Major Depressive DisorderNCT03254342
MRS and Medication Response: A Pilot Study
An observational study of Major Depressive Disorder and Major Depressive Episode, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Major Depressive Episode, Major Depressive Disorder, Recurrent
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2013to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Psychiatry clinic; local community.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Psychiatry and Biobehavioral Sciences
Stanford, California, 94305
About this study
Official title: Magnetic Resonance Spectroscopy and Medication Response: A Pilot Study
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.
Read the 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
- Medical subject headings
- Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major depressive disorder | There is no intervention/treatment in this study. | |
| Non-depressed individuals | There is no intervention/treatment in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 Days following MRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start6 Aug 2013
- Primary completion6 Aug 2020
- Study completion31 Aug 2020
Why it stopped: Unable to obtain a reliable MRS signal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Schatzberg, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254342
- Sponsor's protocol ID
- 28162
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2017
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Currently there is no plan.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopy and Medication Response: A Pilot Study
- ClinicalTrials.gov ID
- NCT03254342
- Acronym / sponsor ID
- 28162
- Conditions
- Major Depressive Disorder, Major Depressive Episode, Major Depressive Disorder, Recurrent, Major Depression Mild, Major Depression Moderate, Major Depression Severe
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to obtain a reliable MRS signal
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 6 Aug 2013 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major depressive disorder | – | –There is no intervention/treatment in this study. |
| Non-depressed individuals | – | –There is no intervention/treatment in this study. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatry clinic; local community.
Key inclusion criteria (9 listed)
- 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
- Between 21 - 75 years of age.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Unable to obtain a reliable MRS signal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: Yes. Currently there is no plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Major Depressive Episode, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to obtain a reliable MRS signal). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations. (time frame: Within 7 Days following MRS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021; AzTrials last refreshed its copy on 26 Oct 2026.