An interventional study of Lithium Carbonate and Placebo in Suicidal Ideation/Behavior and Depression, sponsored by Technische Universität Dresden. Status unknown at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-15.
Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment
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.
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.
530 studies on the registry are indexed under Suicidal Ideation; 198 are open to participants now.
This study's planned enrollment of 254 is above the median of 80 across 440 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Treatment as Usual + Placebo
Drug: Placebo
Treatment as Usual + Lithium
Drug: Lithium Carbonate
Lithium as Add on to every necessary treatment as usual
Placebo as ADD-on to every necessary treatment as usual
S-STS
Change in the clinician administered (S-STS=Sheehan Suicidality Tracking Scale) total score between initial and final visit
Time frame: 5 Weeks
C-SSRS
Change of the total score of C-SSRS (Columbia-Suicide Severity Rating Scale) between start and final visit
Time frame: 5 weeks
The record gives a start of Jan 2014, a primary completion of Mar 2018 and a completion of Jun 2018. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lithium Carbonate
Technische Universität Dresden →