Trials / Terminated
TerminatedNCT03254342
MRS and Medication Response: A Pilot Study
Magnetic Resonance Spectroscopy and Medication Response: A Pilot Study
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 3 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Major Depressive Disorder
- Major Depressive Episode
- Major Depressive Disorder, Recurrent
- Major Depression Mild
- Major Depression Moderate
- Major Depression Severe
Timeline
- Start date
- 2013-08-06
- Primary completion
- 2020-08-06
- Completion
- 2020-08-31
- First posted
- 2017-08-18
- Last updated
- 2021-08-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03254342. Inclusion in this directory is not an endorsement.