Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1) (PAGE-1_AG1)
A Six-month Study of the Genecept Assay vs. Treatment as Usual to Evaluate Efficacy of Using Assay Guided Treatment in Outpatient Adults With Treatment Resistant Depression
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 depression (TRD) contributes disproportionately to the tremendous costs of MDD, in terms of health care costs, functional impairment, and diminished quality of life.
The promise of personalized medicine for individuals at high risk for TRD is apparent. If these individuals could be recognized early in their disease course, they could be triaged to more intensive or targeted interventions to improve their likelihood of remission. With the proliferation of treatment options in MDD, at present individuals can spend months or years in and out of treatment before receiving these next-step treatments.
At present, no clinical or biomarker-based tool has been shown to assist in matching patients with treatments most likely to be effective for them. The Genecept Assay offers the possibility of "Personalized Medicine" in psychiatry. Clinicians may find this additional genetic information can lead to optimized treatment plans for individual patients. Before such an assay can be widely applied clinically, it is necessary to demonstrate that this tool usefully impacts treatment outcomes.
This study will examine the potential impact of the assay in terms of depression severity at 3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate of its potential to change clinician behavior and improve patient quality of life. Further measures will also allow for refinement of the assay to maximize patient and clinician satisfaction, and estimate the potential savings associated with deployment of this assay in real-world clinical settings.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37228
- Centerstone
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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 Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Treatment as usual (TAU)
Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
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실험적: Genecept Assay
Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
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Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months
기간: 6 months
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To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months Add:
Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression |
6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.
기간: one week
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Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group).
Clinician choices will be compared.
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one week
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Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
기간: baseline, 3, 6 months
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To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.
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baseline, 3, 6 months
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Cost
기간: 6 months
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To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.
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6 months
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Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey
기간: 6 months
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To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder
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6 months
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Rachel Dicker, PharmD, Genomind, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Genecept Assay에 대한 임상 시험
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Seattle Institute for Biomedical and Clinical ResearchGenomind, LLC완전한
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Genomind, LLCMedpace, Inc.완전한
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Yonsei University완전한
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British Columbia Cancer AgencyCanadian Institutes of Health Research (CIHR)종료됨
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Grupo Español de Tratamiento de Tumores de Cabeza...모집하지 않고 적극적으로