RELEASE: REdressing Long-tErm Antidepressant uSE in general practice

The RELEASE (REdressing Long-tErm Antidepressant uSE in general practice) intervention has been designed to support people to safely stop antidepressants.

Our program of research on antidepressants

This research will improve Australian health outcomes by decreasing unnecessary and potentially harmful long-term (>12 months) use of antidepressants. The outcomes of our research will include a validated antidepressant discontinuation model and proven implementation strategies, including practical resources where currently there are none, to foster sustainable improvement in primary mental health care and improved outcomes for patients.

Australia has one of the highest rates of antidepressant use in the world with around 1 in 7 Australians taking antidepressants, many of them long-term. Most antidepressants are prescribed in general practice (92%). Many people experience unpleasant withdrawal symptoms when they attempt to stop antidepressants. Antidepressant withdrawal symptoms are common and can be severe. Withdrawal symptoms, including feeling anxious and irritable, are readily misconstrued as 'relapse' or ongoing need for medication contributing to long-term use with associated risks and adverse effects.

The RELEASE intervention has been designed to support shared decision-making and provide step-by-step guidance for slow hyperbolic tapering of antidepressant dose to minimise withdrawal symptoms and enable people to safely stop antidepressants.

Aim

Aim 1) Evaluate the RELEASE antidepressant discontinuation model and associated implementation strategies in the Australian general practice context.

Primary objective: Evaluate RELEASE effectiveness compared to usual care.

Secondary objective: Evaluate RELEASE implementation barriers and enablers, acceptability, feasibility and cost-effectiveness.

Aim 2) Support integration of RELEASE into urban, regional and rural general practice nationally.

Design

This is a 3-arm cluster randomised controlled effectiveness-implementation trial in 28 general practices in south-east Queensland.

Principles

RELEASE is a user-informed multi-modal intervention that targets both general practitioners and patients. RELEASE has the following guiding principles:

All prescribing decisions are made as usual by the GP and patient together.
Empowering patients.
Acceptable and translatable in routine general practice.
Resources developed to raise awareness, prompt medication review, support shared decision-making, and guide safe cessation of long-term antidepressants when there is no clinical indication for continued use.

Recruiting general practices

Practice recruitment has closed.

Patients are only recruited into the study through participating practices.

Timeline

Data collection is expected to be complete by the end of 2025.

Ethical conduct

This study adheres to the Guidelines of the ethical review process of The University of Queensland and the National Statement on Ethical Conduct in Human Research.

The University of Queensland Human Research Ethics Committee approval number: 2022/HE001667.

Whilst you are free to direct questions you may have to our Project Coordinator and Patient Liaison Officer via release.study@uq.edu.au, if you would like to speak to an officer of the University not involved in the study, you may contact the Ethics Coordinators on +617 3365 3924 / +617 3443 1656 or email humanethics@research.uq.edu.au.

Who is funding this research

Medical Research Future Fund (MRFF) 2020 Clinician Researchers: Applied Research in Health - MRFAR000079 (Commonwealth Department of Health).

National Health and Medical Research Council (NHMRC) 2021 Partnership Projects PRC3 – 2015744.

Research leads

Professor Katharine Wallis

Mayne Professor and Head, Mayne Academy of General Practice
Head, General Practice Clinical Unit

Associate Professor Maria Donald

Associate Professor

Research team

Dr Suzanne McDonald

Research Fellow (Health Services Researcher), General Practice Clinical Unit
Sessional Academic, School of Psychology

Karen Thrift

RELEASE GP Liaison Officer
General Practice Clinical Unit

Dr Idin Panahi

RELEASE GP Practice Support Officer
General Practice Clinical Unit

Maryanne Cleetus

RELEASE Senior Research Assistant and Project Coordinator
General Practice Clinical Unit

Mia Slaughter

RELEASE Administration Officer
General Practice Clinical Unit

Tracey Nayler

PhD Student
General Practice Clinical Unit

Collaborating Investigators

Dr Mark Horowitz (Psychiatrist)

Clinical Research Fellow, North East London NHS Foundation Trust; and Honorary
Clinical Research Fellow,
University College London, UK

Professor Joanna Moncrieff (Psychiatrist)

Professor of Critical and Social Psychiatry, University College London, UK;
and Honorary Consultant Psychiatrist,
North East London Foundation NHS Foundation Trust

Professor Rob Ware (Senior Biostatistician)

Menzies Health Institute, Griffith University, Australia

Professor Joshua Byrnes (Senior Health Economist)

Director, Centre for Applied Health Economic, Griffith University, Australia

Associate Investigators

Dr David King

Clinical Senior Lecturer
General Practice Clinical Unit

Related publications

Many people get withdrawal symptoms when they try to stop antidepressants. So how can you safely stop? – Prof Katharine Wallis, The Conversation, 2024
Antidepressant withdrawal should be taken seriously – we’re investigating ways to help people come off the pills – Prof Katharine Wallis, Dr Mark Horowitz, Prof Joanna Moncrieff, The Conversation, 2024

Wallis KA, Elley CR, Hikaka JF, Moyes SA. Process evaluation of the Safer Prescribing and Care for the Elderly (SPACE) cluster randomised controlled trial in New Zealand general practice. J Prim Health Care. 2022;14(3):244-253. doi: 10.1071/HC22052. https://pubmed.ncbi.nlm.nih.gov/36178832/
Wallis KA, Elley CR, Moyes SA, Lee A, Hikaka JF, Kerse NM. Safer prescribing and care for the elderly (SPACE): a cluster randomised controlled trial in general practice. BJGP Open. 2022;6(1). doi:10.3399/bjgpo.2021.0129. https://pubmed.ncbi.nlm.nih.gov/34645654/
Donald M, Partanen R, Sharman L, Lynch J, Dingle GA, Haslam C, van Driel M. Long-term antidepressant use in general practice: a qualitative study of GPs' views on discontinuation. Br J Gen Pract. 2021;71(708). doi: 10.3399/bjgp.2020.0913. https://bjgp.org/content/71/708/e508
Dingle GA, Sharman LS, Haslam C, Donald M, Turner C, Partanen R, Lynch J, Draper G, van Driel ML. The effects of social group interventions for depression: systematic review. J Affect Disord. 2021;281:67-81. doi: 10.1016/j.jad.2020.11.125. https://pubmed.ncbi.nlm.nih.gov/33302192/
Wallis KA, Donald M, Moncrieff J. Antidepressant prescribing in general practice: A call to action. Aust J Gen Pract. 2021;50(12):954-956. doi:10.31128/AJGP-02-21-5828. https://pubmed.ncbi.nlm.nih.gov/34845476/
Wallis KA, Elley CR, Moyes SA, Kerse NM. Safer Prescribing And Care for the Elderly (SPACE): Pilot study in general practice. BJGP Open. 2018;2(3). doi:10.3399/bjgpopen18X101594. https://bjgpopen.org/content/6/1/BJGPO.2021.0129
Wallis KA, Tuckey R. Safer Prescribing and Care for the Elderly (SPACE): feasibility of audit and feedback plus practice mail-out to patients with high-risk prescribing. J Prim Health Care. 2017;9(2):145-152. doi:10.1071/HC17018. https://pubmed.ncbi.nlm.nih.gov/29530226/
Wallis KA, Andrews A, Henderson M. Swimming against the tide: Primary care physicians’ views on deprescribing in everyday practice. Ann Fam Med. 2017;15(4):341-346. doi:10.1370/afm.2094. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5505453/

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