Major Depressive DisorderPhase 4NCT00464711
Brain GABA Levels and Treatment Response in Major Depressive Disorder
A Phase 4 study testing Escitalopram in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2009
- Phase
- Phase 4
- 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
- Meet diagnostic criteria for current Major Depressive Disorder
- Men or women aged 18-65
- Medication-free for one week prior to the start of the study
- Agrees to use an effective form of contraception throughout the study
Who cannot join
- Anyone who is suicidal
- Pregnant or breastfeeding women
- Anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- Anyone with a history of seizure disorder or hypothyroidism
- Anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months)
- Anyone with a history of intolerance or multiple adverse drug reactions or allergy to (es)citalopram.
- Patients who are currently taking medications active on GABA, including benzodiazepines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.
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.
The purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers. Specifically, we want to see if symptoms of depression are related to a decrease in a brain chemical called GABA. We measure the concentration of GABA using a brain-scanning device called "magnetic resonance spectroscopy" (or "MRS"), which is a type of MRI.
The study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston. The first visit is the screening visit, which can last up to 3 hours. The rest of the visits are about a half hour long and take place every other week. In addition to these 8 visits, there are also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans. The first scan takes place within a few days after the screening visit, and the second scan will be at the end of the 14 weeks. Each scan visit lasts between an hour and a half and two hours. Subjects are reimbursed $50 per MRS scan and $25 per visit to McLean to cover travel costs.
All subjects in this study will receive escitalopram (or Lexapro), which is an antidepressant medication approved by the Food and Drug Administration. Subjects start at 10 mg daily of the escitalopram, but may be increased up to 30 mg if the study doctor thinks it is appropriate.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram
- 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.
EscitalopramDrug
Also called Lexapro
Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Other | single arm Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores
The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as > 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score < 8.
40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2009
- Study completionSep 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mclean Hospital
- Responsible party
- Principal investigator, David Mischoulon, MD, Massachusetts General Hospital
- Investigators
- Dan Iosifescu, MD, Principal investigator, Depression Clinical and Research Program, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464711
- Sponsor's protocol ID
- 2006-P-001295
- Status last verified
- Nov 2016
- First submitted
- 23 Apr 2007
- Last updated
- 4 Jan 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 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain GABA Levels and Treatment Response in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00464711
- Acronym / sponsor ID
- 2006-P-001295
- Conditions
- Major Depressive Disorder
- Keywords
- depression, biology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mclean Hospital
- Study start
- Sep 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Apr 2007 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.
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.
The purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers. Specifically, we want to see if symptoms of depression are related to a decrease in a brain chemical called GABA. We measure the concentration of GABA using a brain-scanning device called "magnetic resonance spectroscopy" (or "MRS"), which is a type of MRI.
The study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston. The first visit is the screening visit, which can last up to 3 hours. The rest of the visits are about a half hour long and take place every other week. In addition to these 8 visits, there are also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans. The first scan takes place within a few days after the screening visit, and the second scan will be at the end of the 14 weeks. Each scan visit lasts between an hour and a half and two hours. Subjects are reimbursed $50 per MRS scan and $25 per visit to McLean to cover travel costs.
All subjects in this study will receive escitalopram (or Lexapro), which is an antidepressant medication approved by the Food and Drug Administration. Subjects start at 10 mg daily of the escitalopram, but may be increased up to 30 mg if the study doctor thinks it is appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Other | Drug: Escitalopramsingle arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet diagnostic criteria for current Major Depressive Disorder
- Men or women aged 18-65
- Medication-free for one week prior to the start of the study
- Agrees to use an effective form of contraception throughout the study
Key exclusion criteria (7 listed)
- Anyone who is suicidal
- Pregnant or breastfeeding women
- Anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- Anyone with a history of seizure disorder or hypothyroidism
- Anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months)
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 |
|---|---|---|
| EscitalopramAlso: LexaproDose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study. | Drug | Escitalopram |
Primary outcome
Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores
Time frame: 12 weeks
The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as > 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score < 8. 40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Massachusetts General Hospital Depression Clinical and Research Program WebsiteLink provided by the sponsor.
- 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.
Dan Iosifescu, MD principal investigator
Depression Clinical and Research Program, Massachusetts General Hospital
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 Escitalopram in people with Major Depressive Disorder, run by Massachusetts General Hospital 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 4 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: finished, as of the sponsor's last update on 4 Jan 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?
Yes. Results are posted in the registry (first posted 4 Jan 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?
Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores (time frame: 12 weeks). 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 4 Jan 2017.