MRS and Medication Response: A Pilot Study

Stanford University

Status: Terminated

Conditions: Major Depressive Disorder; Major Depressive Episode; Major Depression Moderate; Major Depression Mild; Major Depression Severe; Major Depressive Disorder, Recurrent

Study type: Observational

Funder types: Other

Identifiers

NCT03254342

28162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Major depressive disorder:

Inclusion Criteria:

1. DSM diagnosis of Major Depressive Disorder
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.

Identify exclusion criteria.

Exclusion criteria are as follows:

1. Contraindications for an MRI exam. These includes biomedical devices such as pacemakers, aneurysm clips, prostheses, and other metallic objects embedded in the body such as bullets, buckshot, shrapnel, and any metal fragments from working around metal.
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.

Trial design

3 participants in 2 patient groups

Major depressive disorder

Description:

There is no intervention/treatment in this study.

Non-depressed individuals

Description:

There is no intervention/treatment in this study.