ACTRN12616000131459已完成2 期
Does propranolol--compared to a placebo--affect memory performance in an emotional memory task conducted in healthy adults?
Alain Brunet, PhD0 个研究点目标入组 36 人开始时间: 2016年2月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •a. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
- •b. Male or female subjects aged 18 to 65 years at the time of consent;
- •c. Female subjects must not be childbearing or of childbearing potential (i.e., they must be either surgically sterile, under an acceptable method of birth control, fully sexually abstinent or be one year post last menstrual period). Female subjects must meet all of the following criteria:
- •*Agree to avoid pregnancy during the study;
- •*Use one of the birth control methods listed below for the duration of the trial. Preferred methods of birth control include:
- •i. An oral contraceptive agent, implantable contraceptive (e.g., Norplant) or an injectable contraceptive (e.g., Depo Provera) for at least one month prior to entering the study or prior to having sexual relations during the study and will continue its use throughout the study, or
- •ii. An intrauterine device, or
- •iii. Partner has had a vasectomy at least 3 months prior to study start.
- •*Also allowed:
- •i. A latex condom
- •ii. A double barrier method of a diaphragm with spermicide, plus a latex condom, or
- •iii. Agree to abstain from sex for the duration of the trial;
- •d. Individuals who consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to enrolment;
- •e. Individuals treated with the following medications must be on stable doses for at least 1-month prior to the screening visit and during the entire study: anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics;
- •f. Individuals taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin–Norepinephrine Reuptake Inhibitors (SNRIs), such as venlafaxine, must accept to skip their morning dose the day of each study visit;
- •g. Individuals shall not start taking new medications on a regular basis during the study. Case-by-case decisions will be made in collaboration with the study physician regarding participants who cannot comply with this criterion;
- •h. Fluency in French or English;
排除标准
- •a. Systolic blood pressure <100 mm Hg;
- •b. Cardiac rhythm below 55 beats per minute;
- •c. A medical condition that contraindicates the administration of propranolol, e.g., Asthma, chronic obstructive pulmonary disease, cardiac insufficiency, second- or third-degree atrioventricular block, spastic angina, auricular sinus illness, bradycardia, Raynaud’s disease, severe peripheral vascular disease, untreated Pheochromocytoma, arterial hypotension, previous anaphylactic allergic shock;
- •d. Previous adverse reaction to, or non-compliance with, beta-blocker;
- •e. Current use of medication that may involve potentially dangerous interactions with propranolol, including, other beta-blockers, antiarrhythmics, calcium channel blockers, and Potent P450 2D6 inhibitors, (e.g., fluoxetine, paroxetine, miconazole, sulconazole, metoclopramide, quinidine, ticlopidine, and ritnavir), clonidine, insulin, sulfonylureas, lidocaine, iodine contrast agents for medical imaging, imipramine or tricyclic antidepressants. SSRIs and SNRIs are may be used during the study (see inclusion criteria f);
- •f. Women who are pregnant or breast feeding;
- •g. The following psychiatric conditions: Past or present bipolar disorder or psychosis;
- •h. Individuals with a substance dependence or substance abuse problem;
- •i. Subjects judged (based on history, mental status exam, or clinical impression, as being at significant risk of self-injurious/suicidal behaviour;
- •k. Subjects having received a previous or present diagnosis of post-traumatic stress disorder (PTSD);
- •l. Participation in another drug trial within 30 days prior to the screening visit or during the study;
- •m. Any condition that can significantly affect the absorption of the study medication.
- •n. Presence of any clinical or medical condition that might interfere with the interpretation of the efficacy and safety results.
- •o. Previous exposure/familiarity to IAPS. Individuals participating in this study cannot be familiar with the IAPS as having any previous memory of the pictorial stimuli shown during the experiment could have an effect on the scientific validity of the study results.
- •p. If you the participant is easily affected by emotionally stimulating images.
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