DepressionPhase 4NCT00178828
Dynamic Measures of Neurochemistry in Mood Disorders
A Phase 4 study testing sertraline and bupropion in people with Depression, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- sertraline and bupropion
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Apr 2013
- Phase
- Phase 4
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- AGE RANGE: 18 to 50 years.
- WEIGHT: within 20% of ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical risks of poor access in overweight individuals, and because of physiologic risks in underweight individuals.
- SEX DISTRIBUTION: both men and women (self or partner surgically sterilized, or using double barrier method). To the extent possible, women will have CSF sampling at the same point in their menstrual cycles, ideally during the follicular phase.
- RACE: any
- HEALTH: healthy, ambulatory depressed or healthy adults; must show clear capacity to form consent based on a strong understanding of the potential risks and benefits.
Who cannot join
- Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities, history of deep venous thrombosis (DVT), thrombophlebitis, coagulopathy.
- Pregnancy.
- Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
- Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
- Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- Patients who have taken any unapproved prior or concomitant medications.
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- Patients who have donated blood within one month of the study.
- Patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings.
- Recent participation in other studies.
- Patients with histories of migraine will be considered individually, and warned of the risk of headache following spinal tap.
- Patients who smoke regularly, would experience withdrawal while hospitalized for 5 days, or who cannot abstain from tobacco for the entire duration of the study.
- Patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.
Read the detailed description
The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.
- Conditions
- Depression
- Being tested
- sertraline, bupropion
- Keywords
- Depression, antidepressant, SSRI
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
bupropionDrug
Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
What is being measured
The primary outcome is the main question the study is designed to answer.
Power spectral density (PSD) of monoamine metabolite measures
Power spectral density measures the rhythmicity, or periodicity, of the time series of monoamine metabolites.
Measured: Before antidepressant treatment and after 4 weeks of antidepressant treatment (during week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald M Salomon, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178828
- Sponsor's protocol ID
- 000373
- Other IDs
- 5K23MH001828-03
- Status last verified
- Apr 2017
- First submitted
- 12 Sep 2005
- Last updated
- 11 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Measures of Neurochemistry in Mood Disorders
- ClinicalTrials.gov ID
- NCT00178828
- Acronym / sponsor ID
- 000373
- Conditions
- Depression
- Keywords
- Depression, antidepressant, SSRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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.
The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.
Detailed description
The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- AGE RANGE: 18 to 50 years.
- WEIGHT: within 20% of ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical risks of poor access in overweight individuals, and because of physiologic risks in underweight individuals.
- SEX DISTRIBUTION: both men and women (self or partner surgically sterilized, or using double barrier method). To the extent possible, women will have CSF sampling at the same point in their menstrual cycles, ideally during the follicular phase.
- RACE: any
- HEALTH: healthy, ambulatory depressed or healthy adults; must show clear capacity to form consent based on a strong understanding of the potential risks and benefits.
Key exclusion criteria (12 listed)
- Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities, history of deep venous thrombosis (DVT), thrombophlebitis, coagulopathy.
- Pregnancy.
- Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
- Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
- Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
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 |
|---|---|---|
| sertralinePatients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5). | Drug | – |
| bupropionPatients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5). | Drug | – |
Primary outcome
Power spectral density (PSD) of monoamine metabolite measures
Time frame: Before antidepressant treatment and after 4 weeks of antidepressant treatment (during week 5)
Power spectral density measures the rhythmicity, or periodicity, of the time series of monoamine metabolites.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Ronald M Salomon, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline and bupropion in people with Depression, run by Vanderbilt University Medical Center 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 11 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Power spectral density (PSD) of monoamine metabolite measures (time frame: Before antidepressant treatment and after 4 weeks of antidepressant treatment (during week 5)). 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 11 Apr 2017.