- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00183755
Understanding Brain Reward Responses in Individuals With Major Depressive Disorder
Neuroimaging Studies of Reward Processing in Depression
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Major depressive disorder (MDD) is a severe form of depression that can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD may experience anhedonia, or the inability to gain pleasure from normally pleasurable experiences. Such individuals do not respond to motivational rewards in the same way as do individuals who are not depressed. Anhedonia has been recognized as a core symptom of depression and it is not always remedied with antidepressant medication. Abnormal brain activity and processing may be the underlying cause of depression and specifically anhedonia. A better understanding of the brain mechanisms of depression may lead to the development of new effective medications or psychological treatments.
Event-related potential (ERP), which measures electrical activity in the brain, and functional magnetic resonance imaging (fMRI), which uses scanned images to illustrate changes in brain activity, are two techniques that can identify abnormal areas of brain processing. The purpose of this study is to use ERP and fMRI to compare brain activity that is related to reward processing in individuals with MDD versus individuals without MDD.
This study will consist of 3 study visits; visits will be scheduled as close together as possible. At the first study visit, potential participants will be assessed with the SCID (Structured Clinical Interview for DSM-IV), which will identify individuals with the diagnostic criteria for MDD. A control group of non-depressed individuals will also be enrolled in the study. During the second and third study visits, participants will take part in a monetary reinforcement reward task followed by a signal detection reward task. Brain activity of all participants will be monitored during both tasks. During the second study visit, ERP will be used; during the third study visit, fMRI will be used. Demographic information will also be collected, and participants will complete several standardized questionnaires to assess mood. Some participants will be asked to return after eight weeks to complete the fMRI and EEG sessions again. Those who do complete all five sessions will be awarded a bonus.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- The Depression Clinical and Research Program, Massachusetts General Hospital
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Cambridge, Massachusetts, Vereinigte Staaten, 02138
- Affective Neuroscience Laboratory, Department of Psychology, Harvard University
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Charlestown, Massachusetts, Vereinigte Staaten, 02129
- Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Overall Inclusion Criteria:
- Right-handed
- Agrees to use an effective form of contraception throughout the study
Inclusion Criteria for Depressed Participants:
- Meets overall inclusion criteria
- Meets DSM-IV diagnosis criteria for major depressive disorder
- Score of at least 16 on the 21-item HAM-D scale
Overall Exclusion Criteria:
- Left-handed or ambidextrous
- Claustrophobic
- Neurological or medical illness (e.g., attention deficit hyperactivity disorder, head injury, loss of consciousness, seizures)
- Pregnant
Exclusion Criteria for Depressed Participants:
- Meets any of the overall exclusion criteria
- Has been treated with electroconvulsive therapy within 6 months of study entry
- Has taken any benzodiazepine medications for at least 2 weeks prior to study entry and discontinued use of the medication for reasons other than participating in the study
- Has taken any dopaminergic medications (including methylphenidate) or neuroleptics for at least 6 months prior to study entry and discontinued use of the medication for reasons other than participating in the study
- Has taken any fluoxetine medications for at least 6 weeks prior to study entry and discontinued use of the medication for reasons other than participating in the study
- Has taken any medications that may have antidepressant properties (including some herbal supplements) within 2 weeks of study entry
- Has taken any medications that may affect blood flow (including some blood pressure medications) within 2 weeks of study entry
- Current or past history of MDD with psychotic features
- Meets DSM-IV diagnosis criteria for organic mental disorder; substance use disorder (within 1 year of study entry); lifetime substance dependence; schizophrenia; delusional disorder; bipolar disorder; post-traumatic stress disorder; eating disorder; acute bereavement; severe borderline or antisocial personality disorder; or any psychotic disorder not otherwise specified
- Current primary diagnosis of panic disorder, social phobia, generalized anxiety disorder, obsessive-compulsive disorder, or somatoform disorder
Exclusion Criteria for Control Participants
- Meets any of the overall exclusion criteria
- Diagnosed with any medical or neurological illness
- Diagnosed with any current or past psychiatric illness, as assessed by the SCID-I, including substance abuse or dependence (e.g., alcohol)
- Has taken any medications that may have antidepressant properties (including some herbal supplements) within 2 weeks of study entry
- Has taken any psychotropic medications within 2 weeks of study entry
- Has taken any medications that may affect blood flow (including some blood pressure medications) within 2 weeks of study entry
Exclusion Criteria for fMRI Studies:
- Meets any of the overall exclusion criteria
- Fails to meet safety standards for fMRI
- Current back problems
- Has strongly corrected vision, but does not wear contact lenses
- Weighs more than 250 pounds or exceeds the limit of height-to-weight ratio for a comfortable fit in the scanner
- Pregnant
- Current alcohol or substance abuse
- At risk for suicide or homicide
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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1
Control participants
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2
Participants with MDD
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Performance on Monetary Incentive Delay task
Zeitfenster: Given once during the second session for half an hour, and once during the third session for half an hour
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This task features balanced incentive delivery and analytic strategies designed to identify activity specific to anticipation or consumption of incentives.
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Given once during the second session for half an hour, and once during the third session for half an hour
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Signal detection reward task
Zeitfenster: Given once during the second session for fifteen minutes, and once during the third session for fifteen minutes
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This reward task provides an objective assessment of hedonic capacity.
Due to the probabilistic nature of the task, participants cannot infer which stimulus is more advantageous based on the outcome of single trials but need to integrate reinforcement history over time to optimize behavior.
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Given once during the second session for fifteen minutes, and once during the third session for fifteen minutes
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Diego A. Pizzagalli, PhD, Harvard University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R01MH068376 (US NIH Stipendium/Vertrag)
- DATR A3-NSS (Indiana University)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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