DepressionNCT00896441
Functional MRI Before and After Treatment for Depression
A study testing Citalopram in people with Depression and Mood Disorders, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to help us understand how depression changes brain activity and how this relates to mood, anxiety, and cognitive functions like memory. We also hope to develop a brain imaging test that will predict either before or within two weeks of starting a medicine whether the treatment will work. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Mood Disorders, Depressive Disorder
- What is being tested?
- Citalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be aged 18-65, have no significant neurologic history, must meet DSM-IV criteria for a diagnosis of major depression and be free of antidepressant or other psychotropic medication for a minimum of two weeks before enrollment. If a subject is talking psychiatric medication he/she may be weaned off of the medication by their treating physician prior to study enrollment. Such a course of action would only be advised if the current medication was not considered to be of any benefit to the subject. In particular, if a patient is on antidepressant medication which is of benefit, we would not advise tapering off medication -- and subsequent risk of relapse -- in order to participate in the study. The same line of thinking applies to all psychiatric diagnoses and associated medications candidate subjects may be taking.
Who cannot join
- Significant head trauma with loss of consciousness.
- Active abuse of alcohol or illegal substances.
- Excluded psychiatric diagnoses include: Bipolar Affective Disorder, primary psychotic disorders (Schizophrenia, Schizoaffective disorder), Obsessive-Compulsive Disorder
- Pregnant or nursing women.
- Any contraindication to being scanned in the 3T scanner at the Lucas Center such as having a pacemaker or any implanted device that has not been cleared for scanning at 3 Tesla.
- Any significant neurologic history (i.e. seizure, stroke, multiple sclerosis).
- Use of psychotropic medications within 2 weeks of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to help us understand how depression changes brain activity and how this relates to mood, anxiety, and cognitive functions like memory. We also hope to develop a brain imaging test that will predict either before or within two weeks of starting a medicine whether the treatment will work.
Read the detailed description
You were selected as a possible participant because you are suffering from a major depressive episode, and you have not previously tried the medication used in this study to treat depression. Approximately 60 subjects will participate in this study: 30 subjects who are currently suffering from a major depressive episode and 30 subjects who have never suffered from a major depressive episode.
If you choose to participate, you will be seen at the clinic for a total of five times plus three MRI scans. You will be seen once for a screening visit. If you choose to enroll, you will return a week later for the baseline visit and again at weeks 2, 4 and 8. Around the time of week one (baseline), week 2 and week 8 you will also undergo an MRI scan of the brain.
Screening Visit: The study physician and the research study staff will first screen you for eligibility. The screening visit includes meeting with a physician for a discussion of your medical history and current medications, taking your blood pressure, and checking your weight. Women of childbearing potential will also have a urine pregnancy test. You will meet with a member of the research staff for an interview to collect information about your depression and other psychiatric symptoms you have experienced. The purpose of the interview is to confirm your diagnosis and assess the current severity of your depression. The screening visit will take approximately 2 hours.
Week 1 (baseline): If you are eligible to continue with the study, you will return to the clinic within 7 days for a baseline visit. At your baseline visit, you will complete several tests to assess your memory and concentration. These tests are being conducted because problems with memory and concentration are common in people who are depressed and the researchers want to find out if there is a difference in your memory and concentration before and after taking the study medication. We also wish to compare the results to any findings from the brain imaging. Following the baseline visit, you will begin treatment with the antidepressant citalopram. The starting dose is 20 mg once per day.
Week 1 MRI: Around the time of your week one (baseline) visit and before starting medications, you will have your first MRI.
Week 2 visit: At the end of your second week, the study physician will meet with you to assess your overall condition. Your antidepressant medication will be counted to verify that you have been taking it as prescribed. Your dose will likely not change, but it is possible that it will be increased to as much as 40 mg. If you are experiencing side effects, your dose may be decreased. We will provide you with enough medication to last until your next visit.
Week 2 MRI: Around the time of your week 2 visit you will have your second MRI.
Week 4 visit: The study physician will meet with you to assess your overall condition. Your antidepressant medication will be counted to verify that you have been taking it as prescribed. The dose may be left unchanged, increased up to a total of 40 mg daily or decreased, if you are experiencing side effects (to a minimum of 20 mg daily). You will also be asked about any other medications you have taken since your last visit. We will provide you with enough medication to last until your next visit.
Week 6 (Telephone check-in): The study physician will check in with you by telephone to assess your overall condition. The dose of the citalopram may be left unchanged, increased to a maximum of 60 mg daily or decreased (to a minimum to 20 m daily) if you are experiencing side effects.
Week 8: (End-of-study visit) In addition to the usual visit procedures, the end-of-study visit will include repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of your depression. No study medication will be dispensed at this visit.
Week 8 MRI: Around the time of your week 8 visit you will have your third and final MRI.
- Conditions
- Depression, Mood Disorders, Depressive Disorder
- Being tested
- Citalopram
- Medical subject headings
- Depression, Mood Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Refer to Detailed Description Section for full description of intervention. Week 1 (baseline): Subject will complete several tests to assess the subject's memory and concentration. Following visit, they will begin treatment with the antidepressant citalopram.
Week 1 MRI: Subject will have their first MRI. Week 2 visit: Physician will meet with they to assess the subject's overall condition.
Week 2 MRI: Subject will have the subject's second MRI. Week 4 visit: The study physician will meet with the subject to assess their overall condition.
Week 6 (Telephone check-in): The study physician will check in with the subject by telephone to assess the subject's overall condition.
Week 8: (End-of-study visit) Subject will take repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of the subject's depression.
Week 8 MRI: Around the time of the subject's week 8 visit they will have the subject's third and final MRI.
| Study group | Role | What they receive |
|---|---|---|
| Depressed patients | Experimental | Depressed patients assigned in an open-label study of citalopram Receives: Drug: Citalopram |
| Controls | No intervention | Healthy controls used as a comparison (no intervention) group for change in resting-state fMRI over time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale Percent Change From Day 0 to D56
Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression
Measured: % change from baseline to Day 56 ( week 8)
Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex
The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.
Measured: baseline and week 8
Secondary outcomes (1)
Hamilton Anxiety Scale
Hamilton Anxiety Scale (HAMA) was utilized. Scores range from 0-56, with higher scores indicating more anxiety. The change score utilized baseline and Day 56 (week 8) scores. The change scores was HAMA day 1 less Ham A day 56 / HAMA Day 1. Thus, larger numbers equal a greater reduction in anxiety.
Measured: % change in anxiety from Day 1 to Day 56 (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2013
- Study completionJun 2014
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Keller, Stanford University
- Investigators
- Michael D Greicius, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896441
- Sponsor's protocol ID
- SU-04202009-2339
- Other IDs
- Stanford IRB #15305
- Status last verified
- Sep 2017
- First submitted
- 7 May 2009
- Last updated
- 13 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI Before and After Treatment for Depression
- ClinicalTrials.gov ID
- NCT00896441
- Acronym / sponsor ID
- SU-04202009-2339
- Conditions
- Depression, Mood Disorders, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 May 2009 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to help us understand how depression changes brain activity and how this relates to mood, anxiety, and cognitive functions like memory. We also hope to develop a brain imaging test that will predict either before or within two weeks of starting a medicine whether the treatment will work.
Detailed description
You were selected as a possible participant because you are suffering from a major depressive episode, and you have not previously tried the medication used in this study to treat depression. Approximately 60 subjects will participate in this study: 30 subjects who are currently suffering from a major depressive episode and 30 subjects who have never suffered from a major depressive episode.
If you choose to participate, you will be seen at the clinic for a total of five times plus three MRI scans. You will be seen once for a screening visit. If you choose to enroll, you will return a week later for the baseline visit and again at weeks 2, 4 and 8. Around the time of week one (baseline), week 2 and week 8 you will also undergo an MRI scan of the brain.
Screening Visit: The study physician and the research study staff will first screen you for eligibility. The screening visit includes meeting with a physician for a discussion of your medical history and current medications, taking your blood pressure, and checking your weight. Women of childbearing potential will also have a urine pregnancy test. You will meet with a member of the research staff for an interview to collect information about your depression and other psychiatric symptoms you have experienced. The purpose of the interview is to confirm your diagnosis and assess the current severity of your depression. The screening visit will take approximately 2 hours.
Week 1 (baseline): If you are eligible to continue with the study, you will return to the clinic within 7 days for a baseline visit. At your baseline visit, you will complete several tests to assess your memory and concentration. These tests are being conducted because problems with memory and concentration are common in people who are depressed and the researchers want to find out if there is a difference in your memory and concentration before and after taking the study medication. We also wish to compare the results to any findings from the brain imaging. Following the baseline visit, you will begin treatment with the antidepressant citalopram. The starting dose is 20 mg once per day.
Week 1 MRI: Around the time of your week one (baseline) visit and before starting medications, you will have your first MRI.
Week 2 visit: At the end of your second week, the study physician will meet with you to assess your overall condition. Your antidepressant medication will be counted to verify that you have been taking it as prescribed. Your dose will likely not change, but it is possible that it will be increased to as much as 40 mg. If you are experiencing side effects, your dose may be decreased. We will provide you with enough medication to last until your next visit.
Week 2 MRI: Around the time of your week 2 visit you will have your second MRI.
Week 4 visit: The study physician will meet with you to assess your overall condition. Your antidepressant medication will be counted to verify that you have been taking it as prescribed. The dose may be left unchanged, increased up to a total of 40 mg daily or decreased, if you are experiencing side effects (to a minimum of 20 mg daily). You will also be asked about any other medications you have taken since your last visit. We will provide you with enough medication to last until your next visit.
Week 6 (Telephone check-in): The study physician will check in with you by telephone to assess your overall condition. The dose of the citalopram may be left unchanged, increased to a maximum of 60 mg daily or decreased (to a minimum to 20 m daily) if you are experiencing side effects.
Week 8: (End-of-study visit) In addition to the usual visit procedures, the end-of-study visit will include repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of your depression. No study medication will be dispensed at this visit.
Week 8 MRI: Around the time of your week 8 visit you will have your third and final MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed patients | Experimental | Drug: CitalopramDepressed patients assigned in an open-label study of citalopram |
| Controls | No intervention | –Healthy controls used as a comparison (no intervention) group for change in resting-state fMRI over time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be aged 18-65, have no significant neurologic history, must meet DSM-IV criteria for a diagnosis of major depression and be free of antidepressant or other psychotropic medication for a minimum of two weeks before enrollment. If a subject is talking psychiatric medication he/she may be weaned off of the medication by their treating physician prior to study enrollment. Such a course of action would only be advised if the current medication was not considered to be of any benefit to the subject. In particular, if a patient is on antidepressant medication which is of benefit, we would not advise tapering off medication -- and subsequent risk of relapse -- in order to participate in the study. The same line of thinking applies to all psychiatric diagnoses and associated medications candidate subjects may be taking.
Key exclusion criteria (7 listed)
- Significant head trauma with loss of consciousness.
- Active abuse of alcohol or illegal substances.
- Excluded psychiatric diagnoses include: Bipolar Affective Disorder, primary psychotic disorders (Schizophrenia, Schizoaffective disorder), Obsessive-Compulsive Disorder
- Pregnant or nursing women.
- Any contraindication to being scanned in the 3T scanner at the Lucas Center such as having a pacemaker or any implanted device that has not been cleared for scanning at 3 Tesla.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramRefer to Detailed Description Section for full description of intervention. Week 1 (baseline): Subject will complete several tests to assess the subject's memory and concentration. Following visit, they will begin treatment with the antidepressant citalopram. Week 1 MRI: Subject will have their first MRI. Week 2 visit: Physician will meet with they to assess the subject's overall condition. Week 2 MRI: Subject will have the subject's second MRI. Week 4 visit: The study physician will meet with the subject to assess their overall condition. Week 6 (Telephone check-in): The study physician will check in with the subject by telephone to assess the subject's overall condition. Week 8: (End-of-study visit) Subject will take repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of the subject's depression. Week 8 MRI: Around the time of the subject's week 8 visit they will have the subject's third and final MRI. | Drug | Depressed patients |
Primary outcome
Hamilton Depression Rating Scale Percent Change From Day 0 to D56
Time frame: % change from baseline to Day 56 ( week 8)
Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression
Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex
Time frame: baseline and week 8
The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.
1 secondary outcome
Hamilton Anxiety Scale
Time frame: % change in anxiety from Day 1 to Day 56 (week 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael D Greicius principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citalopram in people with Depression and Mood Disorders, 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 1 inclusion and 7 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 13 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hamilton Depression Rating Scale Percent Change From Day 0 to D56 (time frame: % change from baseline to Day 56 ( week 8)). The study lists 2 primary outcomes in all. 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 13 Oct 2017; AzTrials last refreshed its copy on 31 Oct 2026.