Neural Correlates of Psychodynamic Psychotherapy for Depression

NCT00812227 | Completed

• 1 other identifier: 2008-P-001181
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Psychotherapy; Neuroimaging; Subjects with Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (2)

• Correlation between changes in HAMD-17 and changes in QEEG measurements (theta cordance) from treatment initiation to two weeks after starting treatment

  Weeks 0 through 16

• PET: Treatment-related change in FDG metabolism within regions-of-interest identified at baseline as related to depression severity.

  Week 0, Week 16

Study Arms (1)

Psychodynamic psychotherapy

EXPERIMENTAL

Behavioral: Psychodynamic Psychotherapy

Interventions

Psychodynamic Psychotherapy BEHAVIORAL

Screened and eligible patients will receive 16 individual sessions of psychodynamic psychotherapy, each lasting 45-50 minutes.

Psychodynamic psychotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Hope for Depression Research Foundation: collaborator

Study Sites (1)

Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Psychotherapy, Psychodynamic

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joshua Roffman, MD

  Massachusetts General Hospital Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Janet Witte, MD, MPH

  Massachusetts General Hospital Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff psychiatrist

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

US (1)