Major Depressive Disorder Clinical Trial
Official title:
FMRI Study of Performance During a Probabilistic Reversal Learning Task in Depression
Verified date | April 21, 2008 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will examine how the brains of depressed people function during learning and
respond to feedback. Participants perform a "probabilistic reversal learning task" to
determine whether depressed people perform worse on a task than non-depressed people when
they sometimes receive misleading negative feedback.
Right-handed healthy volunteers, people with major depression who are currently depressed or
have previously been depressed and people with bipolar depression between 18 and 50 years of
age may be eligible for this study. Candidates are screened with a medical and psychiatric
history, physical examination, electrocardiogram, blood and urine tests. They are also
interviewed to evaluate mood, sleep, energy, work and school performance, and social
relationships, and asked to answer questions to investigate whether any history of paranoia,
panic attacks, obsession, compulsions, suicidal thoughts, eating disturbances, and alcohol or
drug abuse is present. They complete rating scales for depression, anxiety, and negative
thinking; history of alcohol and tobacco use; physical movement; socioeconomic status;
overall level of functioning; and depression type. Finally, they undergo a battery of
neuropsychological tests to assess general intelligence, handedness, and specific cognitive
abilities, including memory and concentration.
Participants perform the probabilistic reversal learning task either in a testing room seated
in front of a computer or lying down while undergoing functional magnetic resonance imaging
(FMRI). FMRI is a diagnostic test that uses a strong magnet and radio waves to obtain
pictures of brain structure and function. For the scan, the subject lies on a narrow bed with
a plastic-encased metal coil close to the head. The bed slides into the scanner - a small
tunnel about 6 feet long. All subjects, whether in the testing room or in the MRI scanner,
undergo the learning task as follows:
Two patterns are presented on a computer screen. One pattern is designated "correct" and the
other "incorrect." Subjects are asked to choose the correct pattern on each try and are
provided feedback as to whether the response was right or wrong. Sometimes the rule changes,
and the pattern that was correct is now wrong, and vice versa, so that the new correct
pattern must be chosen. In addition, misleading feedback is sometimes given intentionally,
indicating the subject chose the wrong pattern when in fact the response was correct.
Subjects should change their response only when they are sure that the rule has changed, and
not because they were incorrectly told that they were wrong. For patients undergoing MRI,
blood flow in the different areas of the brain is measured during the test.
After the test, outside the scanner, participants undergo additional tests of attention,
memory, and concentration like those that were administered during the screening procedures.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 21, 2008 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
- INCLUSION CRITERIA: All subjects will be between 18 and 50 years old. Male and female subjects will be included. All subjects must be able to give written informed consent prior to participation in this study. MDD Depressed Sample: Twenty five subjects (ages 18-50) male and female will be selected, with primary MDD currently depressed as defined by DSM-IV criteria for recurrent MDD, in a current major depressive episode and who have a first degree relative with MDD but no first degree relatives with mania, alcoholism, or antisocial personality disorder. MDD Remission Sample: Twenty subjects (ages 18-50) male and female will be selected. Remission is defined as a period of at least three months during which the subject has not taken an antidepressant agent, with Hamilton Depression Rating Scale (HDRS; 21-item; Hamilton 1960) scores in the non-depressed range (less than 8), and with no more than one clinically significant depressive symptom. Bipolar Depressed Sample: Twenty five subjects (ages 18-50) male and female will be selected who meet DSM-IV criteria for bipolar I or II disorder and are currently in a depressed phase. Healthy Control Sample: Thirty subjects (ages 18-50) male and female who have not met criteria for any major psychiatric disorder will be selected. From this large sample a control subject will be matched to each depressed subject for age, gender, handedness and IQ. The control subjects will have no known first degree relatives with mood disorders. EXCLUSION CRITERIA: Individuals with any major medical or neurological disorder or who have received psychotropic drugs or medication likely to influence cerebral blood flow or metabolism within 3 weeks (8 weeks for fluoxetine [Prozac]), of scanning. Bipolar subjects with rapid cycling or with current psychosis will be excluded from the protocol. Effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry. Individuals who meet DSM-IV criteria for alcohol and/or substance abuse within 1 year prior to screening or lifetime history of substance dependence. Women of childbearing potential who are known to be pregnant or who have a positive pregnancy test. Individuals who have experienced serious suicidal ideation within the past 2 months. General exclusions for MRI imaging, such as having had a cardiac pacemaker or ferromagnetic object implanted through surgical intervention or accident (for example: shrapnel). |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |