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- Klinische proef NCT00812227
Neural Correlates of Psychodynamic Psychotherapy for Depression
9 mei 2013 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
35
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Depression Clinical and Research Program
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Psychodynamic psychotherapy
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Screened and eligible patients will receive 16 individual sessions of psychodynamic psychotherapy, each lasting 45-50 minutes.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Correlation between changes in HAMD-17 and changes in QEEG measurements (theta cordance) from treatment initiation to two weeks after starting treatment
Tijdsspanne: Weeks 0 through 16
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Weeks 0 through 16
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PET: Treatment-related change in FDG metabolism within regions-of-interest identified at baseline as related to depression severity.
Tijdsspanne: Week 0, Week 16
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Week 0, Week 16
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Joshua Roffman, MD, Massachusetts General Hospital Department of Psychiatry
- Hoofdonderzoeker: Janet Witte, MD, MPH, Massachusetts General Hospital Department of Psychiatry
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2008
Primaire voltooiing (Werkelijk)
1 februari 2013
Studie voltooiing (Werkelijk)
1 februari 2013
Studieregistratiedata
Eerst ingediend
18 december 2008
Eerst ingediend dat voldeed aan de QC-criteria
19 december 2008
Eerst geplaatst (Schatting)
22 december 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
13 mei 2013
Laatste update ingediend die voldeed aan QC-criteria
9 mei 2013
Laatst geverifieerd
1 mei 2013
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2008-P-001181
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .