Depression Clinical Trial
Official title:
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
Many patients with depression do not respond well to medication and are diagnosed with treatment refractory depression (TRD). Sometimes medications don't work because an individual metabolizes the drugs in an atypical manner (too fast/slow). Alternatively, drugs may fail to work because the underlying sub-type of depression is not effectively targeted by a medication. This study will use genetic testing of subjects with TRD to personalize the drug treatment of depression and guide the patient to a better clinical outcome. In the guided group, the clinician will receive a pharmacogenetic report to help individually tailor medication selection for TRD patients, potentially allowing the clinician to pick more effective medications right away, and when necessary, use drug combinations that are well-tolerated and less likely to cause unwanted side effects. The control group will receive a sham genetic report and be treated according to typical standards of care. The investigators will conduct our study in a "real world" setting, with few restrictions on which TRD patients can participate. In this way, the findings may be more likely to reveal how useful genetic testing will be when applied more broadly in psychiatry.
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.
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