MRS and Medication Response: A Pilot Study

NCT03254342 | Terminated DMC

• 1 other identifier: 28162
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations.

  Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed participants.

  Within 7 Days following MRS

Study Arms (2)

Major depressive disorder

There is no intervention/treatment in this study.

Non-depressed individuals

There is no intervention/treatment in this study.

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Psychiatry clinic; local community.

You may qualify if:

• 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 5.
• No current, or history of any Axis I disorder.

You may not qualify if:

• 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.
• Current pregnancy or lactation.
• Patients with claustrophobia.
• History, or current Axis I or Axis II disorders
• Active unstable medical problems, as confirmed by screening procedures
• Diagnosed with any autoimmune disease, (e.g., rheumatoid arthritis, Lupus, MLS).
• Chronic use of steroids or opiates.
• Positive urine toxicology screen for illicit substances of abuse.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Psychiatry and Biobehavioral Sciences

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: August 6, 2013
• Primary Completion: August 6, 2020
• Study Completion: August 31, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)