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Pharmacist Care for Mental Health (MAP-AP Trial)

N/A

Recruiting

Led By Yazid Al Hamarneh, BSc (Pharm), PhD, CDM

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Unwilling or unable to participate in regular follow-up visits

Severe, psychotic, and catatonic depression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether extra help from pharmacists can improve care for people with depression and anxiety.

Who is the study for?

This trial is for adults over 18 in Alberta who've just been diagnosed with Major Depressive Disorder or Generalized Anxiety Disorder and are starting medication. It's not for those with a history of substance abuse, other mental health conditions like bipolar disorder, severe depression types, multiple suicide attempts, pregnant individuals, or non-residents.

What is being tested?

Pharmacists with special prescribing rights are testing an enhanced care approach for managing new cases of depression and anxiety. This includes assessing patients' mental health, adjusting medications if needed, providing counseling support, identifying drug side effects or interactions, and coordinating closely with physicians.

What are the potential side effects?

Since this trial involves various interventions rather than specific medications being tested directly for side effects aren't the main focus here. However, any medication adjustments made by pharmacists could potentially lead to typical antidepressant or anti-anxiety medication side effects such as nausea, dizziness, sleep disturbances or mood changes.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot commit to regular follow-up visits.

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I have severe depression with psychosis or catatonia.

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I am not willing to sign the consent form for the trial.

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I have been diagnosed with an anxiety disorder that is not GAD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)Experimental Treatment13 Interventions

Participants enrolled in the intervention group will receive pharmacist interventions, in addition to standard care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians), at enrollment (month 0) and at 1, 3, and 6 month in-person follow-up appointments

Group II: Control Group (Standard Pharmacist Care)Active Control7 Interventions

Patients randomized to the usual care group will receive standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians) and physician care, at enrollment (month 0) with no specific interventions for the duration of 6 months, until the 6 month in-person follow-up appointment

0 / 4Eligibility criteria met