RecruitingPhase 4ACTRN12618000106235

The ALiAS Trial: Examining the potential for lithium treatment to help patients with suicidality

The Adjunctive Lithium for Acute Suicidality (ALiAS) Trial: A randomised controlled trial examining the effect of adjunctive lithium on acute suicidality in patients with a mood disorder


Sponsor

The University of Sydney

Enrollment

120 participants

Start Date

Mar 1, 2018

Study Type

Interventional

Conditions

Summary

The Adjunctive Lithium for Acute Suicidality (ALiAS) Trial is an Australian Rotary Health supported project lead by Professor Gin Malhi at the CADE Lithium Clinic, Royal North Shore Hospital (Sydney, NSW) and The Northside Clinic (Sydney, NSW). With a team of international and local collaborators, researchers will conduct a clinical trial sponsored by the University of Sydney. Lithium is a medication that has been in use for many years for the treatment of mood disorders. It is typically prescribed once a patient is out of hospital, and as such, little is known about whether it can produce specific antisuicidal benefits that can be harnessed more rapidly (e.g. while patients are still in hospital or at other critical times), though early findings are providing some clues. The ALiAS trial will determine whether added lithium treatment can produce early antisuicidal benefits, and whether these benefits can be sustained during the at risk period, which is in hospital and just after discharge. Patients from an inpatient unit and the community will be referred and screened, and suitable patients will be randomly allocated receive five weeks of lithium or placebo treatment, in addition to treatment as usual. Patients and selected researchers will not be aware of whether the patient is receiving lithium or placebo treatment. Patients will be monitored regularly and will be assessed weekly either in hospital or at the CADE Lithium Clinic. The weekly assessment will include a blood test, answering researcher administered questionnaires, completing self-report questionnaires, and a clinical consultation where the patient’s lithium levels will be examined and following week's medication will be prescribed. The primary outcome measure is suicidality, which we expect to reduce more rapidly and to a greater extent over the five weeks in the lithium treated group, in comparison to the placebo treated group.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria8

  • Participants will be eligible to take part in the ALiAS Trial if they are:
  • Aged 18-65 years
  • Meet DSM-5 criteria for a mood disorder
  • Currently receiving treatment for a mood disorder
  • Presenting with suicidality as defined by a score of greater than 8 on the S-STS scale
  • Not currently receiving lithium treatment and their treating doctor does not intend to prescribe lithium during the course of the study
  • Willing and able to comply to the trial protocol in English
  • Willing and able to give written informed consent in English

Exclusion Criteria7

  • Participants will be not be eligible to take part in the ALiAS Trial if they:
  • Are not receiving treatment for a mood disorder
  • Have used lithium in the past 6 months
  • Meet criteria for personality disorder or substance dependency disorder in accordance with DSM-5 criteria
  • Have contraindication for lithium therapy including heart conditions, thyroid, hepatic, renal dysfunction (as checked by blood tests)
  • Are pregnant (as checked by blood test) or breastfeeding or are of child-bearing potential and not willing to use effective contraception
  • Have participated in another research trial involving an investigational medical product in the past 12 weeks

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Interventions

The ALiAS Trial is a 5-week randomised, double-blind, placebo-controlled treatment trial. During the trial participants will receive treatment as usual with either lithium carbonate or placebo prescri

The ALiAS Trial is a 5-week randomised, double-blind, placebo-controlled treatment trial. During the trial participants will receive treatment as usual with either lithium carbonate or placebo prescribed as an adjunctive treatment. Treatment as usual is defined as treatment as directed by the treating doctor of the participant. Lithium will be prescribed in addition to treatment as usual for 5 weeks, allowing one week to titrate doses to achieve a suitable lithium plasma concentration level (typically 0.6-0.8 mmol/L). Therefore there will be 1 week of titration and up to 4 weeks of lithium therapy at a stable dose. Dose: The dose will be variable for each participant and dependent on their lithium plasma concentration measured by weekly blood tests. In the titration week daily doses will increase from 250mg (Day 1) to 1250mg (Day 7). At the end of the titration week, all participants will undergo a blood test and their prescribed dosage for the following week will be dependent on whether the participant has reached a suitable level. Typically patients will be prescribed between 1000mg and 1500mg per day, but no more than 2000mg per day. Duration: Participants will participate in the trial and will receive adjunctive lithium therapy or placebo for a total of 5 weeks. Mode: The lithium tablets are administered orally with water after a meal at 20:00 (8:00pm) each night. Adherence: Trial medication adherence for participants that are outpatients will be measured by participant self-report and will be reflected in the blood tests. For participants that are involved in the study while they are inpatients at The Northside Clinic, the nursing staff will record trial medication adherence, and adherence will also be validated by blood test results.


Locations(2)

Royal North Shore Hospital - St Leonards

NSW, Australia

Northside Clinic Private Hospital - Greenwich

NSW, Australia

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ACTRN12618000106235


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