Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 10
- 主要终点
- TSQM-9
研究概览
简要总结
This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches.
This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet the following criteria:
- •Recently started treatment (within 75 days of screening visit) with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features and having appropriate baseline measures collected before starting treatment. These patients are referred to as treatment-continuing subjects.
- •Scheduled to receive standard clinical treatment with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features. These patients are referred to as treatment-initiating subjects.
- •In addition, in order to be eligible, an individual must meet all of the following additional criteria:
- •Adult ages 18 or older
- •Provision of signed and dated informed consent form prior to any study procedures
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)
- •Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis
- •Active or recent (within 12 months) substance use disorder (other than nicotine)
研究组 & 干预措施
Spravato
Patients taking Spravato, an intranasal form of ketamine
干预措施: Spravato (Drug)
IV Ketamine
Patients taking IV ketamine
干预措施: IV Ketamine (Drug)
结局指标
主要结局
TSQM-9
时间窗: baseline to 6 months
9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Analyses will be done for the whole sample as well as for treatment-continuing patients who recently completed a randomized trial of ketamine v. esketamine (EQUIVALENCE). The primary analysis for this measure will analyze treatment-continuing patients. Scores range from 0 - 100 with higher scores indicating higher satisfaction.
次要结局
- Depression Severity (Self Report)(baseline to 6 months)
- Depression Severity (Clinician Report)(baseline to 6 months)
- Measure of Treatment Patterns: Number of treatments(baseline to 6 months)
- Measure of Treatment Patterns: Reasons for Discontinuation(baseline to 6 months)
- Measure of Treatment Patterns: Average Dose(baseline to 6 months)
- Measures of Adverse Events(Baseline to 6 months)