NCT06138691已完成1 期
Medication-assisted Psychotherapy: Using Ketamine-enhanced Radically Open Dialectical Behavior Therapy (RO DBT) to Target Neural and Behavioral Mechanisms of Action in Adults With Moderate to Severe Depression
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Remission from Depression
研究概览
简要总结
This pilot study will assess the safety and feasibility of intravenous (IV) ketamine combined with RO DBT in young adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine with this type of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-65
- •Moderate to severe persistent depression [treatment resistant depression - TRD] (exhibiting 2+ unipolar major depression episodes (non-delusional) with prior treatment non-response to antidepressant or psychosocial treatment
- •Treatment-resistant depression: defined as unipolar major depressive disorder, non-delusional (diagnosed by SCID-5, Structured Clinical Interview for the DSM ) that persists despite ≥ 2 adequate antidepressant trials of different classes in the current episode; including at least one evidence-based second-line treatment in the current episode (including serotonin norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion, lithium, or Triiodothyroinine) higher proportion of OC (over controlled) words endorsed compared to UC (Under controlled) words on the Word Pairs Checklist
- •no current or past psychosis
- •English speaking
- •Able to attend in-person behavioral sessions and ketamine/therapy visits
- •Willingness to have RO DBT-A as only psychosocial treatment engaged in (medication treatment may continue-but see below for exclusion)
排除标准
- •Outside age range
- •Significant neurological condition (i.e., seizure, stroke, severe head injury) or mental retardation (IQ<70)
- •Current or recent substance use disorder, actively suicidal or homicidal (e.g., requires hospitalization)
- •Use of naltrexone, memantine or medication considered contraindicated with ketamine
- •Baseline systolic BP > 150 systolic or 90 diastolic at evaluation. Participants who initially present with elevated blood pressure may be re-assessed; and if needed, referred to their healthcare provider for hypertension management
- •Taking more than 2 adequately-dosed oral antidepressants
- •Inability to understand, speak and read English sufficiently
- •Not be pregnant or at risk of becoming pregnant
- •Medical conditions or medication usage that in the judgement of the investigators puts the patient at unreasonable safety risk
- •First degree relative with a psychotic diagnosis involving hallucinations, delusions, or disorganized thinking and speech (e.g. schizophrenia, schizoaffective disorder, etc)
结局指标
主要结局
Remission from Depression
时间窗: Approximately 5 months
Remission defined as Montgomery and Asberg Depression Rating Scale (MADRS) score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.
次要结局
- SCS-R and UCLA Loneliness Scale(Approximately 5 months)
- Visual analogue scale of depressive and anxiety symptoms(Daily following ketamine and therapy sessions during 4 weeks of ketamine-assisted RO DBT)
- RewP(Approximately 5 months)
- ERN(Approximately 5 months)
研究者
研究点 (2)
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