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

Not Applicable

• Conditions: Suicidal Ideation/Behavior; Depression
• Interventions: Drug: Placebo; Drug: Lithium Carbonate

• Registration Number: NCT02039479
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Detailed Description

The study will consist of 254 adult patients, hospitalized for a major depressive episode with suicidal ideation and/or behaviour who will be randomized to two groups of each 127 participants. All study participants will receive treatment as usual in the hospital, including (psycho)pharmacological treatment and, if needed, psychotherapy plus a 5-week course of lithium or placebo. Rating scales will be used daily resp. weekly to measure suicidal ideation and/or behaviour, depression, anxiety, mixed/manic features and impulsiveness. Experienced clinicians will rate suicidal ideation and/or behaviour as well as depression twice a week and anxiety, mixed/manic features and impulsiveness once a week.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-17
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-15
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU + Placebo	Placebo	Treatment as Usual + Placebo
TAU + Lithium	Lithium Carbonate	Treatment as Usual + Lithium

Primary Outcome Measures

Name	Time	Method
S-STS	5 Weeks	Change in the clinician administered (S-STS=Sheehan Suicidality Tracking Scale) total score between initial and final visit

Secondary Outcome Measures

Name	Time	Method
C-SSRS	5 weeks	Change of the total score of C-SSRS (Columbia-Suicide Severity Rating Scale) between start and final visit

Trial Locations

Locations (5)

Psychiatrie, Verhaltensmedizin und Psychosomatik; 🇩🇪 Chemnitz, Germany

Psychatrie Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Dept. of Psychiatry and Psychotherapy, Hospital of Dresden Neustadt; 🇩🇪 Dresden, Saxony, Germany

Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt am main, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany