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Neural Correlates of Psychodynamic Psychotherapy for Depression

2013年5月9日 更新者:Joshua L. Roffman MD, MMSc、Massachusetts General Hospital
The purpose of this study is to see whether we can predict which patients with depression will get better when we treat them with psychodynamic psychotherapy. We will use neuroimaging (a method of looking at brain activity) in this study. We want to see whether there are changes in the brains of patients receiving this type of therapy. We hypothesize that these changes may predict how well certain parts of the psychotherapy treatment process works.

研究概览

地位

完全的

详细说明

In this study, we will treat patients with brief psychodynamic psychotherapy. Psychodynamic psychotherapy is a type of treatment that may be as helpful as medications in treating depression. It focuses on thoughts, feelings, and behaviors as well as both current and past relationships. Psychotherapy explores better ways of coping with feelings, expressing needs, and interacting with others in order to cope with depression and other life problems. Subjects will go to 16 weekly, 45-minute, individual sessions of psychodynamic psychotherapy over the course of the study. At five times throughout the study, subjects will come in for extra visits, which last approximately 1.5 hours and which include: speaking with a study doctor about depressive symptoms, filling out extra questionnaires, and performing positron emission tomography (PET)and a Quantitative Electroencephalogram (QEEG). The QEEG is a machine that measures the electrical activity of the brain. This task will take approximately 15 minutes.

研究类型

介入性

注册 (实际的)

35

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Depression Clinical and Research Program

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects will be adults, ages 18 to 60 years;
  • Able to provide written informed consent;
  • MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV);
  • QIDS-SR score of >= 12 at screen;
  • Current major depressive episode (MDE) length of < 5 year;
  • Treated with an SSRI, SNRI, or bupropion at adequate doses (defined as 20 mg/day or more of fluoxetine, citalopram, or paroxetine; 10 mg/day or more of escitalopram; 50 mg/day or more of sertraline; 75 mg/day or more of venlafaxine; 15 mg/day of mirtazapine; or 40 mg/day of duloxetine; or 100mg/day of bupropion(wellbutrin)) during the current episode for at least 8 weeks; and,
  • At the time of screen visit, patients must be on a stable dose of SSRI, SNRI, or bupropion for the past 4 weeks.

Exclusion Criteria:

  • Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy). Women of childbearing age who wish to enter the study will be required to undergo a pregnancy test (beta-HCG) prior to initiating treatment; an additional blood pregnancy test (beta HCG) will be completed if subject wants to do PET scan
  • Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk. These patients will be immediately referred to appropriate clinical treatment;
  • Patients who, in the opinion of the therapist, are not depressed at the time of their first psychotherapy visit;
  • Patients who are currently being treated by a psychotherapist individually or who have received individual psychotherapy during the past 6 months. Couples therapy and family therapy will not be considered exclusionary criteria;
  • Patients with neurological illnesses, including a history of seizure or head trauma with loss of consciousness;
  • Patients with unstable diabetes, kidney disease, or significant medical illness;
  • Patients with history of allergy to FDG
  • The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past), any post-traumatic stress disorder (current or past), any obsessive compulsive disorder (current or past), or any panic disorder (current, past allowed). Generalized anxiety disorder or adjustment disorder are not exclusionary;
  • Patients currently requiring other psychotropic medications, including anticonvulsants, benzodiazepines, antipsychotics, stimulants, or sedative hypnotics (other than diphenhydramine);however, patients will be permitted to take trazodone in addition to their primary antidepressant if it is taken as a sleep aid, rather than a primary antidepressant;
  • Psychotic features in the current episode, or a history of psychotic features, as assessed by SCID;
  • Patients who have undergone > 3 previous adequate attempts at psychodynamic psychotherapy (deemed "adequate" by the screening physician), which were considered unhelpful or unsuccessful by patient report (according to patient report);
  • Patients with a history of antidepressant-induced hypomania; and
  • Patients with a history of medication non-compliance.
  • Patients with Axis II pathology (personality disorder) that, in the opinion of the screening physician, would interfere with subjects' ability to participate in the treatment and/or comply with the protocol, such as severe borderline or narcissistic personality disorder.
  • Patients who have had electroconvulsive therapy (ECT) within the 12 months preceding baseline

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Psychodynamic psychotherapy
Screened and eligible patients will receive 16 individual sessions of psychodynamic psychotherapy, each lasting 45-50 minutes.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Correlation between changes in HAMD-17 and changes in QEEG measurements (theta cordance) from treatment initiation to two weeks after starting treatment
大体时间:Weeks 0 through 16
Weeks 0 through 16
PET: Treatment-related change in FDG metabolism within regions-of-interest identified at baseline as related to depression severity.
大体时间:Week 0, Week 16
Week 0, Week 16

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Joshua Roffman, MD、Massachusetts General Hospital Department of Psychiatry
  • 首席研究员:Janet Witte, MD, MPH、Massachusetts General Hospital Department of Psychiatry

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年8月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年2月1日

研究注册日期

首次提交

2008年12月18日

首先提交符合 QC 标准的

2008年12月19日

首次发布 (估计)

2008年12月22日

研究记录更新

最后更新发布 (估计)

2013年5月13日

上次提交的符合 QC 标准的更新

2013年5月9日

最后验证

2013年5月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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