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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

NCT02039479 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2018-03-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lithium Carbonate

Lithium as Add on to every necessary treatment as usual

DRUG

Placebo

Placebo as ADD-on to every necessary treatment as usual

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Michael Bauer, Prof. · Dept. of Psychiatry and Psychotherapy; TU Dresden

  • Ute Lewitzka, MD · Dept. of Psychiatry and Psychotherapy, TU Dresden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-03-31
Completion
2018-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039479 on ClinicalTrials.gov