Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2013-08-06
2020-08-31
Brief Summary
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Detailed Description
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The longer-term goal is to determine the relationship between clinically administered doses of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) (antidepressants), the amount of drug in the body via blood level, the concentrations of the drug achieved in brain measured via MRS, and genetics.
It has been previously reported that individuals taking 20mg of paroxetine daily had brain paroxetine \[(Paxil) levels via MRS ranging from 2-13 micromolar. Similar or slightly higher ranges of brain drug concentrations have been reported for fluoxetine and fluvoxamine.
Since not all depressed patients respond to medications, one reason may be the amount of medication that crosses the blood-brain barrier. This may be influenced by genetic information. We want to examine these issues on a larger scale, but first we need to demonstrate that we can indeed determine paroxetine \[(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)\] levels via MRS.
Intended results analysis could not be conducted because a reliably sensitive spectroscopic method could not be developed.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Major depressive disorder
There is no intervention/treatment in this study.
No interventions assigned to this group
Non-depressed individuals
There is no intervention/treatment in this study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Taking paroxetine \[(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)\]for at least 6 weeks
3. Between 21 - 75 years of age.
4. Taking a stable dose of paroxetine \[(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)\] for at least the 2 weeks prior to the imaging session
Healthy controls:
1. Between 21 - 75 years of age.
2. Have a 21-item HAM-D score of less than or equal to 5.
3. No current, or history of any Axis I disorder.
Exclusion Criteria
2. Current pregnancy or lactation.
3. Patients with claustrophobia.
4. History, or current Axis I or Axis II disorders
5. Active unstable medical problems, as confirmed by screening procedures
6. Diagnosed with any autoimmune disease, (e.g., rheumatoid arthritis, Lupus, MLS).
7. Chronic use of steroids or opiates.
8. Positive urine toxicology screen for illicit substances of abuse.
21 Years
75 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Alan Schatzberg
Professor, Department of Psychiatry and Behavioral Sciences
Locations
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Stanford University Psychiatry and Biobehavioral Sciences
Stanford, California, United States
Countries
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Other Identifiers
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28162
Identifier Type: -
Identifier Source: org_study_id
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