Flow Clinician Overview

Treat Depression.

Differently.

Indication

Class IIa medical device approved for the treatment of unipolar major depressive disorder (MDD) in adults, either as monotherapy or as an adjunct with antidepressants and psychological therapies.

Mechanism of action

The Flow headset delivers a gentle 2mA electric current (transcranial Direct Current Stimulation, tDCS) to the left dorsolateral prefrontal cortex.

This region is crucial for emotional regulation and is often hypoactive in individuals with depression. DCS enhances neuronal activity in this area, counteracting hypoactivity, improving mood and emotional regulation.

Efficacy

Results at 10 weeks from a multisite, double-blind placebo-controlled randomised superiority trial were statistically significant for both primary and secondary endpoints. Flow achieved a 57.5% remission rate using the MADRS scale and was eﬀective as both standalone and adjunctive therapy.

Open-label patient cohort study in an NHS primary care general practice found at 6 weeks: 2

58.1% of patients showed reliable improvement, and 32.3% achieved remission using the PHQ-9
Significant improvements were observed in functioning (WSAS) and health-related quality of life (EQ-5D-5L)

Improvements in Depression Severity and Functional Impairment

Treatment schedule

The standard treatment is split into 2 phases – activation and strengthening. Each session (termed stimulation) is 30 minutes long. Patients complete a MADRS-s survey at the beginning of each week to monitor progress.

Activation Phase
Weeks 1-3

Includes 5 stimulations a week
Introduces optional behavioral therapy courses via the app

Strengthening Phase:
Week 4 onwards

Includes up to 2 stimulations a week
Continues to strengthen and preserve results
Continue behavioural therapy courses

Behavioural therapy

The Flow app includes 7 behavioural therapy courses including behavioural activation, exercise, meditation, diet, and sleep hygiene, totalling over 50 short therapy sessions. These courses are entirely optional and do not interfere with the Flow stimulation protocol.

Contraindications

No universal contraindications.

Warnings and Precautions

Broken/inflamed/infected skin (including, for example, psoriasis) at the electrode site
Cranial or intracranial implant (e.g. brain clips, deep brain stimulators)
Craniofacial abnormalities (e.g., congenital deformities, severe trauma, or reconstructive surgeries) which may aﬀect electrode placement
Epilepsy or history of seizures
Active suicidal ideation (requires closer monitoring)
History of hypomania or mania (may require closer monitoring)

Special populations

Other chronic conditions: No known interactions with medications; used by individuals with diabetes, heart disease, hypertension, asthma, co- occurring mental health conditions, neurodivergence, and brain injuries/ disorders without reported safety concerns.
Pregnancy: Not licensed for use; no safety concerns identified in existing studies, research ongoing.
Breastfeeding: Safe to use; no eﬀect on breast milk production.
Postpartum: Appears safe for postpartum depression and successfully used in NHS pilots.
Children and Adolescents: Not licensed for use; studies ongoing for ages 14+

Adverse reactions

Based on real world evidence from >20,000 users, the incidence rate of adverse reactions is 4.5%, which is favourable against antidepressants.

Adverse events should be reported.
Please report to Aurora BioScience Pty Ltd by emailing customerservice@aurorabioscience.com.au

Clinical review and customisation

Review your patients’ progress and adherence through the Flow Clinician Platform (CPP). Accessible anytime and anywhere through a secure web browser, this platform streamlines patient visits by providing informed insights. It also allows for the customisation of treatment protocols (maximum 1 per day, 7 per week) based on clinical judgement to address individual patient needs. This setup ensures personalised treatment adjustments to help optimise patient outcomes.

The suggested initial treatment duration is 10 weeks. Following 10 weeks, patients’ response should be assessed and length of continued treatment determined, taking into consideration the eﬀectiveness to date and the risk of relapse.

Support and contact Information

For technical support and assistance, patients can contact service@aurorabioscience.com.au
Clinicians can enquire about setup, pricing, and training support by contacting info@aurorabioscience.com.au