between initial and final visit; MADRS response rate (percent with = 50% decrease from initial to final visit); remission rate (MADRS of 12 or less) at final visit; change in MADRS, Hamilton Anxiety Scale (HAM-A), Clinical Global Impression (CGI) and Barratt Impulsivity Scale (BIS) total score between initial and final visit; weekly change in percent days with 0 score on SSTS compared to initial visit; weekly change in C-SSRS, MADRS, HAM-A score, YMRS compared to initial visit; association between weekly change in MADRS; HAMA-A total score and weekly change in SIS; comparison of the initial SIS, MADRS and HAM-A total scores at the six sites; number and dose of concomitant psychotropic medication; hours of psychotherapy patients receive.;Timepoint(s) of evaluation of this end point: weekly from week 1 to 5

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Countries

Germany

Contacts

Public ContactDepartment of Psychiatry and Psycho

Technische Universität Dresden

00493514582772

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026