NCT02039479

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

4.2 years

First QC Date

January 16, 2014

Last Update Submit

March 14, 2018

Conditions

Suicidal Ideation/BehaviorDepression

Keywords

anti-suicideLithiumDepressionsuicidal Ideation/behavior

Outcome Measures

Primary Outcomes (1)

  • S-STS

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

    5 Weeks

Secondary Outcomes (1)

  • C-SSRS

    5 weeks

Study Arms (2)

TAU + Placebo

PLACEBO COMPARATOR

Treatment as Usual + Placebo

Drug: Placebo

TAU + Lithium

ACTIVE COMPARATOR

Treatment as Usual + Lithium

Drug: Lithium Carbonate

Interventions

Lithium CarbonateDRUG

Lithium as Add on to every necessary treatment as usual

TAU + Lithium
PlaceboDRUG

Placebo as ADD-on to every necessary treatment as usual

TAU + Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dept. of Psychiatry and Psychotherapy, Hospital of Dresden Neustadt

Dresden, Saxony, 01324, Germany

NOT YET RECRUITING

Psychiatrie, Verhaltensmedizin und Psychosomatik

Chemnitz, 09116, Germany

RECRUITING

Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt

Frankfurt am Main, 60528, Germany

RECRUITING

Psychatrie Universitätsmedizin Göttingen

Göttingen, 37075, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69115, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25986590DERIVED

MeSH Terms

Conditions

Suicidal IdeationBehaviorDepression

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium Compounds

Study Officials

  • Michael Bauer, Prof.

    Dept. of Psychiatry and Psychotherapy; TU Dresden

    PRINCIPAL INVESTIGATOR

  • Ute Lewitzka, MD

    Dept. of Psychiatry and Psychotherapy, TU Dresden

    STUDY DIRECTOR

Central Study Contacts

Michael Bauer, Prof.

CONTACT

+49 351 458michael.bauer@uniklinikum-dresden.de

Ute Lewitzka, MD

CONTACT

+49 351 458ute.lewitzka@uniklinikum-dresden.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 17, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

DE(5)