Healthy Clinical Trial
Official title:
Tryptophan Depletion PET Study in Remitted Depressed Subjects and Healthy Controls, and GABA MRS Study in Remitted and Currently Depressed Subjects and Healthy Controls
Verified date | June 8, 2009 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Serotonin is a chemical involved in regulation of emotions, anxiety, sleep, stress hormones,
and other body functions. The purpose of this study is to use a procedure called tryptophan
depletion to study the function of serotonin in people with depression and in healthy
volunteers.
Major depressive disorder (MDD) has been associated with reduced functioning of central
serotonergic systems. Tryptophan depletion (TD) is a procedure used to investigate the
relationship between serotonergic function and depression. Evidence suggests that the mood
lowering effects of TD depend upon family history and differences in genes for a specific
protein called 5-HTTLPR. Healthy females with a particular gene for 5-HTTLPR and a family
history of mood disorders appear to be at a greater risk for the development of depressive
symptoms during TD. This study will use positron emission tomography (PET) scans of the brain
to investigate the effect of variant 5-HTTLPR genotypes on response to TD. The relationship
between 5-HTTLPR genotypes and the effect of TD on brain activity in individuals with
different 5-HTTLPR genes will be determined. This study will also examine how the reduced
serotonin function that occurs in MDD affects the brain's response to sensory stimulation.
Participants in this study will be screened by telephone about their psychiatric and medical
history, current emotional state, anxiety and sleep patterns, and family history of
psychiatric disorders. At study entry, participants will have an interview, physical
examination, electrocardiogram (EKG), and blood and laboratory tests. Menstruating women will
have a pregnancy test and tests to determine menstrual phase and time of ovulation. At the
second clinic visit, participants will undergo tests of intelligence and cognitive abilities
and a magnetic resonance imaging (MRI) scan of the brain. Prior to Visits 3 and 4,
participants will collect their saliva and urine. Menstruating women will have a pregnancy
test. At Visits 3 and 4, participants will undergo TD studies and PET scanning. During one of
these visits, participants will take capsules of an amino acid. On the other day, they will
take lactose capsules. Throughout the study, participants will be asked about their emotional
state, anxiety, ability to concentrate, and well being.
Status | Completed |
Enrollment | 450 |
Est. completion date | April 30, 2005 |
Est. primary completion date | April 30, 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
-INCLUSION CRITERIA - MDD Samples: 36 subjects with rMDD (ages 18-60) 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 Scales (HDRS; 21-item) scores in the non-depressed range (less than 8), and with no more than one clinically significant depressive symptom. Additional 17 subjects with current MDD will be selected for the GABA MRS study. INCLUSION CRITERIA - Healthy Control Samples: Twenty-four healthy subjects (ages 18-60) without a known personal or family history of psychiatric disorders in first-degree relatives will be selected. EXCLUSION CRITERIA: Subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 3 months prior to the studies. However, effective medications will not be discontinued for the purposes of this study. Subjects will also be excluded if they have: 1. any form of past or current psychosis; 2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders; 3. a history of drug (including benzodiazepines [BZD]) or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria) longer than 2 years; 4. current pregnancy (as documented by pregnancy testing at screening or at days of the challenge studies); f) current breast feeding (tryptophan depletion); g) are smokers; h) current suicidal ideation or behavior; i) general MRI exclusion criteria. Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (greater than 8 ounces/day for men and greater than 6 ounces/day for women) are ineligible for participation. j) other current axis I diagnoses beside unipolar major depressive disorder; k) lactose intolerance (tryptophan depletion). Subjects beyond the age of 60 are excluded. Subjects whose first major depressive episodes arose temporally after other medical or psychiatric conditions will also be excluded. |
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,
Bowen DM, Najlerahim A, Procter AW, Francis PT, Murphy E. Circumscribed changes of the cerebral cortex in neuropsychiatric disorders of later life. Proc Natl Acad Sci U S A. 1989 Dec;86(23):9504-8. — View Citation
Coppen A, Eccleston EG, Peet M. Total and free tryptophan concentration in the plasma of depressive patients. Lancet. 1973 Jul 14;2(7820):60-3. — View Citation
Rajkowska G, Miguel-Hidalgo JJ, Wei J, Dilley G, Pittman SD, Meltzer HY, Overholser JC, Roth BL, Stockmeier CA. Morphometric evidence for neuronal and glial prefrontal cell pathology in major depression. Biol Psychiatry. 1999 May 1;45(9):1085-98. — View Citation
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