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 Universität 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 Universität 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 ≥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
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