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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02039479
• Other study ID #: 01KG1307
• Status: Recruiting
• Phase: N/A
• First received: January 16, 2014
• Last updated: March 14, 2018
• Start date: January 2014
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: Technische Universität Dresden
• Contact: Michael Bauer, Prof.
• Phone: +49 351 458
• Email: michael.bauer[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Suicidal Ideation
• Suicidal Ideation/Behavior

Intervention

Drug:
• Lithium Carbonate
Lithium as Add on to every necessary treatment as usual
• Placebo
Placebo as ADD-on to every necessary treatment as usual

Locations

Country	Name	City	State
Germany	Psychiatrie, Verhaltensmedizin und Psychosomatik	Chemnitz
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	Psychatrie Universitätsmedizin Göttingen	Göttingen
Germany	Universitätsklinikum Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-STS	Change in the clinician administered (S-STS=Sheehan Suicidality Tracking Scale) total score between initial and final visit	5 Weeks
Secondary	C-SSRS	Change of the total score of C-SSRS (Columbia-Suicide Severity Rating Scale) between start and final visit	5 weeks