Magnetic Resonance Spectroscopy and Medication Response: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Stanford University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations.
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed patients.
Detailed Description
The primary objective of this study is to demonstrate that it is feasible to image paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed patients. 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.
Investigators
Alan Schatzberg
Professor, Department of Psychiatry and Behavioral Sciences
Stanford University
Eligibility Criteria
Inclusion Criteria
- •DSM diagnosis of Major Depressive Disorder
- •Taking paroxetine \[(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)\]for at least 6 weeks
- •Between 21 - 75 years of age.
- •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:
- •Between 21 - 75 years of age.
- •Have a 21-item HAM-D score of less than or equal to
- •No current, or history of any Axis I disorder.
- •Identify exclusion criteria.
- •Exclusion criteria are as follows:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations.
Time Frame: Within 7 Days following MRS
Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed participants.