Major Depressive DisorderPhase 3NCT00361218
Biological Markers of Response to Treatment in Major Depressive Disorder
A Phase 3 study testing open-label selective serotonin reuptake inhibitor (SSRI) in people with Major Depressive Disorder, run by Massachusetts General Hospital.
Trial summary
The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- open-label selective serotonin reuptake inhibitor (SSRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Dec 2008
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65
- Meet criteria for current Major Depressive Disorder
- Antidepressant medication-free for at least 2 weeks prior to the start of the study
Who cannot join
- Pregnant or breastfeeding women
- Anyone who is suicidal
- Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania
- Anyone currently taking an SSRI
- Past intolerance to Lexapro or Celexa
About this study
Official title: Serum Brain-Derived Neurotrophic Factor (BDNF) and QEEG as Biological Markers of Response to (Es)Citalopram Treatment in Major Depressive Disorder
The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).
Read the detailed description
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain.
It often takes several weeks to find out if an antidepressant medication is going to work for someone. This research study aims to identify tests that are able to predict if a medication will work, even before a person starts to feel better. The first test is a measurement of the blood protein Brain-Derived Neurotrophic Factor (BDNF), which is involved with brain cell growth. The second test is a Quantitative Electroencephalogram (QEEG), which measures brain activity.
The study lasts for 8 weeks and involves 5 total visits to the clinic. Throughout the study, all subjects will receive either escitalopram (Lexapro) or citalopram (Celexa) on the basis of the study doctor's clinical judgment. The dose of the medications can be increased at any point in time if the study doctor thinks it is appropriate. After the first screen visit (which lasts about 3 hours), each subsequent half-hour visit will involve a 2-tablespoon blood draw to measure BDNF levels, as well as a QEEG in which small, painless electrodes are stuck to the subject's forehead and electrical activity of the brain is measured. At the end of the 8 weeks, subjects are offered 3 months of free follow-up care, including medications.
- Conditions
- Major Depressive Disorder
- Being tested
- open-label selective serotonin reuptake inhibitor (SSRI)
- Keywords
- depression, biology
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open-label selective serotonin reuptake inhibitor (SSRI)Drug
Also called escitalopram or citalopram
Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.
| Study group | Role | What they receive |
|---|---|---|
| open-label selective serotonin reuptake inhibitor (SSRI) | Other | citalopram or escitalopram Receives: Drug: open-label selective serotonin reuptake inhibitor (SSRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Brain-derived Neurotrophic Factor (BDNF) Levels
"Pre-SSRI BDNF Level" refers to the data collection point before SSRI intake and "Post-SSRI BDNF Level" refers to the data collection point 8 weeks after SSRI intake.
Measured: 8 weeks
Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response
Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation.
Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionDec 2008
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 Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John W. Denninger, MD, PhD, Massachusetts General Hospital
- Investigators
- John Denninger, MD, PhD, Principal investigator, Depression Clinical and Research Program, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361218
- Sponsor's protocol ID
- 2005P000413
- Status last verified
- Apr 2018
- First submitted
- 4 Aug 2006
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Brain-Derived Neurotrophic Factor (BDNF) and QEEG as Biological Markers of Response to (Es)Citalopram Treatment in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00361218
- Acronym / sponsor ID
- 2005P000413
- Conditions
- Major Depressive Disorder
- Keywords
- depression, biology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Posted 26 Sep 2013
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 find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).
Detailed description
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain.
It often takes several weeks to find out if an antidepressant medication is going to work for someone. This research study aims to identify tests that are able to predict if a medication will work, even before a person starts to feel better. The first test is a measurement of the blood protein Brain-Derived Neurotrophic Factor (BDNF), which is involved with brain cell growth. The second test is a Quantitative Electroencephalogram (QEEG), which measures brain activity.
The study lasts for 8 weeks and involves 5 total visits to the clinic. Throughout the study, all subjects will receive either escitalopram (Lexapro) or citalopram (Celexa) on the basis of the study doctor's clinical judgment. The dose of the medications can be increased at any point in time if the study doctor thinks it is appropriate. After the first screen visit (which lasts about 3 hours), each subsequent half-hour visit will involve a 2-tablespoon blood draw to measure BDNF levels, as well as a QEEG in which small, painless electrodes are stuck to the subject's forehead and electrical activity of the brain is measured. At the end of the 8 weeks, subjects are offered 3 months of free follow-up care, including medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open-label selective serotonin reuptake inhibitor (SSRI) | Other | Drug: open-label selective serotonin reuptake inhibitor (SSRI)citalopram or escitalopram |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-65
- Meet criteria for current Major Depressive Disorder
- Antidepressant medication-free for at least 2 weeks prior to the start of the study
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Anyone who is suicidal
- Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania
- Anyone currently taking an SSRI
- Past intolerance to Lexapro or Celexa
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 |
|---|---|---|
| open-label selective serotonin reuptake inhibitor (SSRI)Also: escitalopram or citalopramDuration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion. | Drug | open-label selective serotonin reuptake inhibitor (SSRI) |
Primary outcome
Serum Brain-derived Neurotrophic Factor (BDNF) Levels
Time frame: 8 weeks
"Pre-SSRI BDNF Level" refers to the data collection point before SSRI intake and "Post-SSRI BDNF Level" refers to the data collection point 8 weeks after SSRI intake.
Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response
Time frame: 8 weeks
Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation. Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Massachusetts General Hospital Depression Clinical and Research Program WebsiteLink provided by the sponsor.
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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.
John Denninger, MD, PhD principal investigator
Depression Clinical and Research Program, Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing open-label selective serotonin reuptake inhibitor (SSRI) in people with Major Depressive Disorder, run by Massachusetts General Hospital.
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 3 inclusion and 5 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2013). 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?
Serum Brain-derived Neurotrophic Factor (BDNF) Levels (time frame: 8 weeks). 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 11 May 2018.