The Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms) Case Series. Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Depressive symptoms
研究概览
简要总结
The goal of this open label case series is to learn about the feasibility of conducting a future randomised controlled trial to evaluate how well the Perinatal SMILES intervention works in improving post-cesarean mood in low-income women.
The main questions it aims to answer are:
- Is it feasible to recruit a sufficient number of participants?
- Is it feasible to administer Perinatal SMILES and
- Is it feasible to collect participant outcomes?
To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine
Participants will:
- Complete five sessions of interpersonal therapy
- Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day
- Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection
- Undergo assessments of brain electrical activity (at rest and evoked by trans-cranial magnetic stimulation) before and at three timepoints in the 10 hours after each ketamine injection
- Complete mood assessments over the first 12 postpartum weeks
详细描述
The investigators will perform an open-label case series to evaluate the feasibility of performing a trial of a novel intervention to reduce postpartum depression symptoms after cesarean delivery. The intervention, Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms), combines interpersonal therapy with subcutaneous ketamine therapy. The interpersonal therapy consists of five sessions that will be administered during the antepartum and/or postpartum. The ketamine therapy will be administered as two injections, approximately 24 hours apart, in the first four postpartum days and will be preceded and followed by additional therapy sessions. The investigators will assess brain electronic activity before and after the ketamine injections and mood in the first 12 postpartum weeks. The objective is to determine the feasibility of recruiting participant, administering the intervention and collect the outcome data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention Interpersonal psychotherapy plus ketamine
Five sessions of interpersonal psychotherapy (IPT) and pre-, and post-, ketamine sessions b) Two doses of subcutaneous (SC) ketamine in the first 4 post-cesarean days
干预措施: Ketamine (Drug)
Intervention Interpersonal psychotherapy plus ketamine
Five sessions of interpersonal psychotherapy (IPT) and pre-, and post-, ketamine sessions b) Two doses of subcutaneous (SC) ketamine in the first 4 post-cesarean days
干预措施: interpersonal psychotherapy (IPT) (Behavioral)
结局指标
主要结局
Depressive symptoms
时间窗: through postoperative day 84
These will be assessed using the Edinburgh Postpartum Depression Scale (EDPS) questionnaire.30 The EPDS is a set of ten questions about the subject's mood in the previous seven days. Each symptom is scored on a numeric rating scale of none (0) to severe (3). Commonly employed thresholds for psychiatric referral are 10-13 out of a possible 30 points.
P30 (TMS-evoked potential)
时间窗: 4 days
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
P60 (TMS-evoked potential)
时间窗: 4 days
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Cortical evoked activity (CEA)
时间窗: 4 days
The CEA will be calculated from the area under the curve of the rectified single pulse TMS-evoked potential
Anxiety
时间窗: through postoperative day 84
This will be assessed using the General Anxiety Disorder-7 (GAD-7) questionnaire. There are 7 items scored from 0-3. The total score can range from 0 (no anxiety) - 21 (most anxiety).
Psychosocial stress
时间窗: at enrollment 1 day
This will be assessed using the Antenatal Risk Questionnaire (ANRQ). The range of scores is 5-60. A higher score indicates greater psychosocial risk.
Adverse effects - Blurred vision
时间窗: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): blurred vision.
Adverse effects - nystamus
时间窗: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): nystagmus.
N45 (TMS-evoked potential)
时间窗: 4 days
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
N100 (TMS-evoked potential)
时间窗: 4 days
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Post-Traumatic Stress Disorder (PTSD)
时间窗: through postoperative day 84
The Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire. Scores range 0 - 80. More severe PTSD scores higher.
Obstetric Quality of Recovery
时间窗: through postoperative day 84
(ObsQoR10 score, 10 items, total score 0-100)
Number of participants who successfully breastfeed their newborn baby
时间窗: 4 days
Success in any 24-hour period will be defined as when an infant breastfeeds, for 10 minutes or more in a rhythmic suck/swallow/pause/suck pattern, at least eight times in that 24-hour period.
Adverse effects - sedation
时间窗: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation.
Adverse effects - diplopia
时间窗: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): diplopia.
Adverse effects - dizziness
时间窗: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): dizziness.
Adverse effects - hallucinations
时间窗: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): hallucinations.
Antidepressant treatment
时间窗: through postoperative day 84
All current pharmacological and psychological therapies will be documented.
Adverse effects - euphoria
时间窗: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): euphoria.
Adverse effects - amnesia
时间窗: 4 days
Each of the following will be assessed on a four point scale (Not present, mild, moderate, severe): amnesia.
次要结局
未报告次要终点
研究者
David Monks
Assoc Prof of Anesthesiology, Anesthesiology
Washington University School of Medicine