Lithium and Standard Therapy in Resistant Depression

NCT00927550 | Unknown Phase 4 DMC

• 1 other identifier: LAST_RD_FARM77Z3BL-5.1_132009
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

resistant depression; lithium; RCT; lithium therapy; standard therapy

Outcome Measures

Primary Outcomes (1)

• Suicide completion and acts of deliberate self harm (DSH) will constitute the composite primary outcome

  One year

Secondary Outcomes (5)

• All-cause mortality

  One year

• Suicide mortality

  One year

• Deliberate self-harm or attempted suicide

  One year

• Change in severity of depressive symptoms from baseline

  One year

• Adverse reactions during the study

  One year

Study Arms (2)

lithium plus usual care

EXPERIMENTAL

Drug: lithium

usual care without lithium therapy

ACTIVE COMPARATOR

Drug: usual care

Interventions

lithium DRUG

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.

Also known as: Carbolithium

lithium plus usual care

usual care DRUG

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.

usual care without lithium therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

University of Verona

Verona, 37134, Italy

RECRUITING

Related Publications (2)

• Girlanda F, Cipriani A, Agrimi E, Appino MG, Barichello A, Beneduce R, Bighelli I, Bisoffi G, Bisogno A, Bortolaso P, Boso M, Calandra C, Cascone L, Castellazzi M, Corbascio C, Parise VF, Gardellin F, Gennaro D, Hanife B, Lintas C, Lorusso M, Luca A, Luca M, Luchetta C, Lucii C, Maio F, Marsilio A, Mattei C, Moretti D, Nose M, Occhionero G, Papanti D, Pecile D, Percudani M, Prestia D, Purgato M, Restaino F, Romeo S, Sciarma T, Strizzolo S, Tamborini S, Todarello O, Tozzi F, Ziero S, Zotos S, Barbui C. Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: results and lessons of an underpowered randomised clinical trial. BMC Res Notes. 2014 Oct 17;7:731. doi: 10.1186/1756-0500-7-731.

  PMID: 25326163 DERIVED

• Cipriani A, Girlanda F, Agrimi E, Barichello A, Beneduce R, Bighelli I, Bisoffi G, Bisogno A, Bortolaso P, Boso M, Calandra C, Cascone L, Corbascio C, Parise VF, Gardellin F, Gennaro D, Hanife B, Lintas C, Lorusso M, Luchetta C, Lucii C, Cernuto F, Tozzi F, Marsilio A, Maio F, Mattei C, Moretti D, Appino MG, Nose M, Occhionero G, Papanti D, Pecile D, Purgato M, Prestia D, Restaino F, Sciarma T, Ruberto A, Strizzolo S, Tamborini S, Todarello O, Ziero S, Zotos S, Barbui C. Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: a protocol for a randomised, independent, pragmatic, multicentre, parallel-group, superiority clinical trial. BMC Psychiatry. 2013 Aug 13;13:212. doi: 10.1186/1471-244X-13-212.

  PMID: 23941474 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Lithium

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Michele Tansella, MD, Professor of psychiatry

  Universita di Verona

  STUDY CHAIR

Central Study Contacts

corrado barbui, MD

CONTACT

+39 0458126418; corrado.barbui@univr.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 17, 2009

Record last verified: 2009-09

Locations

IT (1)