VA Aripiprazole vs. Esketamine for Treatment of Depression VAST-D II
VA 阿立哌唑与艾氯胺酮治疗抑郁症 VAST-D II
基本信息
- 批准号:10426080
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-10-01 至 2026-09-30
- 项目状态:未结题
- 来源:
- 关键词:AcuteAdherenceAdultAdverse effectsAlgorithmsAntidepressive AgentsBenefits and RisksBlindedBupropionCaringChronicChronically IllDataDecision MakingDepressed moodDiseaseDisease remissionDissociationDoseDrug CostsEffectivenessEquipment and supply inventoriesFeeling suicidalGoalsHealthHourIntentionKnowledgeMajor Depressive DisorderMeasuresMedicalMental DepressionMental HealthMental Health ServicesMental disordersMetabolicMethodologyMonitorMulticenter StudiesNeurocognitiveOralOutcomeParticipantPatientsPharmaceutical PreparationsPhasePlacebo ControlPlacebosPost-Traumatic Stress DisordersPractice GuidelinesProtocols documentationPublic HealthQuality of lifeRandomizedRandomized, Controlled TrialsResearchResourcesRiskRoleSafetySedation procedureSeriesSeveritiesSiteSubstance abuse problemSubstance-Related DisordersSuicideTestingTimeTranslatingUnited States Food and Drug AdministrationVeteransVeterans Health Administrationactive comparatoraddictionaripiprazoleatypical antipsychoticburden of illnessclinical implementationcomparativecomparative effectivenesscooperative studycostcost effective treatmentcost effectivenessdepressed patientdepressive symptomsdisabilitydiscontinuation studyefficacy evaluationfollow-uphealth care settingshigh riskimprovedindexinginterestinventory of depressive symptomatologymeetingsnovel therapeuticsopen labelparticipant enrollmentphase 3 studypragmatic trialprimary outcomeprogramsrandomized, clinical trialsreduce symptomsrelapse preventionrisk mitigationsecondary analysissecondary outcomeside effectsuicidalsuicidal behaviorsuicidal risksymposiumtooltreatment comparisontreatment strategytreatment trialtreatment-resistant depressiontrial comparing
项目摘要
Project Summary/Abstract
Among all medical, mental health and substance related disorders, Major Depressive Disorder (MDD) is the
leading cause disease burden worldwide; MDD is a major cause of suffering and disability for those receiving
their care from the Veterans Health Administration (VHA). Current treatments have limited effectiveness as
only about 30% of patients achieve remission with the first antidepressant treatment. By regulatory convention,
the term treatment-resistant depression (TRD) is used when a depressed patient has not responded to two or
more adequate treatment trials in the current episode. So defined, patients with TRD account for a
disproportionately large share of treatment resources and, despite such efforts, are at the highest risk to
become chronically ill, develop a complicating substance abuse disorder and/or die by suicide. The CSP 576,
VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D), showed that
adjunctive aripiprazole resulted in a significantly greater likelihood of remission as compared to switching to
bupropion. Secondary analyses of VAST-D demonstrated that the advantage of adjunctive aripiprazole among
12-week remitters was sustained across up to six months of therapy and was evident whether or not patients
had co-occurring PTSD. In 2019 the U.S. Food and Drug Administration (FDA) reviewed intranasal esketamine
as a new therapy for treatment of TRD. The safety and efficacy of esketamine was evaluated in a series of
phase III studies that ultimately led to the FDA approval of esketamine (Spravato) for the treatment of TRD in
adults. The proposed study will be an open-label, parallel-group, randomized clinical trial of up to 6 months
treatment of adjunctive intranasal esketamine vs. adjunctive aripiprazole in Veterans with TRD. This study will
assess the efficacy, safety, and acceptability of adjunctive intranasal esketamine in direct comparison to
adjunctive aripiprazole for therapy of TRD. The primary hypothesis is that participants receiving adjunctive
intranasal esketamine will be significantly more likely to achieve remission after six weeks of treatment as
compared to those who receive adjunctive aripiprazole. Depressive symptoms will be assessed by
independent evaluators without knowledge of treatment assignment using the Quick Inventory of Depressive
Symptomatology clinician rating (QIDS-C), which is a well-validated tool that commonly and is easily translated
across other depression inventory scales. The study is powered to be able to detect an absolute difference in
remission rates of 10% or larger at 6 weeks. Secondary outcomes of interest include symptom reduction
across 6 months of randomized therapy, side effects and other tolerability indices, suicidality, and measures of
quality of life and cost-effectiveness.
项目总结/文摘
项目成果
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