Lithium and Standard Therapy in Resistant Depression
Information source: Universita di Verona
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: lithium (Drug); usual care (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Universita di Verona Official(s) and/or principal investigator(s): Michele Tansella, MD, Professor of psychiatry, Study Chair, Affiliation: Universita di Verona
Overall contact: corrado barbui, MD, Phone: +39 0458126418, Email: corrado.barbui@univr.it
Summary
The principal clinical question is whether lithium is effective in reducing the risk of
suicidal behaviour in subjects with treatment-resistant depression and suicide risk.
Additionally aims of the study are: (a) to assess whether lithium is effective in improving
depressive symptomatology in subjects with treatment-resistant depression and suicide risk;
(b) to assess the tolerability profile of lithium.
Clinical Details
Official title: Randomized Evaluation of the Effectiveness of Lithium in Subjects With Treatment-Resistant Depression and Suicide Risk. An Independent, Pragmatic, Multicentre, Parallel-Group, Superiority Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Suicide completion and acts of deliberate self harm (DSH) will constitute the composite primary outcome
Secondary outcome: All-cause mortalitySuicide mortality Deliberate self-harm or attempted suicide Change in severity of depressive symptoms from baseline Adverse reactions during the study
Detailed description:
Inclusion criteria:
1. Diagnosis of major depression (clinical diagnosis, guided by DSM-IV criteria).
2. History of attempted suicide or deliberate self-harm in the previous 12 months.
3. Inadequate response to at least two antidepressants given sequentially at an adequate
dose for an adequate time for the current depressive episode.
4. Uncertainty about which treatment arm would be best for the participant.
5. Age 18 or above.
6. Agreement between investigator and patient to enter the study.
Exclusion criteria:
1. In addition to major depression, a primary diagnosis of any concurrent Axis I disorder
(according to DSM-IV criteria) will constitute an exclusion criterion; by contrast, any
concurrent Axis II disorder (according to DSM-IV criteria) will not constitute an
exclusion criterion.
2. Previous exposure to lithium was associated with lack of efficacy or unwanted adverse
reactions.
3. Clinical conditions contraindicate the experimental treatment arm (for example thyroid
or kidney disease or abnormalities).
4. Pregnant/lactating women.
5. Women of childbearing potential not practicing a reliable method of contraception.
PRIMARY OUTCOME DEFINITION
Suicide completion and acts of deliberate self harm (DSH) will constitute the composite
primary outcome. The term "suicide" is defined as an act with a fatal outcome, deliberately
initiated and performed by the person with the knowledge or expectation of its fatal
outcome.
DSH is defined as intentional self-poisoning or self-injury, irrespective of motivation.
Self-poisoning includes the intentional self-ingestion of more than the prescribed amount of
any drug, whether or not there is evidence that the act was intended to result in death.
This also includes poisoning with non-ingestible substances and gas, overdoses of
"recreational drugs" and severe alcohol intoxication where clinical staff consider such
cases to be an act of intentional self-harm (rather than recreational binge drinking).
Self-injury is defined as any injury that has been intentionally self-inflicted, including
self-cutting. The intention to end life may be absent or present to a variable degree. Other
terms used to describe this phenomenon are "attempted suicide" and "parasuicide". Some acts
of DSH are characterised by high suicidal intent, meticulous planning (including precautions
against being found out), and severe lethality of the method used. Other acts of DSH are
characterised by no or low intention of suicide, lack of planning and concealing of the act,
and low lethality of the method used.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of major depression (clinical diagnosis, guided by DSM-IV criteria).
- History of attempted suicide or deliberate self-harm in the previous 12 months.
- Inadequate response to at least two antidepressants given sequentially at an adequate
dose for an adequate time for the current depressive episode.
- Uncertainty about which treatment arm would be best for participant.
- Age 18 or above.
- Agreement between investigator and patient to enter the study.
Exclusion Criteria:
- In addition to major depression, a primary diagnosis of any concurrent Axis I
disorder (according to DSM-IV criteria) will constitute an exclusion criterion; by
contrast, any concurrent Axis II disorder (according to DSM-IV criteria) will not
constitute an exclusion criterion.
- Previous exposure to lithium was associated with lack of efficacy or unwanted adverse
reactions.
- Clinical conditions contraindicate the experimental treatment arm (for example
thyroid or kidney disease or abnormalities).
- Pregnant/lactating women.
- Women of childbearing potential not practicing a reliable method of contraception.
Locations and Contacts
corrado barbui, MD, Phone: +39 0458126418, Email: corrado.barbui@univr.it
University of Verona, Verona 37134, Italy; Recruiting Corrado Barbui, MD, Email: corrado.barbui@univr.it Andrea Cipriani, MD, Principal Investigator Corrado Barbui, MD, Principal Investigator Michela Nosè, MD, Principal Investigator Marianna Purgato, Psychologist, Principal Investigator Francesca Girlanda, Psychologist, Principal Investigator Eleonora Esposito, MD, Principal Investigator
Additional Information
Starting date: June 2009
Last updated: September 15, 2009
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