Clinical trial NCT02039479: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicidal Ideation/Behavior
Depression
Keywords: anti-suicide
Lithium
Depression
suicidal Ideation/behavior
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: S-STS
timeFrame: 5 Weeks
Secondary outcomes:
measure: C-SSRS
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Dept. of Psychiatry and Psychotherapy, Hospital of Dresden Neustadt
state: Saxony
city: Chemnitz
country: Germany
facility: Psychiatrie, Verhaltensmedizin und Psychosomatik
city: Frankfurt am main
country: Germany
facility: Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt
city: Göttingen
country: Germany
facility: Psychatrie Universitätsmedizin Göttingen
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
Study officials:
affiliation: Dept. of Psychiatry and Psychotherapy; TU Dresden
name: Michael Bauer, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Psychiatry and Psychotherapy, TU Dresden
name: Ute Lewitzka, MD
role: STUDY_DIRECTOR
References:
citation: Lewitzka U, Jabs B, Fulle M, Holthoff V, Juckel G, Uhl I, Kittel-Schneider S, Reif A, Reif-Leonhard C, Gruber O, Djawid B, Goodday S, Haussmann R, Pfennig A, Ritter P, Conell J, Severus E, Bauer M. Does lithium reduce acute suicidal ideation and behavior? A protocol for a randomized, placebo-controlled multicenter trial of lithium plus Treatment As Usual (TAU) in patients with suicidal major depressive episode. BMC Psychiatry. 2015 May 19;15:117. doi: 10.1186/s12888-015-0499-5.