- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04469322
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design and Methods. The investigators will use prospective methods to assess the utility of pharmacogenetic guided treatment (PGT) of TRD. The use of genetic testing for PGT subjects, and clinical care guided by the individual's genetic results are the only subject activities in this study that represent a departure from standard clinical care. Other activities carried out within the context of this study are conducted in accordance with accepted clinical practice by a trained and licensed psychiatrist. These include (but are not limited to) the use of prescription medications, laboratory testing, vital sign measurements, mood scales and diagnostic interviews, electrocardiograms, and imaging studies. Standard clinical activities will be conducted at the discretion of the attending psychiatrist, determined by the clinical needs of the individual patient. All laboratory testing conducted for the purposes of clinical treatment (diagnosis, treatment, and prevention of illness) will be conducted at the VA San Diego or VA Palo Alto accredited clinical laboratories. No investigational medications or devices will be used in this study.
Setting: Clinical care will be conducted at the Veterans Affairs San Diego Healthcare System and Veterans Affairs Palo Alto Healthcare . Patients with TRD will be recruited from multiple sites in the local VA Systems. Clinical care will be provided by a VA psychiatrist.
Genotyping: After obtaining written consent, patients will give a saliva sample from which genomic DNA is prepared using established protocols. DNA samples will be assigned a coded subject identification number that will not contain any sensitive personal information. The code key will remain at the VASDHS at all times. Samples will be sent to a CLIA certified laboratory (Pathway Genomics) for genotyping and analyzed using the commercially available Mental Health DNA Insight Test. Unused DNA sent for genotyping will be destroyed. No DNA storage outside the VASDHS will be permitted. No other clinically relevant information will be uncovered by the genetic testing.
Randomization & Study Design: Patients will be randomly assigned to one of two groups: Pharmacogenetic guided treatment (PGT) and treatment as usual (TAU). All patients will provide a saliva sample at the start of their participation 5-7 days before their initial clinic appointment: All subjects will be genotyped and analyzed using the Mental Health DNA Insight Test. The treating physician for the PGT group will receive the report before the first clinic visit. The treating physician for the TAU group will receive a sham report.
Patients will remain blind into which treatment group they are assigned until completion of the study. The study physicians will not be blinded due to the need to review the PGT report. However, bias will be reduced by using patient self-reports of their mood using the 16-item quick inventory of depressive symptoms self report (QIDS-SR16) scale. All patients will then be seen by a study psychiatrist at 4 weeks and 8 weeks follow-up. All patients will complete self assessment inventories at each visit. In addition they will assess tolerability using a standardized side effect checklist. Overall functional impairment and symptom severity will be assessed using the Clinical Global Impressions Scale (CGI). Primary study outcome will be the CGI score at the end of the study (8 weeks). A Comprehensive Suicide Risk Assessment will be done at study initiation and a clinical suicidality assessment will be conducted at every visit according to usual clinical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92161
- VA San Diego Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >18
- Veteran
- Psychiatric diagnosis
- Clinically significant depressive symptoms
- Failed 1 or more adequate treatment trials
Exclusion Criteria:
- No clinically significant symptoms of depression
- No previous medication trials
- Pregnancy
- Inpatient medical or psychiatric hospitalization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pharmacogenetic Test Guided
Treating physician for this group receives a detailed pharmacogenetic report for the patient, prioritizing 53 psychoactive medications into 4 use categories: preferential use, use as directed, may have significant limitations, and may have severe adverse reactions.
|
Pharmacogenetic report based on the patients DNA profile at ~45 SNP markers covering 16 genes
|
SHAM_COMPARATOR: Treatment As Usual
Treating physician receives a sham report listing the names of all drugs and treats patients according to standard of care.
|
Names of 53 medications listed with "use as directed"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression (CGI)
Time Frame: 8 weeks
|
Observer rated 7 item scale indicating overall clinical severity of depression (1 asymptomatic - 7 severe)
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression (CGI)
Time Frame: 0 weeks
|
Observer rated 7 item scale indicating overall clinical severity of depression (1 asymptomatic - 7 severe)
|
0 weeks
|
Clinical Global Impression (CGI)
Time Frame: 4 weeks
|
Observer rated 7 item scale indicating overall clinical severity of depression (1 asymptomatic - 7 severe)
|
4 weeks
|
Side Effects Burden
Time Frame: 0 weeks
|
Total of Side Effects Using Standardized Scale (scored 0 asymptomatic - 37 severe)
|
0 weeks
|
Side Effects Burden
Time Frame: 4 weeks
|
Total of Side Effects Using Standardized Scale (scored 0 asymptomatic - 37 severe)
|
4 weeks
|
Side Effects Burden
Time Frame: 8 weeks
|
Total of Side Effects Using Standardized Scale (scored 0 asymptomatic - 37 severe)
|
8 weeks
|
Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16)
Time Frame: 0 weeks
|
Self Reported Depression Symptoms (scored 1 mild - 27 severe)
|
0 weeks
|
Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16)
Time Frame: 4 weeks
|
Self Reported Depression Symptoms (scored 1 mild - 27 severe)
|
4 weeks
|
Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16)
Time Frame: 8 weeks
|
Self Reported Depression Symptoms (scored 1 mild - 27 severe)
|
8 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H130471
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depressive Disorder
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Samsung Medical CenterUnknownMajor Depressive Disorder, Anxiety DisorderKorea, Republic of
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedDepressive Disorder, Major Depressive DisorderUnited States
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
Clinical Trials on Mental Health DNA Insight Test (Pathway Genomics)
-
San Diego Veterans Healthcare SystemPathway Genomics CorpUnknown
-
University of California, San DiegoCompleted
-
Washington University School of MedicineUnknownMental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)United States
-
Washington University School of MedicineCompletedDementia | Frontotemporal Dementia | Dementia Alzheimers | Pick's Disease With DementiaUnited States
-
Defense and Veterans Center for Integrative Pain...Henry M. Jackson Foundation for the Advancement of Military MedicineTerminated
-
Wageningen UniversityActive, not recruitingCardiovascular Diseases | Mortality | Type 2 Diabetes Mellitus | Cognitive Decline | Mental Well-being | Kidney FunctionNetherlands
-
University of OxfordRecruitingCoronavirus Infection | Multi-Organ DisorderUnited Kingdom
-
Freeman-Sheldon Research Group, Inc.WithdrawnCraniofacial Abnormalities | ArthrogryposisUnited States
-
Taipei Veterans General Hospital, TaiwanNot yet recruitingInflammation | Sjogren's Syndrome | Dry Eye Syndrome | Healthy ControlTaiwan
-
Freeman-Sheldon Research Group, Inc.TerminatedDepressive Disorder | Craniofacial Abnormalities | Posttraumatic Stress Disorder | ArthrogryposisUnited States, Guatemala