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Completed

NCT Number: NCT04410575

Mental Health Assessment and Prescribing by Alberta Pharmacists

This is a clinical trial evaluating the experimental intervention of enhanced pharmacist care by pharmacists with additional prescribing authorization (APA) in Alberta, for patients newly diagnosed with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).

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Key information

Conditions

Major Depressive Disorder Anxiety Disorders Behavior Depressive Disorder Depressive Disorder, Major Generalized Anxiety Disorder Mental Disorders Mood Disorders Personal Satisfaction Pharmacist-Patient Relations Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

About this study

Primary objective

-To evaluate the effect of enhanced pharmacist care possible by community pharmacists with APA in comparison with usual care (standard pharmacist care and physician care) for patients with MDD and/or GAD initiated on pharmacotherapy, with focus on interventions that include:

i) monitoring (lab ordering and interpretation, clinical monitoring of MDD and GAD) ii) patient education iii) referral facilitation (in collaboration with prescribing physician) iv) prescribing (dose adjustment and the addition of adjunctive medication)

Secondary objectives

  • To evaluate the effect of APA pharmacist interventions on:

i)Clinical:

  • The rate of achieving clinical response and remission of MDD and/or GAD compared to usual care (using PHQ-9/GAD-7)
  • Change in the mean PHQ-9 and GAD-7 score
  • Cognitive and functional impairment related to MDD and/or GAD
  • The occurrence of relapse of depression and/or anxiety
  • The proportion of patients receiving appropriate and optimized depression and anxiety medication
  • Patient complaints and/or experiences of medication-related side effects during treatment for MDD and/or GAD (i.e. GI intolerance, dizziness, weight gain)

ii) Process:

  • The impact of the interventions on patient satisfaction and quality of life impact (Patient survey)
  • Assure sustainability by exploring enabling (i.e. pharmacist reimbursement framework) and potential barrier forces (i.e. pharmacist training in managing patients with MDD and GAD)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥ 18 years of age) newly diagnosed with MDD and/or GAD, including:
  • Patients starting on medications for the management of adults with MDD
  • Patients starting on medications for the management of GAD

Exclusion criteria

  • Pregnancy
  • Non-Alberta residents
  • Unwilling or unable to participate in regular follow-up visits
  • Unwilling to participate/sign consent form
  • ≥2 suicide attempts per year
  • Severe, psychotic, and catatonic depression
  • History of and/or current substance abuse, intoxication, addiction or withdrawal
  • Patients diagnosed with comorbid anxiety disorders other than GAD, including: panic -disorder, agoraphobia, specific phobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder
  • Patients diagnosed with comorbid depressive disorder other than MDD, including: depressive disorder due to another medical condition (e.g. hypothyroidism, MS, OSA, -Parkinsons, stroke, TBI, Vitamin B12 insufficiency, Huntington disease, adrenal insufficiency, mononucleosis, systemic lupus erythematosus), adjustment disorder with depressed mood
  • Patients diagnosed with concurrent ADHD, bipolar disorder, schizophrenia and schizoaffective disorder

Treatment and study plan

Standard Pharmacist Care

Other

Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)

Reviewed Questionnaire tool results with participant

Other

Pharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment

Patient Clinical Assessment

Other

Pharmacist conducts clinical assessment of the participant's major depressive disorder and/or generalized anxiety, which can include: appearance, current mood, sleeping patterns, mental health, medical history, social history, family history, relationship with others, suicidal ideation, previous suicide attempts or hospitalizations, current employment status

Psychotherapy Referral

Other

Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist

Pharmacist initiated interim telephone follow-up with participant

Other

Interim telephone follow-up conducted by the pharmacist since the last in-person follow-up & a minimum of 1-2 weeks after the last in-person follow-up that involved a dose adjustment, prescribing of adjunctive medication, or discontinuation of therapy (Note: a telephone follow-up does not replace the scheduled in-person follow-up)

Communication update with physician after participant contact

Other

Pharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant

Medication Counselling and Educational Support

Other

Pharmacist provides medication related counselling and educational support to participant

Non-medication Counselling

Other

Pharmacist provides non-medication related counselling and educational support to participant

Identification of drug interaction

Other

Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety

Identification of drug adverse effect

Other

Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety

Identification of severe deterioration

Other

Pharmacist identification of participant severe deterioration (i.e. suicide attempt)

Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing

Other

Pharmacist collaborates, discusses, and makes recommendations to physician re: treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing

Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing

Other

Pharmacist initiated alteration to treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing

Primary outcomes

  1. Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score

    Time frame: 6 months

    Mean score difference in PHQ-9 score from baseline to end of study between intervention (pharmacist intervention + standard pharmacist care) group vs control (standard pharmacist care) group;

    PHQ-9 scores reflect depression severity, ranges from 0-27 (Scores: 0-4 none/minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe)

  2. Mean score difference in Generalized Anxiety Disorder 7-item (GAD-7) score

    Time frame: 6 months

    Mean score difference in GAD-7 score from baseline to end of study between intervention (pharmacist intervention + standard pharmacist care) group vs control (standard pharmacist care) group;

    GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)

Secondary outcomes

  1. Difference in proportion of participants achieving clinically significant treatment response in Patient Health Questionnaire 9-item (PHQ-9) score between pharmacist intervention vs. standard pharmacist care

    Time frame: 6 months

    Clinically significant treatment response for the PHQ-9 is defined as a reduction in PHQ-9 score by at least 50% from baseline;

    PHQ-9 Scores reflect depression severity, ranges from 0-27 (Scores: 0-4 none/minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe)

  2. Difference in proportion of participants achieving clinically significant treatment response in Generalized Anxiety Disorder 7-item (GAD-7) score between pharmacist intervention vs. standard pharmacist care

    Time frame: 6 months

    Clinically significant treatment response for the GAD-7 is defined as a reduction in GAD-7 score by at least 50% from baseline;

    GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)

  3. Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5

    Time frame: 6 months

    Difference in the proportion of participants with MDD to achieve PHQ-9 score <5 (i.e. remission/no depression) between the pharmacist intervention and standard pharmacist care groups

    PHQ-9 scores reflect depression severity; Ranges from 0-27 (Scores: 0-4 none/minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe)

  4. Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5

    Time frame: 6 months

    Difference in the proportion of participants with GAD to achieve GAD-7 score <5 (i.e. remission/no anxiety) between the pharmacist intervention and standard pharmacist care groups;

    GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)

  5. Percentage difference in self-reported safety concerns disclosed by participant to pharmacist partner, between intervention (pharmacist intervention + standard pharmacist care) and control (standard pharmacist care) study groups, during the study period.

    Time frame: 6 months

    The participant discloses to the pharmacist partner at any time during the duration of study, events that fit the description of a safety concern and measured via frequency of occurrence.

    Safety concerns include:

    • Adverse Medication Effects 2) Suicide Ideation/attempt, 3) Causing withdrawal from Study

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Mental Health Assessment and Prescribing by Alberta Pharmacists (MAP-AP)

Acronym: MAP-AP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2020
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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