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

Plain Language Summary

Simplified for easier understanding

This study is testing whether lithium, a medication commonly used for mood disorders, can rapidly reduce suicidal thoughts in people who are at a critical time of risk. The ALiAS Trial (Adjunctive Lithium for Acute Suicidality) is run out of Royal North Shore Hospital in Sydney. While lithium is well known for treating mood disorders long-term, researchers want to know if starting it quickly — while someone is still in hospital or just after discharge — can reduce suicidal thoughts faster. Participants receive either lithium or a placebo (a sugar pill) for five weeks, plus their usual treatment. You may be eligible if: - You are aged 18 to 65 years - You have been diagnosed with a mood disorder (such as depression or bipolar disorder) under DSM-5 criteria - You are currently receiving treatment for a mood disorder - You are currently experiencing significant suicidal thoughts (score above 8 on the S-STS scale) - You are not currently taking lithium and your doctor does not plan to prescribe it - You are able to participate and provide written informed consent in English You may NOT be eligible if: - You have used lithium in the past 6 months - You have a personality disorder or substance dependency disorder - You have heart, thyroid, liver, or kidney conditions that make lithium unsafe - You are pregnant, breastfeeding, or could become pregnant and are not using effective contraception - You have participated in another drug trial in the past 12 weeks Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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