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Neural Correlates of Psychodynamic Psychotherapy for Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychodynamic Psychotherapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Psychotherapy, Neuroimaging, Subjects with Major Depressive Disorder (MDD)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Depression Clinical and Research Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychodynamic psychotherapy

Arm Description

Outcomes

Primary Outcome Measures

Correlation between changes in HAMD-17 and changes in QEEG measurements (theta cordance) from treatment initiation to two weeks after starting treatment
PET: Treatment-related change in FDG metabolism within regions-of-interest identified at baseline as related to depression severity.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2008
Last Updated
May 9, 2013
Sponsor
Massachusetts General Hospital
Collaborators
Hope for Depression Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00812227
Brief Title
Neural Correlates of Psychodynamic Psychotherapy for Depression
Official Title
Neural Correlates of Psychodynamic Psychotherapy for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Hope for Depression Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Psychotherapy, Neuroimaging, Subjects with Major Depressive Disorder (MDD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychodynamic psychotherapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Psychodynamic Psychotherapy
Intervention Description
Screened and eligible patients will receive 16 individual sessions of psychodynamic psychotherapy, each lasting 45-50 minutes.
Primary Outcome Measure Information:
Title
Correlation between changes in HAMD-17 and changes in QEEG measurements (theta cordance) from treatment initiation to two weeks after starting treatment
Time Frame
Weeks 0 through 16
Title
PET: Treatment-related change in FDG metabolism within regions-of-interest identified at baseline as related to depression severity.
Time Frame
Week 0, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Roffman, MD
Organizational Affiliation
Massachusetts General Hospital Department of Psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Witte, MD, MPH
Organizational Affiliation
Massachusetts General Hospital Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Clinical and Research Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Neural Correlates of Psychodynamic Psychotherapy for Depression

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