Pharmacological Modulation of Hippocampal Activity in Psychosis 2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV)
研究概览
简要总结
The purpose of this study is to test whether administration of levetiracetam (LEV), a commonly used anti-epileptic that alters neurotransmitter release, can reduce hippocampal hyperactivity in people with psychotic disorders. Specifically, the investigators will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood-oxygen-level-dependent (BOLD) contrast will assess activity with a visual scene processing task that engages the anterior hippocampus and 2) arterial spin labeling (ASL) will assess baseline activity. Previous studies in people with psychotic disorders have shown that the hippocampus is hyperactive and more activity correlates with worsening of clinical symptoms. Therefore, the aim of this study is to use an intervention to further understand the underlying mechanisms of the hippocampus in psychosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
During Visit 2, participants will be randomly assigned to an intervention arm in which they will receive two 250mg LEV capsules or two placebo capsules. Both the participant and the research team will be blinded to which arm each participant is in. During Visit 3, the participant will undergo cross-over and receive either two 250mg LEV capsules or two placebo capsules (whichever intervention they did not receive in Visit 2).
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
- 是
入选标准
- •Inclusion criteria for psychosis subjects
- •Men and women age 18 -
- •Communicative in English.
- •Provide voluntary, written informed consent.
- •Physically healthy by medical history.
- •BMI > 17.5 and <
- •Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID) or diagnostic interview with a trained clinician.
- •Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
- •For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study (e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository; male partner sterilization; or true abstinence when this is in line with the preferred and usual lifestyle of the subject); and,
- •For females of child-bearing potential, must have a negative urine pregnancy test before MRI and drug administration.
- •Not breastfeeding/nursing at time of screening or at any time during the study.
- •Inclusion criteria for healthy controls
- •All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.
排除标准
- •Exclusion criteria for psychosis subjects
- •Age less than 18 or greater than
- •Not communicative in English.
- •Unable to provide written informed consent.
- •Current medical or neurological illness.
- •History of severe head trauma.
- •BMI < 17.5 or >
- •Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
- •Positive urine pregnancy test during the study.
- •Breastfeeding/nursing at time of screening or at any time during the study.
- •Conditions that preclude MR scanning (as defined in the Screening Form)
- •Conditions that preclude study drug administration (as defined in the Screening Form)
- •Exclusion criteria for healthy controls
- •All of the above and in addition:
- •Current use of psychotropic or potentially psychoactive prescription medication.
- •Major psychiatric disorder as determined by Diagnostic and Statistical Manual -5 (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)
研究组 & 干预措施
Levetiracetam (LEV), then Placebo
Participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.
干预措施: Levetiracetam (LEV) 500 mg (Drug)
Levetiracetam (LEV), then Placebo
Participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.
干预措施: Placebo (Drug)
Placebo, then Levetiracetam (LEV)
Participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.
干预措施: Levetiracetam (LEV) 500 mg (Drug)
Placebo, then Levetiracetam (LEV)
Participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.
干预措施: Placebo (Drug)
结局指标
主要结局
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV)
时间窗: 2 hours after LEV administration
ASL signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo
时间窗: 2 hours after placebo administration
ASL signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Placebo
时间窗: 2 hours after placebo administration
BOLD signal after placebo, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus.
Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV)
时间窗: 2 hours after LEV administration
BOLD signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. This method reflects changes in oxygenation of blood in the brain during a scene-processing task that engages, or recruits, the hippocampus.
次要结局
未报告次要终点
研究者
Stephan Heckers
Dept Chairperson Professor
Vanderbilt University Medical Center