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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
MAP-AP Trial 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.Check my eligibility
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.See study design
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.
MAP-AP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreMAP-AP 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
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,040 Total Patients Enrolled
Yazid Al Hamarneh, BSc (Pharm), PhD, CDMPrincipal InvestigatorUniversity of Alberta
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot commit to regular follow-up visits.I have severe depression with psychosis or catatonia.I am not willing to sign the consent form for the trial.I am an adult newly diagnosed with depression or anxiety and starting treatment.I have been diagnosed with a depressive disorder not classified as MDD.I have been diagnosed with an anxiety disorder that is not GAD.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
- Group 2: Control Group (Standard Pharmacist Care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the desired outcome of this clinical experiment?
"This clinical trial's primary outcome, assessed over a 6 month period, will be the difference in Patient Health Questionnaire 9-item (PHQ-9) scores. Secondary objectives include determining if participants with Generalized Anxiety Disorder (GAD) achieved remission via a Generalized Anxiety Disorder 7-item (GAD-7) score <5; measuring anxiety severity using GAD-7 which ranges from 0 to 21; ascertaining the proportion of Major Depressive Disorder and/or GAD patients achieving British Columbia Cognitive Complaints Inventory (BC-CCI), ranging from 0 to 18, that is below 5; and percentage difference between"
Answered by AI
Is this research endeavor seeking participants at the moment?
"According to clinicaltrials.gov, this medical study is not presently recruiting; the last update was on October 3rd 2022 and it was originally posted on December 10th 2021. However, 2290 other trials are actively searching for suitable applicants at present."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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