Major Depressive DisorderMAP-APNCT04410575
Mental Health Assessment and Prescribing by Alberta Pharmacists
A study testing Standard Pharmacist Care, Reviewed Questionnaire tool results with participant and Patient Clinical Assessment in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by University of Alberta at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Generalized Anxiety Disorder, Pharmacist-Patient Relations
- What is being tested?
- Standard Pharmacist Care, Reviewed Questionnaire tool results with participant and Patient Clinical Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 22 Mar 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health Assessment and Prescribing by Alberta Pharmacists (MAP-AP)
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).
Read the detailed description
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:
- 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)
- Being tested
- Standard Pharmacist Care, Reviewed Questionnaire tool results with participant, Patient Clinical Assessment, Psychotherapy Referral, Pharmacist initiated interim telephone follow-up with participant
- Keywords
- Pharmacist, Prescribing, Major Depressive Disorder, Generalized Anxiety Disorder, Mental Health, Intervention, Expanded Scope
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Pharmacist CareOther
Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)
Reviewed Questionnaire tool results with participantOther
Pharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment
Patient Clinical AssessmentOther
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 ReferralOther
Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist
Pharmacist initiated interim telephone follow-up with participantOther
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 contactOther
Pharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant
Medication Counselling and Educational SupportOther
Pharmacist provides medication related counselling and educational support to participant
Non-medication CounsellingOther
Pharmacist provides non-medication related counselling and educational support to participant
Identification of drug interactionOther
Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety
Identification of drug adverse effectOther
Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety
Identification of severe deteriorationOther
Pharmacist identification of participant severe deterioration (i.e. suicide attempt)
Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribingOther
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 deprescribingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) | Experimental | 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 Receives: Other: Standard Pharmacist Care; Other: Reviewed Questionnaire tool results with participant; Other: Patient Clinical Assessment; Other: Psychotherapy Referral; Other: Pharmacist initiated interim telephone follow-up with participant; Other: Communication update with physician after participant contact; Other: Medication Counselling and Educational Support; Other: Non-medication Counselling; Other: Identification of drug interaction; Other: Identification of drug adverse effect; Other: Identification of severe deterioration; Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing; Other: Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing |
| Control Group (Standard Pharmacist Care) | Active comparator | 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 Receives: Other: Standard Pharmacist Care; Other: Medication Counselling and Educational Support; Other: Non-medication Counselling; Other: Identification of drug interaction; Other: Identification of drug adverse effect; Other: Identification of severe deterioration; Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score
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)
Measured: 6 months
Mean score difference in Generalized Anxiety Disorder 7-item (GAD-7) score
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)
Measured: 6 months
Secondary outcomes (5)
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
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)
Measured: 6 months
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
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)
Measured: 6 months
Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5
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)
Measured: 6 months
Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5
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)
Measured: 6 months
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.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start22 Mar 2023
- Primary completion31 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center randomized control trial evaluating the mean difference in depression and anxiety score with patients with major depressive disorder (MDD) and/or generalized anxiety disorder (GAD) by pharmacists with prescribing \& management interventions in comparison to pharmacist management per standard pharmacist care.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yazid Al Hamarneh, BSc (Pharm), PhD, CDM, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410575
- Sponsor's protocol ID
- REB ID Pro00093776
- Acronym
- MAP-AP
- Status last verified
- Jul 2025
- First submitted
- 21 May 2020
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Assessment and Prescribing by Alberta Pharmacists (MAP-AP)
- ClinicalTrials.gov ID
- NCT04410575
- Acronym / sponsor ID
- MAP-AP / REB ID Pro00093776
- Keywords
- Pharmacist, Prescribing, Major Depressive Disorder, Generalized Anxiety Disorder, Mental Health, Intervention, Expanded Scope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center randomized control trial evaluating the mean difference in depression and anxiety score with patients with major depressive disorder (MDD) and/or generalized anxiety disorder (GAD) by pharmacists with prescribing \& management interventions in comparison to pharmacist management per standard pharmacist care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) | Experimental | Other: Standard Pharmacist Care, Other: Reviewed Questionnaire tool results with participant, Other: Patient Clinical Assessment, Other: Psychotherapy Referral, Other: Pharmacist initiated interim telephone follow-up with participant, Other: Communication update with physician after participant contact, Other: Medication Counselling and Educational Support, Other: Non-medication Counselling, Other: Identification of drug interaction, Other: Identification of drug adverse effect, Other: Identification of severe deterioration, Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing, Other: Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribingParticipants 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 |
| Control Group (Standard Pharmacist Care) | Active comparator | Other: Standard Pharmacist Care, Other: Medication Counselling and Educational Support, Other: Non-medication Counselling, Other: Identification of drug interaction, Other: Identification of drug adverse effect, Other: Identification of severe deterioration, Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Pharmacist CareStandard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians) | Other | Control Group (Standard Pharmacist Care), Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Reviewed Questionnaire tool results with participantPharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment | Other | Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Patient Clinical AssessmentPharmacist 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 | Other | Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Psychotherapy ReferralPharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist | Other | Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Pharmacist initiated interim telephone follow-up with participantInterim 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) | Other | Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Communication update with physician after participant contactPharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant | Other | Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Medication Counselling and Educational SupportPharmacist provides medication related counselling and educational support to participant | Other | Control Group (Standard Pharmacist Care), Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Non-medication CounsellingPharmacist provides non-medication related counselling and educational support to participant | Other | Control Group (Standard Pharmacist Care), Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Identification of drug interactionPharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety | Other | Control Group (Standard Pharmacist Care), Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Identification of drug adverse effectPharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety | Other | Control Group (Standard Pharmacist Care), Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Identification of severe deteriorationPharmacist identification of participant severe deterioration (i.e. suicide attempt) | Other | Control Group (Standard Pharmacist Care), Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribingPharmacist 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 | Other | Control Group (Standard Pharmacist Care), Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
| Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribingPharmacist 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 | Other | Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) |
Primary outcome
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)
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)
5 secondary outcomes
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
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
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 Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yazid Al Hamarneh, BSc (Pharm), PhD, CDM principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Pharmacist Care, Reviewed Questionnaire tool results with participant and Patient Clinical Assessment in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.