EUCTR2017-004823-66-NL进行中（未招募）1 期
Early-life stress, the endocannabinoid system, and fear memory extinction
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In each of the two substudies, in order to be eligible to participate in this study, a participant must meet all of the following criteria:
- •For ELS and non-ELS groups:
- •- Healthy volunteers between 18 and 45 years of age.
- •- Predominant right-handedness.
- •- History of taking cannabis.
- •For ELS group:
- •- Meet the criteria for ELS as measured using the self-report questionnaire Maltreatment and Abuse Chronology of Exposure Scale (MACE-X)”. There are 10 subscales in MACE-X, the criterion for each subscale is listed below. All types of exposure of trauma should be before ten years old. There are six subscales which are very relevant to severe childhood maltreatment: Emotional Neglect, Parental Nonverbal Emotional Abuse, Parental Physical Maltreatment, Parental Verbal Abuse, Sexual Abuse, or Witnessing Interparental Violence. Participants should reach at least one criterion of these six subscales to be included in the ELS group:
- •- In the emotional neglect subscale, the cut-off is 2 items out of 5.
- •- In the non-verbal emotional abuse subscale, the cut-off is 4 out of 6.
- •- In the parental physical maltreatment subscale, the cut-off is 4 items.
- •- In the parental verbal abuse subscale, the cut-off is 3 items out of 4.
- •- In the sexual abuse subscale, the cut-off is 2 items out of 7.
- •- In the witnessing interparental violence subscale, the cut-off is 2 items out of 5.
- •There are four subscales which are less relevant to severe childhood maltreatment. The criterion for each of these subscales is listed below. If participants only fulfil the criteria of one or more of these four subscales, they will not be included in ELS group:
- •- In the peer emotional abuse subscale, the cut-off is 4 items out of 5.
- •- In the peer physical bullying subscale, the cut-off is 2 items out of 5.
- •- In the physical neglect, the cut-off is 2 items out of 5.
- •- In the witnessing violence to siblings subscale, the cut-off is 1 items out of 4.
- •For Non-ELS group: Since we need to recruit participants in the control group with no experiences of ELS, we will include people who score 0 on the six subscales most relevant to severe childhood maltreatment (SCM) listed above. In addition, control participants need to score below the cut-off on the other four subscales less relevant to severe childhood maltreatment in the Maltreatment and Abuse Chronology of Exposure Scale (MACE-X)”.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •For both groups:
- •- Body mass index lower than 18.5 or higher than 30.
- •- Abnormal hearing or (uncorrected) vision.
- •- Average use of psychotropic medication or recreational drugs weekly or more.
- •- Habitual smoking, i.e. more than a package of cigarettes per week and a self-reported
- •inability or unease to cease smoking for 24 hours prior to testing.
- •- Use of psychotropic medication, or of recreational drugs over a period of one week prior to each test session, and use of alcohol within the last 24 hours before each measurement.
- •- Regular use of corticosteroids.
- •- History of psychiatric treatment or current psychiatric treatment. (e.g., severe mood disorders, mania, anorexia nervosa, schizophrenia or borderline personality disorder)
- •- History of neurological treatment or current neurological treatment.
- •- History of endocrine treatment or current endocrine treatment. (e.g., pheochromocytoma, hyperthyroidism, Cushing’s syndrome)
- •- History of repeated (more than once) of autonomic failure (e.g., vasovagal reflex syncope).
- •- Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, deep brain stimulation, claustrophobia)
- •- Use of medication that may interact with THC or hydrocortisone, for THC, taking Rifampicin, Ketoconazole, and Omeprazole at this moment; For Hydrocortisone, taking taking mifepristone at this moment.
- •- Cognitive impairment (MMSE < 26)
- •- Pregnancy
- •- Night shift work
研究者
相似试验
尚未招募
不适用
Early-life stress, the endocannabinoid system, and fear memory extinctioposttraumatic stress disorderNL-OMON23960Radboudumc48
已完成
2 期
Early-life stress, the endocannabinoid system, and fear memory extinctioPost Traumatic Stress DisorderTrauma-related Anxiety Disorder10002861NL-OMON50765Radboud Universitair Medisch Centrum96
已完成
不适用
Activation of the Endocannabinoid System and CognitionPost Traumatic Stress DisorderNCT05226351Charite University, Berlin, Germany192
招募中
2 期
Boosting the endocannabinoid system before the treatment of anxiety symptomsNL-OMON52231niversitair Medisch Centrum Utrecht82
招募中
Unknown
The Effect of Stress on Neuroendocrine Markers and Functional Connectivity in Children and Adolescents with Depressive and Anxiety DisordersF32.1F32.2F32.3F33.1F33.2F33.3F40.0F40.00F40.01F40.1F41.0Moderate depressive episodeSevere depressive episode without psychotic symptomsSevere depressive episode with psychotic symptomsRecurrent depressive disorder, current episode moderateRecurrent depressive disorder, current episode severe without psychotic symptomsRecurrent depressive disorder, current episode severe with psychotic symptomsSocial phobiasPanic disorder [episodic paroxysmal anxiety]AgoraphobiaDRKS00032507Klinik und Poliklinik für Kinder- und Jugendpsychiatrie der Universität Regensburg am Bezirksklinikum Regensburg90