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临床试验/NCT01390389
NCT01390389已完成不适用

Exploring the Effects of Coenzyme Q10 on Bioenergetics Metabolism in Geriatric Bipolar Depression: A 31 Phosphorus MR Spectroscopy Study

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline

研究概览

简要总结

The investigators propose to study and compare measures of brain energy metabolism in geriatric bipolar individuals and healthy older adults. The investigators would also like to investigate changes in brain energy metabolites associated with CoQ10 administration in older bipolar individuals. Finally, resting state functional Magnetic Resonance Imaging (fMRI) will be conducted in order to explore frontal and limbic circuitry in geriatric bipolar disorder.

  • Primary Hypothesis: Baseline beta NTP and NAA will be lower, and PCr and lactate higher in Geri BPD compared with older healthy controls
  • Secondary Hypothesis: Changes in PCr and beta NTP will be demonstrated in Geri BD group challenged with CoQ 10.

详细描述

Research Design and Methods:

Bipolar Depressed Subjects:

The Bipolar Depressed group will consist of 10 subjects (for the purposes of this study we would like to be able to recruit up to 30 subjects, with the goal of getting 10 to complete the protocol), ages 55-89, meeting DSM IV-TR criteria for bipolar disorder, current episode depressed, with depression severity rated by the MADRS and the Clinical Global Impression of severity scale (CGI). The Young Mania Rating Scale (YMRS) will be used to assess concomitant manic symptoms and neuropsychological measures to assess cognitive status. Subjects with any current or previous Axis I disorder diagnosis other than Bipolar Disorder, including dementia, unstable medical illness or any contraindications to magnetic resonance imaging (MRI) will be excluded. Subjects may be concurrently prescribed other psychotropic medications, but dosages must be unchanged for one week prior to study entry and subjects must be willing to continue these medications during the study. All subjects must be able to provide written informed consent. Furthermore, subjects will be asked to complete a demographic information form.

Recruitment will take place through referrals from the McLean Hospital Geriatric Psychiatry Inpatient Service, Geriatric Psychiatry Outpatient Program: SAGE (Seniors Aging Gracefully Everyday) the Geriatric Psychiatry Outpatient Clinic, other inpatient, partial and outpatient psychiatric programs at McLean Hospital, the Cambridge Health Alliance, local geriatricians, the Harvard Division on Aging, local retirement communities, community psychiatrists, Partners Community Health Care PCP's, Massachusetts General Hospital and Brigham and Women's PCP network and similar external programs, as well as through radio and internet advertisements. We have obtained permission from the directors of both the Inpatient Service (Older Adult Unit) and Geriatric Psychiatry Outpatient Program (SAGE Program) to have a research assistant look through patient charts to identity eligible subjects. Once a potential subject has been identified, study staff will discuss the possibility of study participation with the patient's doctor to see if the study would be appropriate. If the doctor agrees about the patient's eligibility, the doctor will discuss the study with the patient and refer patients who are interested in participating to a member of our study staff.

Inclusion Criteria:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
55 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

CoQ10

Experimental

Subjects who meet DSM-IV diagnostic criteria for Bipolar Disorder, Current Episode Depressed are assigned to this arm and administered the Coenzyme Q10 intervention. CoQ10 dosing guidelines:

  • Visit 1 (Baseline) start at 400mg once a day for two weeks
  • Visit 2 (within 7 days of Baseline visit) increase to 800 mg once a day for two weeks

The dosage of CoQ10 can be titrated in a more gradual manner depending on clinical response and tolerability of the medication, but cannot be titrated any more rapidly than the schedule above.

干预措施: Coenzyme Q10 (Drug)

结局指标

主要结局

Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline

时间窗: Baseline

Tissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.

次要结局

  • To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.(4-week trial)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brent Forester

PI

Mclean Hospital

研究点 (1)

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