Pharmacogenomic Testing to Optimize Antidepressant Drug Therapy

NCT03591224 | Completed

• 1 other identifier: Pro00025062
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 2

Brief Summary

A randomized controlled trial comparing pharmacogenomic guided versus standard pharmacist care to optimize antidepressant drug therapy. This study evaluates the effectiveness of pharmacists utilizing pharmacogenomic testing in the community pharmacy setting to help patients find the most appropriate drug therapy option(s) and minimize the risk of side effects in collaboration with prescribing physicians.

Conditions

Depression; Anxiety; Major Depressive Disorder; Generalized Anxiety Disorder; Mood Disorders

Keywords

pharmacogenetics; pharmacogenomics; antidepressants; pharmacy; pharmacist; community

Outcome Measures

Primary Outcomes (4)

• Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) - general measure of satisfaction to drug therapy

  This scale evaluates patient satisfaction of drug treatment for with any chronic disease. It's a brief, self-administer multidimensional generic questionnaire comprising 17 items. There are six categories of questions assessing satisfaction of (1) drug efficacy, (2) side-effects, (3) convenience of use, (4) medical care, (5) impact on activities of daily living and (6) general satisfaction. Scores of individual items range from 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A higher total score is an indication of greater satisfaction with drug therapy. Only scores from the side effects category would be summed as negative values. There is no recommended cutoff score, however is used to monitor the overall satisfaction to treatment over the period of the study.

  Change of score from baseline to 6 months

• Patient Health Questionnaire (PHQ-9) - measure/monitor the severity of depression

  PHQ-9 is a clinical evidence-based scale used to assess the severity of depression. There are nine diagnostic criteria for major depression based on the Diagnostic and Statistical 4th Ed. (DSM-IV) which are scored '0' (not at all), '1' (several days),'2' more than half the days, '3' (nearly every day). The nine items cover experience of pleasure, feeling down, sleep disruption, energy levels, appetite, feeling a failure, trouble concentrating, speaking slowly or being fidgety and having negative thoughts around suicide or self-harm over the previous 2 weeks. The total sum indicates depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

  Change of score from baseline to 6 months

• Generalized Anxiety Disorder-7 (GAD-7) - measure/monitor the severity of anxiety

  Evidence-based questionnaire used to monitor the severity of generalized anxiety. The GAD-7 score is calculated by assigning scores of '0' (not at all), '1' (several days),'2' more than half the days, '3' (nearly every day). Questions assess the tendency of feeling nervous, not being able to stop or control worrying, worrying too much about different things, trouble relaxing, being so restless that it's hard to sit still, becoming easily annoyed or irritable, feeling afraid as if something awful might happen. Total sums of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively.

  Change of score from baseline to 6 months

• Sheehan Disability Scale - measure of functional impairment in work/school, social life, and family life

  This scale assesses functional impairment using three 0 to 10 point visual analog scales. This can also be interpreted as percentages. Each of the three scales would have the patient represent how have their symptoms disrupted (1) work/school life, (2) social life, and (3) family life/responsibilities. The points from the 3 scales are summed as a global functional impairment score ranging from 0 (unimpaired) to 30 (highly impaired). There is no recommended cutoff score, however is used to monitor the response to treatment over the period of the study. In general, a score of 5 or greater on any of the three scales is associated with significant functional impairment.

  Change of score from baseline to 6 months

Secondary Outcomes (2)

• Number of pharmacist identified drug therapy problems

  Analysis done at the completion of study (~1 year)

• Prescriber acceptance rate of pharmacist's recommendations

  Analysis done at the completion of study (~1 year)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Pharmacist optimizing antidepressant therapy using the patient's personalized pharmacogenomic report to make recommendations.

Other: Pharmacogenomic Testing

Control

PLACEBO COMPARATOR

Pharmacist optimizing antidepressant therapy based on standard of care

Other: Pharmacist Standard of Care

Interventions

Pharmacogenomic Testing OTHER

pharmacogenomic drug response test provides personalized insights on a patient's predicted response to medications based on metabolism

Also known as: Pillcheck, Geneyouin

Intervention

Pharmacist Standard of Care OTHER

Pharmacist providing standard of care as per usual practice

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prescribed one or more antidepressants
• Diagnosed with major depressive disorder and/or generalized anxiety disorder
• Newly initiated on antidepressant therapy or a recent change in therapy and dissatisfied with therapy.
• Experiencing adverse drug reaction(s) or suboptimal response or dissatisfaction with therapy
• Demonstrated dissatisfaction based on a 9-item prescreening questionnaire. Scoring range from 0='not at all' to 4='very much'. If any scores for Q1-3 on side effects \>2, or if any scores for Q4-6 on effectiveness \<2, or if any scores for Q7-9 on overall opinion of therapy \<2.
• \[Q1. Side effects interfere with my physical activity, Q2. Side effects interfere with my leisure activities, Q3. Side effects interfere with my daily activities, Q4. The medicine I am taking reduces my symptoms, Q5. I am satisfied with the time it takes for the medicine to start to have an effect, Q6. I feel better now than I did before starting the treatment, Q7.I intend to continue using this treatment, Q8. I feel happy with my treatment, Q9. In general, I feel satisfied with the treatment.\]

You may not qualify if:

• Patients with poor command of English or who are unable to provide fully informed consent
• Liver transplant patient (cheek swab won't detect liver DNA)
• Non-adherent to prescribed drug therapy due to reasons outside of "not feeling better" (non-medical influencing factors)
• Diagnosis of schizophrenia, bipolar disorder, dementia
• Patients under 18 years old

Sponsors & Collaborators

• John Papastergiou Pharmacy Ltd: lead
• Green Shield Canada: collaborator

Study Sites (2)

John Papastergiou Pharmacy Ltd - Store#500

Toronto, Ontario, M4C 1H6, Canada

Location

John Papastergiou Pharmacy Ltd - Store#994

Toronto, Ontario, M4J 1L2, Canada

Location

Related Publications (2)

• Rejas J, Ruiz MA, Pardo A, Soto J. Minimally important difference of the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). BMC Med Res Methodol. 2011 Oct 20;11:142. doi: 10.1186/1471-2288-11-142.

  PMID: 22014277 BACKGROUND

• Papastergiou J, Quilty LC, Li W, Thiruchselvam T, Jain E, Gove P, Mandlsohn L, van den Bemt B, Pojskic N. Pharmacogenomics guided versus standard antidepressant treatment in a community pharmacy setting: A randomized controlled trial. Clin Transl Sci. 2021 Jul;14(4):1359-1368. doi: 10.1111/cts.12986. Epub 2021 Feb 28.

  PMID: 33641259 DERIVED

Related Links

• Company providing pharmacogenetic testing to optimize drug therapy
• Sheehan Disability Scale
• PHQ-9 Questionnaire

MeSH Terms

Conditions

Depression; Anxiety Disorders; Depressive Disorder, Major; Generalized Anxiety Disorder; Mood Disorders

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• John Papastergiou, B.Sc.Phm

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Wilson Li, B.Sc.Phm

  John Papastergiou Pharmacy Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients are not told of their group assignment until the end of the study, at which point they would receive a copy of their pharmacogenetic report. The consulting pharmacist also does not have knowledge of the patient's group assignment in the first encounter for baseline data collection. Group assignment is only revealed to the pharmacist after two weeks when the pharmacogenetic report is available on the Pillcheck online portal. Patients assigned to the control group will have their report appear blank to the pharmacist, whereas the intervention patient group will have their full pharmacogenetic report accessible by the consulting pharmacist. Prescribers are also informed via fax briefly of the study protocol and asked to maintain blinding of their patient's group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Enrolled subjects will be randomly assigned to either the control arm (pharmacist standard of care) or intervention arm (pharmacogenetic guided decision making by the pharmacist) in optimizing antidepressant drug therapy. Randomization is done by the primary investigator who isn't directly involved with patient consultations.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 19, 2018
• Study Start: April 17, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CA (2)