MRS and Medication Response: A Pilot Study
Magnetic Resonance Spectroscopy and Medication Response: A Pilot Study
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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Stanford, California, Forenede Stater, 94305
- Stanford University Psychiatry and Biobehavioral Sciences
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Major depressive disorder:
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 5.
- No current, or history of any Axis I disorder.
Identify exclusion criteria.
Exclusion criteria are as follows:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Major depressive disorder
There is no intervention/treatment in this study.
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Non-depressed individuals
There is no intervention/treatment in this study.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations.
Tidsramme: Within 7 Days following MRS
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Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed participants.
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Within 7 Days following MRS
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 28162
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Kliniske forsøg med Større depressiv lidelse
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Seasons Biotechnology (Taizhou) Co., Ltd.AfsluttetMajor Depressive Disorder (MDD)Indien
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Repurposed Therapeutics, Inc.Ukendt
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GlaxoSmithKlineAfsluttetMajor Depressive Disorder (MDD)Forenede Stater
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AccexibleRekrutteringMajor Depressive Disorder (MDD)Spanien
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Ikke rekrutterer endnuMajor Depressive Disorder (MDD)
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RekrutteringMajor Depressive Disorder (MDD)Kina