Suicidal Ideation/BehaviorNCT02039479
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
A study testing Lithium Carbonate in people with Suicidal Ideation/Behavior and Depression, run by Technische Universität Dresden at 5 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation/Behavior, Depression
- What is being tested?
- Lithium Carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 5 sitesGermany
- Study dates
- Jan 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Psychiatrie, Verhaltensmedizin und Psychosomatik
Chemnitz, 09116
Thomas Barth, MD, t.barth@skc.de
- Not yet recruiting
Dept. of Psychiatry and Psychotherapy, Hospital of Dresden Neustadt
Dresden, Saxony, 01324
Burkhard Jabs, Prof, +49 351 856 69 ext. 02, burkhard.jabs@khdh.de
Burkhard Jabs, Prof.
- Recruiting
Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt
Frankfurt am Main, 60528
Andreas Reif, Prof., 069 / 6301-5222, andreas.reif@kgu.de
- Recruiting
Psychatrie Universitätsmedizin Göttingen
Göttingen, 37075
Sarah Trost, MD, s.trost@med.uni-goettingen.de
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69115
Oliver Gruber, Prof., oliver.gruber@med.uni.heidelberg.de
About this study
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.
Read the 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.
- Conditions
- Suicidal Ideation/Behavior, Depression
- Being tested
- Lithium Carbonate, Placebo
- Keywords
- anti-suicide, Lithium, Depression, suicidal Ideation/behavior
- Medical subject headings
- Suicidal Ideation, Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium CarbonateDrug
Lithium as Add on to every necessary treatment as usual
PlaceboDrug
Placebo as ADD-on to every necessary treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| TAU + Placebo | Placebo comparator | Treatment as Usual + Placebo Receives: Drug: Placebo |
| TAU + Lithium | Active comparator | Treatment as Usual + Lithium Receives: Drug: Lithium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-STS
Change in the clinician administered (S-STS=Sheehan Suicidality Tracking Scale) total score between initial and final visit
Measured: 5 Weeks
Secondary outcomes (1)
C-SSRS
Change of the total score of C-SSRS (Columbia-Suicide Severity Rating Scale) between start and final visit
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal Ideation/BehaviorStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Bauer, Prof., Principal investigator, Dept. of Psychiatry and Psychotherapy; TU DresdenUte Lewitzka, MD, Study director, Dept. of Psychiatry and Psychotherapy, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039479
- Sponsor's protocol ID
- 01KG1307
- Status last verified
- Mar 2018
- First submitted
- 16 Jan 2014
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25986590
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02039479
- Acronym / sponsor ID
- 01KG1307
- Conditions
- Suicidal Ideation/Behavior, Depression
- Keywords
- anti-suicide, Lithium, Depression, suicidal Ideation/behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + Placebo | Placebo comparator | Drug: PlaceboTreatment as Usual + Placebo |
| TAU + Lithium | Active comparator | Drug: Lithium CarbonateTreatment as Usual + Lithium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium CarbonateLithium as Add on to every necessary treatment as usual | Drug | TAU + Lithium |
| PlaceboPlacebo as ADD-on to every necessary treatment as usual | Drug | TAU + Placebo |
Primary outcome
S-STS
Time frame: 5 Weeks
Change in the clinician administered (S-STS=Sheehan Suicidality Tracking Scale) total score between initial and final visit
1 secondary outcome
C-SSRS
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Derived from this study: PubMed 25986590Lewitzka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bauer, Prof. principal investigator
Dept. of Psychiatry and Psychotherapy; TU Dresden
Ute Lewitzka, MD study director
Dept. of Psychiatry and Psychotherapy, TU Dresden
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithium Carbonate in people with Suicidal Ideation/Behavior and Depression, run by Technische Universität Dresden at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Bauer, Prof. (+49 351 458 ext. 2760, michael.bauer@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S-STS (time frame: 5 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02039479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.