Treatment-Resistant DepressionNCT01598324
Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
An observational study of Treatment-Resistant Depression, run by Mclean Hospital at 1 site in United States.
Trial summary
This is an ancillary study to a clinical trial that is being conducted at Massachusetts General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-Resistant Depression
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in a clinical trial for treatment-resistant depression who agree to have magnetic resonance scans
Who may be able to join
- Aged 18-65
- Meets DSM-IV criteria for major depressive disorder
- Meets eligibility criteria for clinical trial of ziprasidone augmentation of escitalopram
- Capable of providing informed consent
Who cannot join
- Meets exclusion criteria for augmentation clinical trial protocol
- Pregnancy or unwillingness to avoid pregnancy during trial
- Current or past psychosis or bipolar disorder
- Substance abuse or dependence in the past six months
- Clinically significant suicidality
- Unstable cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizures
- Use of a concomitant medication that acts on glutamate or GABA neurotransmission
- Contraindication to magnetic resonance imaging (metal implant or device, occupational metal exposure, significant claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
McLean Hospital - McLean Imaging Center
Belmont, Massachusetts, 02478
About this study
This is an ancillary study to a clinical trial that is being conducted at Massachusetts General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399). This observational study will involve magnetic resonance scans to examine brain chemistry (neurotransmitter levels), brain activity, and functional connections between brain regions before and after participating in the trial. The neurotransmitters of interest are glutamate, glutamine, and GABA. Comparisons will be made between individuals who receive ziprasidone and individuals who receive an inactive placebo. Differences between participants who respond to standard antidepressants and those who require additional medication will also be examined. All participants will have a baseline magnetic resonance scan before starting medication. The second scan will be after 8 weeks of escitalopram treatment for those who respond or following 8 weeks of escitalopram plus ziaprasidone or placebo (16 weeks after starting) for those who do not respond to escitalopram alone. Participants will complete standard rating scales for depression at each visit.
- Conditions
- Treatment-Resistant Depression
- Keywords
- magnetic resonance imaging, magnetic resonance spectroscopy, depression, escitalopram, selective serotonin reuptake inhibitor, treatment-resistant depression, ziprasidone
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression
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 |
|---|---|---|
| escitalopram responders no augmentation | Participants who show a clinical response following 8 weeks on an SSRI will have a final magnetic resonance scan at the end of 8 weeks and will complete the study at that time. | |
| Ziprasidone augmentation | Participants who do not respond to escitalopram and are randomized to ziprasidone augmentation will have a final magnetic resonance scan following 8 weeks on ziprasidone. | |
| Placebo augmentation | Participants who do not respond to escitalopram and are randomized to placebo augmentation will have a final magnetic resonance scan following 8 weeks on placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutamate level in antidepressant non-responders
Glutamate levels are measured by magnetic resonance spectroscopy 8 weeks after starting treatment with ziprasidone or placebo in addition to escitalopram.
Measured: 8 weeks after starting combination therapy phase
Secondary outcomes (7)
Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment.
Measured: 8 weeks or 16 weeks
Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment
Measured: 8 weeks
GABA level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment
Measured: 8 weeks
Glutamine level in antidepressant non-responders
Glutamine levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone or placebo together with escitalopram.
Measured: 8 weeks
GABA level in antidepressant non-responders
GABA levels are measured by magnetic resonance spectroscopy 6 weeks after starting treatment with ziprasidone or placebo together with escitalopram.
Measured: 8 weeks
Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment
Functional connectivity will be measured by performing fMRI in the resting state.
Measured: 8 weeks after starting combination therapy phase
Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment and treatment-responders receiving an antidepressant
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 posted15 May 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013
Why it stopped: Clinical trial from which subjects were recruited closed to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-Resistant DepressionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Massachusetts General Hospital
- Responsible party
- Principal investigator, Tara Lauriat, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598324
- Sponsor's protocol ID
- WS2058787
- Status last verified
- Aug 2013
- First submitted
- 9 May 2012
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01598324
- Acronym / sponsor ID
- WS2058787
- Conditions
- Treatment-Resistant Depression
- Keywords
- magnetic resonance imaging, magnetic resonance spectroscopy, depression, escitalopram, selective serotonin reuptake inhibitor, treatment-resistant depression, ziprasidone
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Clinical trial from which subjects were recruited closed to enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Pfizer, Massachusetts General Hospital
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- First posted
- 15 May 2012 (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.
This is an ancillary study to a clinical trial that is being conducted at Massachusetts General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399). This observational study will involve magnetic resonance scans to examine brain chemistry (neurotransmitter levels), brain activity, and functional connections between brain regions before and after participating in the trial. The neurotransmitters of interest are glutamate, glutamine, and GABA. Comparisons will be made between individuals who receive ziprasidone and individuals who receive an inactive placebo. Differences between participants who respond to standard antidepressants and those who require additional medication will also be examined. All participants will have a baseline magnetic resonance scan before starting medication. The second scan will be after 8 weeks of escitalopram treatment for those who respond or following 8 weeks of escitalopram plus ziaprasidone or placebo (16 weeks after starting) for those who do not respond to escitalopram alone. Participants will complete standard rating scales for depression at each visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| escitalopram responders no augmentation | – | –Participants who show a clinical response following 8 weeks on an SSRI will have a final magnetic resonance scan at the end of 8 weeks and will complete the study at that time. |
| Ziprasidone augmentation | – | –Participants who do not respond to escitalopram and are randomized to ziprasidone augmentation will have a final magnetic resonance scan following 8 weeks on ziprasidone. |
| Placebo augmentation | – | –Participants who do not respond to escitalopram and are randomized to placebo augmentation will have a final magnetic resonance scan following 8 weeks on placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in a clinical trial for treatment-resistant depression who agree to have magnetic resonance scans
Key inclusion criteria (4 listed)
- Aged 18-65
- Meets DSM-IV criteria for major depressive disorder
- Meets eligibility criteria for clinical trial of ziprasidone augmentation of escitalopram
- Capable of providing informed consent
Key exclusion criteria (8 listed)
- Meets exclusion criteria for augmentation clinical trial protocol
- Pregnancy or unwillingness to avoid pregnancy during trial
- Current or past psychosis or bipolar disorder
- Substance abuse or dependence in the past six months
- Clinically significant suicidality
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
Glutamate level in antidepressant non-responders
Time frame: 8 weeks after starting combination therapy phase
Glutamate levels are measured by magnetic resonance spectroscopy 8 weeks after starting treatment with ziprasidone or placebo in addition to escitalopram.
7 secondary outcomes
Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment.
Time frame: 8 weeks or 16 weeks
Glutamine level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment
Time frame: 8 weeks
GABA level in treatment-responders following six weeks of antidepressant and non-responders following six weeks of adjunctive treatment
Time frame: 8 weeks
Glutamine level in antidepressant non-responders
Time frame: 8 weeks
GABA level in antidepressant non-responders
Time frame: 8 weeks
Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment
Time frame: 8 weeks after starting combination therapy phase
Functional connectivity in default mode network measured by functional magnetic resonance imaging (fMRI) in treatment-resistant individuals receiving adjunctive treatment and treatment-responders receiving an antidepressant
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Clinical trial from which subjects were recruited closed to enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
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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 Treatment-Resistant Depression, run by Mclean 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 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 13 Aug 2013. 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: Clinical trial from which subjects were recruited closed to enrollment). 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?
Glutamate level in antidepressant non-responders (time frame: 8 weeks after starting combination therapy phase). 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 Aug 2013.