Scientific Advisory Committee on Mental Health Disorders: Consensus statements

On this page

• Overview
• Statements
  • Importance of psychiatric assessment
  • Treatment resistance requires demonstrated optimization
  • Importance of clinical setting in the treatment of psychiatric emergencies
  • Access
  • Investigational therapies require evidentiary and ethics safeguards
  • Established interventional treatments are underused
  • Business models
  • Innovation

Overview

Health Canada’s Scientific Advisory Committee on Mental Health Disorders (SAC-MHD) provides expert advice on current Canadian standards for assessing and treating mental health disorders. These include mood, anxiety, substance and addiction, and trauma- and stressor-related disorders.

The committee held 3 virtual sessions, for a total of 17 hours, on December 3, 2025, January 28, 2026, and April 9, 2026. The sessions focused on the current standard of care for major depressive disorder and treatment-resistant depression.

The committee discussed:

• diagnostic criteria
• established treatment pathways
• management of suicide risk and comorbidities
• the evolving role of investigational therapies

Also discussed were psychedelic-assisted therapies, with a focus on their current evidence base and place in clinical practice, as well as the complexities of existing access pathways.

The committee used a structured Delphi method to develop expert consensus statements. Members provided their feedback anonymously in 2 rounds, to refine input and achieve consensus.

Each consensus statement has a corresponding consideration, which reflects key discussion points and supporting context.

Statements

1. Importance of psychiatric assessment

Comprehensive psychiatric assessment is essential before investigational or novel interventions are considered for depressive disorders, particularly in individuals requiring assessment for treatment resistance who did not benefit from multiple prior optimized treatment trials.

Considerations

Diagnostic reassessment, confirmation of optimization (dose, duration, adherence) of past treatment trials and evaluation of comorbidities are important for determining treatment resistance and identifying appropriate clinical interventions. This approach aligns with the guidelines of the Canadian Network for Mood and Anxiety Treatments (CANMAT) and the American Psychiatric Association (APA), as well as other major international frameworks.

Although psychiatric assessments are not necessarily limited to psychiatrists, the involvement of a psychiatrist is strongly recommended. It is also appropriate, especially when an investigational or unapproved drug is being considered for a patient with treatment-resistant depression (TRD).

While access to virtual psychiatric consultation varies across jurisdictions, primary care providers may be able to obtain input from a specialist through centralized referral systems, rapid-response advice lines or time-limited consultations. Availability and wait times will vary.

2. Treatment resistance requires demonstrated optimization

Treatment resistance, especially for depression, cannot be established without clear documentation of optimized, evidence-based pharmacological and psychotherapeutic interventions. These include information on dose, duration, adherence, response and biopsychosocial/cultural context.

Considerations

The terms “treatment-resistant depression” (TRD), “difficult-to-treat depression” (DTD) and “refractory depression” are widely used. However, no consensus definition with demonstrated predictive utility for clinical decision-making currently exists. A systematic review of high-quality guidelines found that only 2 of 7 guidelines included a specific TRD definition with no convergent therapeutic strategy between them. Consistent with this lack of consensus, the CANMAT 2023 guidelines note that TRD is most frequently defined as failure to respond to two or more adequate antidepressant trials, while also recognizing that this categorical threshold has important limitations. Rather than relying on a single failure threshold, CANMAT 2023 proposes DTD as a broader framework for persistent inadequate response and emphasizes measurement-based care, early identification of non-response, and treatment adjustment based on response and tolerability.

Practitioner submissions to the Special Access Program (SAP) showed recurrent deficiencies and did not adequately document key elements of treatment optimization. For example, gaps observed include:

• lack of evidence of dose optimization and adequate trial duration
• limited documented use of augmentation or combination strategies
• lack of appropriately administered, evidence-based psychotherapeutic interventions
• absence of measurement-based care to assess treatment response

These gaps limit the ability to determine whether difficult to treat or treatment-resistant depression is present. That would include the need for reassessing diagnosis and comprehensive treatment history.

Before investigational pharmacological or unapproved treatment options are considered, the clinician should ensure that:

• evidence-based pharmacological and psychotherapeutic treatments, including their combinations, have been tried and
• pharmacotherapies were of adequate dose and duration

3. Importance of clinical setting in the treatment of psychiatric emergencies

Psychiatric emergencies should be managed in an appropriate clinical setting and should involve established evidence-based therapies for treatment.

Considerations

The determination of a psychiatric emergency should be grounded in clinical severity and risk assessment (for example, risk of harm to self or others). Level of care must be aligned to this to safely care for the patient.

Outpatient clinics are not appropriate settings for managing psychiatric emergencies.

In general, true psychiatric emergencies should be managed in settings where there is:

• appropriate oversight and capacity (for example, emergency departments or inpatient units)
• timely access to interdisciplinary care and monitoring

Serious and life-threatening conditions may require a range of evidence-based interventions (for example, pharmacologic treatments), as well as access to specialized psychiatric care and supportive services.

4. Access

Criteria under SAP are relevant to mental health disorders but may be difficult to apply without rigorous and individualized assessment that includes psychiatric evaluation and proof of treatment resistance.

Considerations

“Serious” and “life threatening” may be interpreted in different ways, particularly as they relate to psychiatric conditions and the management of risk over time.

The committee strongly emphasized the need for rigour in assessment and monitoring to determine treatment response and treatment resistance, especially in mood disorders or other chronic recurring conditions. Diagnostic accuracy and confirmed treatment resistance could support consistency in decision-making and reduce the risk of inappropriate treatments. In this context, focusing on whether the diagnosis is well-established and whether the condition is genuinely treatment resistant despite optimized care is important. Management may also depend on the time horizon for suicide risk, which may be imminent, short-term or long-term.

5. Investigational therapies require evidentiary and ethics safeguards

Investigational treatments, including psychedelic-assisted therapies, should only be considered after exhaustion of established options and within settings that ensure appropriate expertise, oversight and patient protection.

Considerations

The premature use of investigational therapies is a concern, as there is limited evidence of their safety and effectiveness in high-risk or complex patient populations. Another concern is that the promotion of emerging investigational therapies could result in such therapies being pursued ahead of or replacing established evidence-based care.

Investigational therapies should be reserved for use by appropriately qualified practitioners. They should take place in specialized settings that support clinical oversight, patient safety and continuity of care. Where possible, they should also be pursued within a research context, such as a clinical trial, with exceptional access pathways reserved for special circumstances. Before considering investigational options, there should be clear documentation that evidence-based treatments for a specific indication have been appropriately trialed.

Ongoing monitoring and outcome reporting, supported by measurement-based care, were also identified as important to supporting patient safety and strengthening the evidence base.

6. Established interventional treatments are underused

Repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT) are evidence-based treatments for major depressive disorder and treatment-resistant depression. However, access and acceptability remain constrained by systemic, logistical and patient-level barriers.

Considerations

rTMS is becoming more available in specialized outpatient settings, and ECT is being offered in inpatient or highly controlled clinical environments in most jurisdictions. More recently, IV ketamine and intranasal esketamine have been considered in cases of treatment resistance.

While these treatments are recognized as effective, funding, stigma, geographic access and service availability barriers are limiting their use.

Rather than considering investigational options first, it’s important to increase access to these recognized treatments. Shared care models and virtual consultation mechanisms, such as e-consults, were identified as important tools to support timely psychiatric input, rational prescribing and treatment optimization.

7. Business models

Business models using direct-to-consumer marketing of unsubstantiated claims or a templated approach to promote access to experimental medication may divert patients away from established treatments and research-based treatments of experimental medications. This may therefore expose them to related risks.

Considerations

Some business models may disproportionately target vulnerable individuals. There is a risk that patients may be directed toward experimental therapies before evidence-based therapies have been adequately optimized. Experimental therapies may also inadvertently bypass or short-circuit established clinical pathways, including access to appropriate first-, second- and third-line treatments.

Patients may not consistently receive structured psychoeducation on stepwise care and the full range of established treatments that are available before they pursue experimental therapies. This may result in misaligned expectations on a therapy’s benefits and risks. It also highlights the importance of ensuring that decision-making is informed and clinically grounded.

8. Innovation

Innovative therapies are greatly needed. The committee encourages research where possible, including Open Label Individual Patient (OLIP) clinical trials.

Considerations

High-quality clinical research is essential to generate reliable evidence on the safety and effectiveness of investigational therapies, including psychedelic-assisted treatments. Clinical trials are important mechanisms as they help to generate evidence, especially in areas of unmet clinical need.

Strengthening the evidence base is crucial to informing clinical practice and enabling appropriate integration of novel therapies into the health care system. The importance of advancing innovation within frameworks that ensure scientific rigour, patient safety and ethical oversight is underscored.