Neural Correlates of Psychodynamic Psychotherapy for Depression
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Depression Clinical and Research Program
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Psychodynamic psychotherapy
|
Screened and eligible patients will receive 16 individual sessions of psychodynamic psychotherapy, each lasting 45-50 minutes.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Weeks 0 through 16
|
|
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
|
Week 0, Week 16
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Joshua Roffman, MD, Massachusetts General Hospital Department of Psychiatry
- Principal Investigator: Janet Witte, MD, MPH, Massachusetts General Hospital Department of Psychiatry
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2008-P-001181
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.