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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

Information source: Technische Universitšt Dresden
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Suicidal Ideation/Behavior; Depression

Intervention: Lithium Carbonate (Drug); Placebo (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Technische Universitšt Dresden

Official(s) and/or principal investigator(s):
Michael Bauer, Prof., Principal Investigator, Affiliation: Dept. of Psychiatry and Psychotherapy; TU Dresden
Ute Lewitzka, MD, Study Director, Affiliation: Dept. of Psychiatry and Psychotherapy, TU Dresden

Overall contact:
Michael Bauer, Prof., Phone: +49 351 458, Ext: 2760, Email: michael.bauer@uniklinikum-dresden.de

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: S-STS

Secondary outcome: C-SSRS

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 ‚Č•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

Locations and Contacts

Michael Bauer, Prof., Phone: +49 351 458, Ext: 2760, Email: michael.bauer@uniklinikum-dresden.de

Schlossparc-Clinic, Dept. of Psychiatry and Psychotherapy, Berlin 14059, Germany; Not yet recruiting
Tom Bschor, Prof., Phone: +49 30 3264 1352, Ext: 3, Email: bschor@schlosspark-klinik.de
Tom Bschor, Prof., Principal Investigator

Dept. of Psychiatry and Psychotherapy, Ruhr University Bochum, Bochum 44791, Germany; Not yet recruiting
Georg Juckel, Prof., Phone: +49 234 5077, Ext: 1100, Email: georg.juckel@wkp.lwl.org
Georg Juckel, Prof., Principal Investigator

Dept. of Psychiatry and Psychotherapy, Wuerzburg 97080, Germany; Not yet recruiting
Andreas Reif, Prof., Phone: +49 931 201, Ext: 76403, Email: reif_a@klinik.uni-wuerzburg.de
Andreas Reif, Prof., Principal Investigator

Dept. of Psychiatry and Psychotherapy, Hospital of Dresden Neustadt, Dresden, Saxony 01324, Germany; Not yet recruiting
Burkhard Jabs, Prof, Phone: +49 351 856 69, Ext: 02, Email: burkhard.jabs@khdh.de
Burkhard Jabs, Prof., Principal Investigator

Additional Information

Starting date: January 2014
Last updated: January 16, 2014

Page last updated: August 23, 2015

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