Status:
TERMINATED
Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1)
Lead Sponsor:
Genomind, LLC
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
One-third or more of individuals treated for major depressive disorder (MDD) do not experience remission of symptoms despite at least two adequate antidepressant trials. Such treatment-resistant depre...
Eligibility Criteria
Inclusion
- age 18-65
- written informed consent
- diagnosis of non-psychotic major depression as determined by study
- clinician/current medical prescriber, and mood disorder diagnosis confirmed by PHQ-9
- QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit
- failure of at least 1 prior adequate trial of a standard antidepressant (by ATRQ criteria - i.e., 6 weeks at adequate dose)
Exclusion
- psychotic features in the current episode, based upon clinical assessment
- 4 or more failed pharmacologic interventions in the current major depressive episode \[response rates for these subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects\]
- current substance use disorder other than nicotine which based upon clinical assessment requires inpatient or outpatient detoxification
- pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
- women who are breastfeeding
- serious suicide or homicide risk, as assessed by evaluating clinician
- other unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests
- patients who have taken an investigational psychotropic drug within the last 3 months
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01426516
Start Date
September 1 2011
End Date
June 1 2014
Last Update
September 13 2021
Active Locations (1)
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1
Centerstone
Nashville, Tennessee, United States, 37228