DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 mortality

Suicide 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017