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NCT00097175
Effects of Tryptophan Depletion on Brain Processing of Emotions in Patients With Mood Disorders
trial in Depressive Disorder, Major in 95 participants. Completed in 15 January 2014.
Quick facts
| Lead sponsor | National Institute of Mental Health (NIMH) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 95 |
| Start date | 10 November 2004 |
| Estimated completion | 15 January 2014 |
| Sites | 1 location across United States |
Conditions studied
- Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
Sponsor
National Institute of Mental Health (NIMH)
Who can join
Adults 18 to 50, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will investigate how the brain process emotions in healthy people and in patients who have major depression in order to better understand the causes of depression. It will examine what happens in the brain when a person responds to words related to different emotions while the brain's ability to manufacture a chemical called serotonin is reduced. Serotonin regulates functions such as emotion, anxiety and sleep, and stress hormones such as cortisol. In this study, participants' serotonin levels are reduced by depleting tryptophan, an amino acid that is the main building block for serotonin. Healthy volunteers and patients with major depression that has been in remission for at least 3 months may be eligible for this study. Candidates must be between 18 and 50 years of age and right-handed. They are interviewed about their medical and psychiatric history, current emotional state and sleep pattern, and family history of psychiatric disorders. Screening also includes psychiatric interviews and rating scales, neuropsychological tests, physical examination, electrocardiogram (EKG), and blood, urine, and saliva tests. Women have their menstrual phase determined by a blood test and home urine ovulation test kit. The study involves two clinic visits in which participants undergo tryptophan depletion and magnetic resonance imaging (MRI). Subjects arrive at the NIH Clinical Center in the morning after fasting overnight. They fill out questionnaires have a blood sample drawn, and then take 74 capsules that contain a mixture of amino acids found in the diet. At one visit they are given capsules that contain a balanced mixture of amino acids one would normally eat in a day; at the other visit, some of the capsules contain lactose instead of tryptophan, causing tryptophan depletion. At 2 p.m. participants fill out the same questionnaires they completed at the beginning of the day and have another blood sample drawn. Then they do a computerized test in the MRI scanner. MRI uses a magnet and radio waves to obtain pictures of the brain. For the test, subjects lie on a narrow bed that slides into the cylindrical MRI scanner. They are asked to press a button in response to words associated with different emotions that appear on a screen. Arterial spin labeling - a test that uses magnetism to measure blood flow in different areas of the brain-is also done during the procedure. After the scan, subjects eat a meal and then return home. DNA from the participants' blood samples is also examined to try to better understand the genetic causes of depression. Some of the white cells from the samples may also be grown in the laboratory so that additional studies can be done later. ...
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00097175
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00097175 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Mental Health (NIMH)
- Last refreshed: 12 December 2019
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