Lithium and Standard Therapy in Resistant Depression (LAST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Universita di Verona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00927550
First received: June 24, 2009
Last updated: September 15, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Depression
Drug: lithium
Drug: usual care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Suicide completion and acts of deliberate self harm (DSH) will constitute the composite primary outcome [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Suicide mortality [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Deliberate self-harm or attempted suicide [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Change in severity of depressive symptoms from baseline [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Adverse reactions during the study [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lithium plus usual care Drug: lithium
Patients allocated to lithium will be administered an oral starting dose ranging between 150 and 300 milligrams. Suggested final oral dose will have to achieve plasma levels of 0.4 to 1.0 mmol/L. Clinicians will be free of increasing or decreasing the dose according to clinical status and circumstances. Dose changes will be recorded. Following randomization, treatment is to be taken daily for 1 year unless some clear reason to stop develops. Patients allocated to the lithium arm will receive usual pharmacological and non-pharmacological treatment as clinically indicated. Any other pharmacological treatment will be allowed.
Other Name: Carbolithium
Active Comparator: usual care without lithium therapy Drug: usual care
Patients allocated to the control arm will receive usual pharmacological and non-pharmacological treatment as clinically indicated. Patients allocated to the control arm will not be allowed to receive lithium. Any other pharmacological treatment will be allowed.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927550

Contacts
Contact: corrado barbui, MD +39 0458126418 corrado.barbui@univr.it

Locations
Italy
University of Verona Recruiting
Verona, Italy, 37134
Contact: Corrado Barbui, MD       corrado.barbui@univr.it   
Principal Investigator: 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         
Sponsors and Collaborators
Universita di Verona
Investigators
Study Chair: Michele Tansella, MD, Professor of psychiatry Universita di Verona
  More Information

No publications provided by Universita di Verona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corrado Barbui MD, University of Verona
ClinicalTrials.gov Identifier: NCT00927550     History of Changes
Other Study ID Numbers: LAST_RD_FARM77Z3BL-5.1_132009
Study First Received: June 24, 2009
Last Updated: September 15, 2009
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Universita di Verona:
resistant depression
lithium
RCT
lithium therapy
standard therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014