Depression - Major Depressive DisorderRITA-PCNCT06799078
Racial Disparities in Antidepressant Treatment After a Psychiatric Consultation
An observational study of Depression - Major Depressive Disorder and Depression Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Patients from black, indigenous, and people of color (BIPOC) communities are reported to have lower rates of antidepressant adherence and response. The investigators have a limited understanding of why this disparity exists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Disorders
- What is being tested?
- Observation while participants receive treatment by their primary care provider
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 4 Mar 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received an outpatient psychiatric consultation at CAMH within the past 3 months and received a diagnosis of depression, after which they were discharged to the care of their primary care provider
Who may be able to join
- Able and willing to sign and date the informed consent form
- Stated willingness to comply with all study procedures
- Age 18 years and older
- Diagnosis of depression in a psychiatric consultation at CAMH in the last 3 months
- Not currently followed by a psychiatrist
- Able to complete the REDCap questionnaire in English using the internet
Who cannot join
- Presence of a life-time diagnosis of bipolar disorder or schizophrenia
- Potential participants with a suicidal plan or intent whose consulting psychiatrist determined are in need of immediate clinical attention (e.g., referral to CAMH ED, voluntary or involuntary hospitalization)
- Acute psychosis (e.g., MDD with psychotic features)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Racial Disparities in Antidepressant Initiation, Titration, and Adherence After Receiving a Psychiatric Consultation
Patients from black, indigenous, and people of color (BIPOC) communities are reported to have lower rates of antidepressant adherence and response. The investigators have a limited understanding of why this disparity exists. The majority of outpatient psychiatric consultations are one-time assessments that provide treatment recommendations to the primary care provider. It is important to identify whether there are racial differences in accessing and adhering to recommended treatment plans to provide more equitable care. To the investigators' knowledge, there are no studies that examined racial differences in access and barriers to receiving antidepressant treatment after a one-time psychiatric assessment. This study focuses on patients who were diagnosed with major depressive disorder during a psychiatric consultation 3 months prior. We are examining whether there are racial differences in being a) recommended an antidepressant, b) started/switched to a recommended antidepressant, c) treated at a therapeutic dosage, d) adherence to treatment, and e) whether sociodemographic factors, discrimination in medical settings, and patient perception of depression and antidepressant treatment moderate these differences. This study will inform the development of treatment strategies that minimize racial disparities in the treatment of depression.
Read the detailed description
Overall Design:
The research design of this study combines two online questionnaires, a semi-structured qualitative interview (for a subset of participants), and a structured chart review. All participants who provide consent to participate in the study will be emailed the first online questionnaire a few days later and then the second online questionnaire three months after they have completed their consult. Twenty-four of these participants will also be invited to participate in the semi-structured qualitative interview in addition to the online questionnaires. The participants will have to complete the second online questionnaire prior to the qualitative interview. Chart review will be performed in all participants. Chart review will occur in parallel with the online questionnaires and the interview.
Participants will be recruited from the Centre for Addiction and Mental Health (CAMH) among patients: (1) diagnosed with depression during a one-time psychiatric consultation; (2) who either assent to be contacted regarding potential participation in research during their CAMH consultation, or who have indicated their agreement to be contacted regarding potential participation in research during the CAMH registration process. Potential participants will also be referred to the study by psychiatrists at CAMH after the patient completes a one-time outpatient psychiatric consultation if they assent to be contacted by the research team. Psychiatrists at CAMH will also be provided with REB-approved recruitment pamphlets to give to patients who express an interest in participating in the study, after which the patients can contact the research team directly if they are interested using the contact information provided in the pamphlet.
Shortly after the consultation is completed, potential participants will be contacted to confirm their interest in participation and to obtain informed consent. Shortly after, the participants will be emailed a link to complete a baseline 20-40 minute REDCap online questionnaire. The first online questionnaire will have two parts, the first part including questions about demographic information and the second part including clinical status and previously validated scales. Also, using a structured form adapted from another study conducted at CAMH, the participants' electronic health records will be reviewed to determine the content, structure, and length of the consultation note, the diagnoses given during the consultation, and treatment recommendations, including pharmacological (i.e., names and dosages of psychotropic medications) and non-pharmacological recommendations. Three months after they complete the psychiatric consultation, the participants will be emailed a link to complete the second 10- 20 minute REDCap online questionnaire, assessing treatment processes and outcomes.
In addition, a subgroup of 24 participants will be invited complete a semi-structured qualitative interview after they complete the second survey (using Webex). The participants will have to complete the second online questionnaire prior to the interview. All participants will be invited to take part in both the online questionnaires and the interview at the beginning of the study. This will continue until 12 participants who self-identify as BIPOC and 12 participants who self-identify as White have completed the interview.
Participant Recruitment and Screening:
The target is to have 50 - 100 participants completing the questionnaires, of which half will be participants who self-report as being from BIPOC communities. Invitation to participate in the interview will be offered to all participants from the beginning until 12 participants who self-identify as BIPOC and 12 participants who self-identify as White have completed it.
All potential participants will be contacted by phone by an investigator or a Research Analyst (RA) to screen for eligibility criteria and engage them in a consent discussion.
Sample Size Determination:
Assuming that there will be a 20 - 40% difference between participants who are from BIPOC communities and participants who are White in treatment outcomes (Kales et al., 2013; Simon et al., 2015), α = 0.05, power = 80%, sample size between 46 - 186 participants is sufficient to detect a between-group difference.
A systematic review of qualitative studies reported that the average sample size to reach saturation is 12-13 for homogeneous populations (Hennink \& Kaiser, 2022). As the study will consist of at least 2 distinct populations (participants who are White vs. from BIPOC communities), 12 participants from each group is sufficient.
Statistical Methods:
Between-group analyses will be performed by comparing White participants vs. participants from BIPOC communities. If there is a sufficient number of participants from a specific race/ethnicity to perform between-group analyses, secondary analyses will be performed by treating them as a separate group (e.g., White vs. Asian-South vs. Others).
Logistic regression analyses will be used to examine if there is an interaction effect between race/ ethnicity and potential moderators on observed racial disparities in treatment processes. Self-reported gender, annual income, any experience of discrimination in medical settings (DMS scale answer rarely or higher in any of the items), and having a negative perception of antidepressant treatment (Brief IPQ item 4 score < 5) will be explored as potential moderators.
Control of Bias:
Interviewer bias may occur during the semi-structured qualitative interview if the interviewer becomes aware of the participant's race/ ethnicity. To minimize this, interviewers will be unaware of the results of the REDCap questionnaires containing the race/ ethnicity information. Furthermore, interviewers will have a script they have to adhere to.
- Being tested
- Observation while participants receive treatment by their primary care provider
- Keywords
- antidepressant, consultation, depression, major depressive disorder, Race
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation while participants receive treatment by their primary care providerOther
Participants complete a consultation with a psychiatrist who makes some recommendations for the treatment of their depression. The participant's primary care provider decides whether to implement some of these recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Participants that self-identify as being BIPOC | Not described | |
| Participants that self-identify as being White | Not described Receives: Other: Observation while participants receive treatment by their primary care provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotropic medication initiation or change after psychiatric consultation
This information will be obtained during the first and second online surveys
Measured: From the psychiatric consultation to three months after the consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start4 Mar 2024
- Primary completion31 Aug 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Benoit Mulsant, Centre for Addiction and Mental Health
- Investigators
- Benoit H Mulsant, MD, MS, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799078
- Sponsor's protocol ID
- 2023-174
- Acronym
- RITA-PC
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will require additional consent from the study participants as well as REB approval.
Publications
Svarstad BL, Chewning BA, Sleath BL, Claesson C. The Brief Medication Questionnaire: a tool for screening patient adherence and barriers to adherence. Patient Educ Couns. 1999 Jun;37(2):113-24. doi: 10.1016/s0738-3991(98)00107-4.
PubMed 14528539Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Snowden LR, Thomas K. Medicaid and African American outpatient mental health treatment. Ment Health Serv Res. 2000 Jun;2(2):115-20. doi: 10.1023/a:1010161222515.
PubMed 11256718Simon GE, Coleman KJ, Waitzfelder BE, Beck A, Rossom RC, Stewart C, Penfold RB. Adjusting Antidepressant Quality Measures for Race and Ethnicity. JAMA Psychiatry. 2015 Oct;72(10):1055-6. doi: 10.1001/jamapsychiatry.2015.1437. No abstract available.
PubMed 26352783Rossom RC, Shortreed S, Coleman KJ, Beck A, Waitzfelder BE, Stewart C, Ahmedani BK, Zeber JE, Simon GE. ANTIDEPRESSANT ADHERENCE ACROSS DIVERSE POPULATIONS AND HEALTHCARE SETTINGS. Depress Anxiety. 2016 Aug;33(8):765-74. doi: 10.1002/da.22532. Epub 2016 Jun 20.
PubMed 27320786Peek ME, Nunez-Smith M, Drum M, Lewis TT. Adapting the everyday discrimination scale to medical settings: reliability and validity testing in a sample of African American patients. Ethn Dis. 2011 Autumn;21(4):502-9.
PubMed 22428358Paradies Y, Ben J, Denson N, Elias A, Priest N, Pieterse A, Gupta A, Kelaher M, Gee G. Racism as a Determinant of Health: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 23;10(9):e0138511. doi: 10.1371/journal.pone.0138511. eCollection 2015.
PubMed 26398658Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Kales HC, Nease DE Jr, Sirey JA, Zivin K, Kim HM, Kavanagh J, Lynn S, Chiang C, Neighbors HW, Valenstein M, Blow FC. Racial differences in adherence to antidepressant treatment in later life. Am J Geriatr Psychiatry. 2013 Oct;21(10):999-1009. doi: 10.1016/j.jagp.2013.01.046. Epub 2013 Feb 6.
PubMed 23602306Ishrat Husain M, Rodie DJ, Perivolaris A, Sanches M, Crawford A, Fitzgibbon KP, Levinson A, Geist R, Kurdyak P, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. A Collaborative-Care Telephone-Based Intervention for Depression, Anxiety, and at-Risk Drinking in Primary Care: The PARTNERs Randomized Clinical Trial. Can J Psychiatry. 2023 Oct;68(10):732-744. doi: 10.1177/07067437231156243. Epub 2023 Feb 28.
PubMed 36855791Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.
PubMed 34785096Fortuna LR, Alegria M, Gao S. Retention in depression treatment among ethnic and racial minority groups in the United States. Depress Anxiety. 2010 May;27(5):485-94. doi: 10.1002/da.20685.
PubMed 20336808Donneyong M, Reynolds C, Mischoulon D, Chang G, Luttmann-Gibson H, Bubes V, Guilds M, Manson J, Okereke O. Protocol for studying racial/ethnic disparities in depression care using joint information from participant surveys and administrative claims databases: an observational cohort study. BMJ Open. 2020 Jan 7;10(1):e033173. doi: 10.1136/bmjopen-2019-033173.
PubMed 31915172Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PubMed 16731240Breslau J, Cefalu M, Wong EC, Burnam MA, Hunter GP, Florez KR, Collins RL. Racial/ethnic differences in perception of need for mental health treatment in a US national sample. Soc Psychiatry Psychiatr Epidemiol. 2017 Aug;52(8):929-937. doi: 10.1007/s00127-017-1400-2. Epub 2017 May 26.
PubMed 28550518
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Disparities in Antidepressant Initiation, Titration, and Adherence After Receiving a Psychiatric Consultation
- ClinicalTrials.gov ID
- NCT06799078
- Acronym / sponsor ID
- RITA-PC / 2023-174
- Keywords
- antidepressant, consultation, depression, major depressive disorder, Race
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2025 (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.
Patients from black, indigenous, and people of color (BIPOC) communities are reported to have lower rates of antidepressant adherence and response. The investigators have a limited understanding of why this disparity exists. The majority of outpatient psychiatric consultations are one-time assessments that provide treatment recommendations to the primary care provider. It is important to identify whether there are racial differences in accessing and adhering to recommended treatment plans to provide more equitable care. To the investigators' knowledge, there are no studies that examined racial differences in access and barriers to receiving antidepressant treatment after a one-time psychiatric assessment. This study focuses on patients who were diagnosed with major depressive disorder during a psychiatric consultation 3 months prior. We are examining whether there are racial differences in being a) recommended an antidepressant, b) started/switched to a recommended antidepressant, c) treated at a therapeutic dosage, d) adherence to treatment, and e) whether sociodemographic factors, discrimination in medical settings, and patient perception of depression and antidepressant treatment moderate these differences. This study will inform the development of treatment strategies that minimize racial disparities in the treatment of depression.
Detailed description
Overall Design:
The research design of this study combines two online questionnaires, a semi-structured qualitative interview (for a subset of participants), and a structured chart review. All participants who provide consent to participate in the study will be emailed the first online questionnaire a few days later and then the second online questionnaire three months after they have completed their consult. Twenty-four of these participants will also be invited to participate in the semi-structured qualitative interview in addition to the online questionnaires. The participants will have to complete the second online questionnaire prior to the qualitative interview. Chart review will be performed in all participants. Chart review will occur in parallel with the online questionnaires and the interview.
Participants will be recruited from the Centre for Addiction and Mental Health (CAMH) among patients: (1) diagnosed with depression during a one-time psychiatric consultation; (2) who either assent to be contacted regarding potential participation in research during their CAMH consultation, or who have indicated their agreement to be contacted regarding potential participation in research during the CAMH registration process. Potential participants will also be referred to the study by psychiatrists at CAMH after the patient completes a one-time outpatient psychiatric consultation if they assent to be contacted by the research team. Psychiatrists at CAMH will also be provided with REB-approved recruitment pamphlets to give to patients who express an interest in participating in the study, after which the patients can contact the research team directly if they are interested using the contact information provided in the pamphlet.
Shortly after the consultation is completed, potential participants will be contacted to confirm their interest in participation and to obtain informed consent. Shortly after, the participants will be emailed a link to complete a baseline 20-40 minute REDCap online questionnaire. The first online questionnaire will have two parts, the first part including questions about demographic information and the second part including clinical status and previously validated scales. Also, using a structured form adapted from another study conducted at CAMH, the participants' electronic health records will be reviewed to determine the content, structure, and length of the consultation note, the diagnoses given during the consultation, and treatment recommendations, including pharmacological (i.e., names and dosages of psychotropic medications) and non-pharmacological recommendations. Three months after they complete the psychiatric consultation, the participants will be emailed a link to complete the second 10- 20 minute REDCap online questionnaire, assessing treatment processes and outcomes.
In addition, a subgroup of 24 participants will be invited complete a semi-structured qualitative interview after they complete the second survey (using Webex). The participants will have to complete the second online questionnaire prior to the interview. All participants will be invited to take part in both the online questionnaires and the interview at the beginning of the study. This will continue until 12 participants who self-identify as BIPOC and 12 participants who self-identify as White have completed the interview.
Participant Recruitment and Screening:
The target is to have 50 - 100 participants completing the questionnaires, of which half will be participants who self-report as being from BIPOC communities. Invitation to participate in the interview will be offered to all participants from the beginning until 12 participants who self-identify as BIPOC and 12 participants who self-identify as White have completed it.
All potential participants will be contacted by phone by an investigator or a Research Analyst (RA) to screen for eligibility criteria and engage them in a consent discussion.
Sample Size Determination:
Assuming that there will be a 20 - 40% difference between participants who are from BIPOC communities and participants who are White in treatment outcomes (Kales et al., 2013; Simon et al., 2015), α = 0.05, power = 80%, sample size between 46 - 186 participants is sufficient to detect a between-group difference.
A systematic review of qualitative studies reported that the average sample size to reach saturation is 12-13 for homogeneous populations (Hennink \& Kaiser, 2022). As the study will consist of at least 2 distinct populations (participants who are White vs. from BIPOC communities), 12 participants from each group is sufficient.
Statistical Methods:
Between-group analyses will be performed by comparing White participants vs. participants from BIPOC communities. If there is a sufficient number of participants from a specific race/ethnicity to perform between-group analyses, secondary analyses will be performed by treating them as a separate group (e.g., White vs. Asian-South vs. Others).
Logistic regression analyses will be used to examine if there is an interaction effect between race/ ethnicity and potential moderators on observed racial disparities in treatment processes. Self-reported gender, annual income, any experience of discrimination in medical settings (DMS scale answer rarely or higher in any of the items), and having a negative perception of antidepressant treatment (Brief IPQ item 4 score < 5) will be explored as potential moderators.
Control of Bias:
Interviewer bias may occur during the semi-structured qualitative interview if the interviewer becomes aware of the participant's race/ ethnicity. To minimize this, interviewers will be unaware of the results of the REDCap questionnaires containing the race/ ethnicity information. Furthermore, interviewers will have a script they have to adhere to.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants that self-identify as being BIPOC | – | – |
| Participants that self-identify as being White | – | Other: Observation while participants receive treatment by their primary care provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received an outpatient psychiatric consultation at CAMH within the past 3 months and received a diagnosis of depression, after which they were discharged to the care of their primary care provider
Key inclusion criteria (6 listed)
- Able and willing to sign and date the informed consent form
- Stated willingness to comply with all study procedures
- Age 18 years and older
- Diagnosis of depression in a psychiatric consultation at CAMH in the last 3 months
- Not currently followed by a psychiatrist
Key exclusion criteria (3 listed)
- Presence of a life-time diagnosis of bipolar disorder or schizophrenia
- Potential participants with a suicidal plan or intent whose consulting psychiatrist determined are in need of immediate clinical attention (e.g., referral to CAMH ED, voluntary or involuntary hospitalization)
- Acute psychosis (e.g., MDD with psychotic features)
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 |
|---|---|---|
| Observation while participants receive treatment by their primary care providerParticipants complete a consultation with a psychiatrist who makes some recommendations for the treatment of their depression. The participant's primary care provider decides whether to implement some of these recommendations. | Other | Participants that self-identify as being White |
Primary outcome
Psychotropic medication initiation or change after psychiatric consultation
Time frame: From the psychiatric consultation to three months after the consultation
This information will be obtained during the first and second online surveys
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 14528539Svarstad BL, Chewning BA, Sleath BL, Claesson C. The Brief Medication Questionnaire: a tool for screening patient adherence and barriers to adherence. Patient Educ Couns. 1999 Jun;37(2):113-24. doi: 10.1016/s0738-3991(98)00107-4.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 11256718Snowden LR, Thomas K. Medicaid and African American outpatient mental health treatment. Ment Health Serv Res. 2000 Jun;2(2):115-20. doi: 10.1023/a:1010161222515.
- Background: PubMed 26352783Simon GE, Coleman KJ, Waitzfelder BE, Beck A, Rossom RC, Stewart C, Penfold RB. Adjusting Antidepressant Quality Measures for Race and Ethnicity. JAMA Psychiatry. 2015 Oct;72(10):1055-6. doi: 10.1001/jamapsychiatry.2015.1437. No abstract available.
- Background: PubMed 27320786Rossom RC, Shortreed S, Coleman KJ, Beck A, Waitzfelder BE, Stewart C, Ahmedani BK, Zeber JE, Simon GE. ANTIDEPRESSANT ADHERENCE ACROSS DIVERSE POPULATIONS AND HEALTHCARE SETTINGS. Depress Anxiety. 2016 Aug;33(8):765-74. doi: 10.1002/da.22532. Epub 2016 Jun 20.
- Background: PubMed 22428358Peek ME, Nunez-Smith M, Drum M, Lewis TT. Adapting the everyday discrimination scale to medical settings: reliability and validity testing in a sample of African American patients. Ethn Dis. 2011 Autumn;21(4):502-9.
- Background: PubMed 26398658Paradies Y, Ben J, Denson N, Elias A, Priest N, Pieterse A, Gupta A, Kelaher M, Gee G. Racism as a Determinant of Health: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 23;10(9):e0138511. doi: 10.1371/journal.pone.0138511. eCollection 2015.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 23602306Kales HC, Nease DE Jr, Sirey JA, Zivin K, Kim HM, Kavanagh J, Lynn S, Chiang C, Neighbors HW, Valenstein M, Blow FC. Racial differences in adherence to antidepressant treatment in later life. Am J Geriatr Psychiatry. 2013 Oct;21(10):999-1009. doi: 10.1016/j.jagp.2013.01.046. Epub 2013 Feb 6.
- Background: PubMed 36855791Ishrat Husain M, Rodie DJ, Perivolaris A, Sanches M, Crawford A, Fitzgibbon KP, Levinson A, Geist R, Kurdyak P, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. A Collaborative-Care Telephone-Based Intervention for Depression, Anxiety, and at-Risk Drinking in Primary Care: The PARTNERs Randomized Clinical Trial. Can J Psychiatry. 2023 Oct;68(10):732-744. doi: 10.1177/07067437231156243. Epub 2023 Feb 28.
- Background: PubMed 34785096Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.
- Background: PubMed 20336808Fortuna LR, Alegria M, Gao S. Retention in depression treatment among ethnic and racial minority groups in the United States. Depress Anxiety. 2010 May;27(5):485-94. doi: 10.1002/da.20685.
- Hayes, A. F. (2022). Introduction to Mediation, Moderation, and Conditional Process Analysis. A Regression-Based Approach (Tgurd ed.). New York: Guilford PressLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This will require additional consent from the study participants as well as REB approval.
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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.
Benoit H Mulsant, MD, MS principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Depression Disorders, run by Centre for Addiction and Mental Health 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Psychotropic medication initiation or change after psychiatric consultation (time frame: From the psychiatric consultation to three months after the consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06799078, which also lists 15 linked publications.
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 13 Apr 2026.