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

NCT ID: NCT02039479

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-06-30

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.

Conditions

Suicidal Ideation/Behavior; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TAU + Placebo

Treatment as Usual + Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo as ADD-on to every necessary treatment as usual

TAU + Lithium

Treatment as Usual + Lithium

Group Type: ACTIVE_COMPARATOR

Lithium Carbonate

Intervention Type: DRUG

Lithium as Add on to every necessary treatment as usual

Interventions

Lithium Carbonate

Lithium as Add on to every necessary treatment as usual

Intervention Type: DRUG

Placebo

Placebo as ADD-on to every necessary treatment as usual

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bauer, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Psychiatry and Psychotherapy; TU Dresden

Ute Lewitzka, MD

Role: STUDY_DIRECTOR

Dept. of Psychiatry and Psychotherapy, TU Dresden

Locations

Dept. of Psychiatry and Psychotherapy, Hospital of Dresden Neustadt

Dresden, Saxony, Germany

Site Status: NOT_YET_RECRUITING

Psychiatrie, Verhaltensmedizin und Psychosomatik

Chemnitz, , Germany

Site Status: RECRUITING

Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt

Frankfurt am Main, , Germany

Site Status: RECRUITING

Psychatrie Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status: RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Bauer, Prof.

Role: CONTACT

michael.bauer@uniklinikum-dresden.de

+49 351 458 ext. 2760

Ute Lewitzka, MD

Role: CONTACT

ute.lewitzka@uniklinikum-dresden.de

+49 351 458 ext. 3671

Facility Contacts

Burkhard Jabs, Prof

Role: primary

burkhard.jabs@khdh.de

+49 351 856 69 ext. 02

Thomas Barth, MD

Role: primary

t.barth@skc.de

Andreas Reif, Prof.

Role: primary

andreas.reif@kgu.de

069 / 6301-5222

Sarah Trost, MD

Role: primary

s.trost@med.uni-goettingen.de

Oliver Gruber, Prof.

Role: primary

oliver.gruber@med.uni.heidelberg.de

References

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.

Reference Type: DERIVED

PMID: 25986590 (View on PubMed)

Other Identifiers

01KG1307

Identifier Type: -

Identifier Source: org_study_id