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
Primary Purpose
Suicidal Ideation/Behavior, Depression
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lithium Carbonate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation/Behavior focused on measuring anti-suicide, Lithium, Depression, suicidal Ideation/behavior
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
Sites / Locations
- Dept. of Psychiatry and Psychotherapy, Hospital of Dresden Neustadt
- Psychiatrie, Verhaltensmedizin und PsychosomatikRecruiting
- Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum FrankfurtRecruiting
- Psychatrie Universitätsmedizin GöttingenRecruiting
- Universitätsklinikum HeidelbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
TAU + Placebo
TAU + Lithium
Arm Description
Treatment as Usual + Placebo
Treatment as Usual + Lithium
Outcomes
Primary Outcome Measures
S-STS
Change in the clinician administered (S-STS=Sheehan Suicidality Tracking Scale) total score between initial and final visit
Secondary Outcome Measures
C-SSRS
Change of the total score of C-SSRS (Columbia-Suicide Severity Rating Scale) between start and final visit
Full Information
NCT ID
NCT02039479
First Posted
January 16, 2014
Last Updated
March 14, 2018
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT02039479
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation/Behavior, Depression
Keywords
anti-suicide, Lithium, Depression, suicidal Ideation/behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAU + Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment as Usual + Placebo
Arm Title
TAU + Lithium
Arm Type
Active Comparator
Arm Description
Treatment as Usual + Lithium
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Intervention Description
Lithium as Add on to every necessary treatment as usual
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo as ADD-on to every necessary treatment as usual
Primary Outcome Measure Information:
Title
S-STS
Description
Change in the clinician administered (S-STS=Sheehan Suicidality Tracking Scale) total score between initial and final visit
Time Frame
5 Weeks
Secondary Outcome Measure Information:
Title
C-SSRS
Description
Change of the total score of C-SSRS (Columbia-Suicide Severity Rating Scale) between start and final visit
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Bauer, Prof.
Phone
+49 351 458
Ext
2760
Email
michael.bauer@uniklinikum-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ute Lewitzka, MD
Phone
+49 351 458
Ext
3671
Email
ute.lewitzka@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bauer, Prof.
Organizational Affiliation
Dept. of Psychiatry and Psychotherapy; TU Dresden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ute Lewitzka, MD
Organizational Affiliation
Dept. of Psychiatry and Psychotherapy, TU Dresden
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Psychiatry and Psychotherapy, Hospital of Dresden Neustadt
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01324
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burkhard Jabs, Prof
Phone
+49 351 856 69
Ext
02
Email
burkhard.jabs@khdh.de
First Name & Middle Initial & Last Name & Degree
Burkhard Jabs, Prof.
Facility Name
Psychiatrie, Verhaltensmedizin und Psychosomatik
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Barth, MD
Email
t.barth@skc.de
Facility Name
Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt
City
Frankfurt am main
ZIP/Postal Code
60528
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Reif, Prof.
Phone
069 / 6301-5222
Email
andreas.reif@kgu.de
Facility Name
Psychatrie Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Trost, MD
Email
s.trost@med.uni-goettingen.de
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Gruber, Prof.
Email
oliver.gruber@med.uni.heidelberg.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
25986590
Citation
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.
Results Reference
derived
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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
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