Major Depressive DisorderPhase 4NCT01787240
Neurobiological Bases of Placebo Response in Major Depressive Disorder
A Phase 4 study testing Escitalopram 10mg in people with Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
We are doing this research study to find out if people who get better while taking a specific kind of antidepressant medication (a selective serotonin reuptake inhibitor, or SSRI) and people who get better while taking placebo (an inactive substance) have similar chemicals in their brains. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram 10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets diagnostic criteria for Major Depressive Disorder
- Written informed consent
- Men or women aged 18-60 years old
- A score of 18 or greater on the HAMD-28
- Patient must continue to meet criteria for current MDD at baseline. Patients must have Clinical Global Impression Improvement (CGI) scores ≥ 3 (i.e. minimally improved or less) from the screen to the baseline visit
- Agreeing to, and eligible for all procedures (only patients 18-45 will be eligible for MR-PET study)
Who cannot join
- Pregnant women or women of child bearing potential not using a medically accepted means of contraception
- Patients who are a serious suicide or homicide risk
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, uncontrolled seizure disorder
- The following DSM-IV diagnoses: a) organic mental disorders b) substance use disorders, including alcohol, active within the last year; c) schizophrenia; d) delusional disorder; e) psychotic disorders not elsewhere classified; f) bipolar disorder; g) acute bereavement; h) borderline or antisocial personality disorder i) current primary diagnoses of panic disorder, social phobia, GAD, or OCD (disorders that present as chief complaint and/or have their onset preceding the onset of MDD), l) Patients with mood congruent or mood incongruent psychotic features
- Currently taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressants, potential antidepressant augmenting agents (e.g., T3, SAMe, St. John's Wort, lithium, buspirone, Omega 3 fatty acids). If it is determined that it is safe to discontinue a medication, the patient will be required to wait a period equivalent to at least 5 half lives of the drug before the screening
- Patients who have taken an investigational psychotropic drug within the last year
Show all 13Show fewer
- Patients who have not responded to one or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g., for six weeks or more) over the past five years, as defined by the MGH-ATRQ
- History of inadequate response or poor tolerability to citalopram or escitalopram
- Any concomitant form of psychotherapy (depression-focused)
- Receiving or have received during the index episode Vagal nerve stimulation, ECT or rTMS, or other somatic antidepressant treatments
- Any reason not listed, determined by the site PI or study clinician, constituting good clinical practice and making participation in the study hazardous
- Contraindications to fMRI scanning and MR-PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
- MR-PET-specific exclusion criteria: Patients who are younger than 18 or older than 45 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Depression Clinical and Research Program
Boston, Massachusetts, 02114
About this study
We are doing this research study to find out if people who get better while taking a specific kind of antidepressant medication (a selective serotonin reuptake inhibitor, or SSRI) and people who get better while taking placebo (an inactive substance) have similar chemicals in their brains. Some participants may complete a procedure called Acute Tryptophan Depletion (ATD), which is a way to study the role of serotonin in depression. Some participants may also undergo a magnetic resonance-positron emission tomography (MR-PET) scan.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram 10mg, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram 10mgDrug
Also called Lexapro
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Receives: Drug: Placebo |
| Escitalopram 10mg | Experimental | After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Receives: Drug: Escitalopram 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).
Measured: This would occur at the first study visit (screening).
Secondary outcomes (2)
Effects of Acute Tryptophan Depletion on Mood
We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.
The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.
A negative change value refers to a decrease in HAM D score.
Measured: Baseline, Visit 10 (after 9 weeks in study)
Effects of Acute Tryptophan Depletion on Mood
We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.
The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.
A negative change value refers to a decrease in HAM D score.
Measured: Baseline, Visit 5 (4 weeks into study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Recruitment difficulties
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Cusin, MD, Massachusetts General Hospital
- Investigators
- Cristina Cusin, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787240
- Sponsor's protocol ID
- 2012P001241
- Status last verified
- Apr 2017
- First submitted
- 16 Jan 2013
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Bases of Placebo Response in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01787240
- Acronym / sponsor ID
- 2012P001241
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are doing this research study to find out if people who get better while taking a specific kind of antidepressant medication (a selective serotonin reuptake inhibitor, or SSRI) and people who get better while taking placebo (an inactive substance) have similar chemicals in their brains. Some participants may complete a procedure called Acute Tryptophan Depletion (ATD), which is a way to study the role of serotonin in depression. Some participants may also undergo a magnetic resonance-positron emission tomography (MR-PET) scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAfter a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. |
| Escitalopram 10mg | Experimental | Drug: Escitalopram 10mgAfter a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Meets diagnostic criteria for Major Depressive Disorder
- Written informed consent
- Men or women aged 18-60 years old
- A score of 18 or greater on the HAMD-28
- Patient must continue to meet criteria for current MDD at baseline. Patients must have Clinical Global Impression Improvement (CGI) scores ≥ 3 (i.e. minimally improved or less) from the screen to the baseline visit
Key exclusion criteria (13 listed)
- Pregnant women or women of child bearing potential not using a medically accepted means of contraception
- Patients who are a serious suicide or homicide risk
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, uncontrolled seizure disorder
- The following DSM-IV diagnoses: a) organic mental disorders b) substance use disorders, including alcohol, active within the last year; c) schizophrenia; d) delusional disorder; e) psychotic disorders not elsewhere classified; f) bipolar disorder; g) acute bereavement; h) borderline or antisocial personality disorder i) current primary diagnoses of panic disorder, social phobia, GAD, or OCD (disorders that present as chief complaint and/or have their onset preceding the onset of MDD), l) Patients with mood congruent or mood incongruent psychotic features
- Currently taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressants, potential antidepressant augmenting agents (e.g., T3, SAMe, St. John's Wort, lithium, buspirone, Omega 3 fatty acids). If it is determined that it is safe to discontinue a medication, the patient will be required to wait a period equivalent to at least 5 half lives of the drug before the screening
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 |
|---|---|---|
| Escitalopram 10mgAlso: Lexapro | Drug | Escitalopram 10mg |
| Placebo | Drug | Placebo |
Primary outcome
Feasibility
Time frame: This would occur at the first study visit (screening).
We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).
2 secondary outcomes
Effects of Acute Tryptophan Depletion on Mood
Time frame: Baseline, Visit 10 (after 9 weeks in study)
Effects of Acute Tryptophan Depletion on Mood
Time frame: Baseline, Visit 5 (4 weeks into study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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.
Cristina Cusin, M.D. principal investigator
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 10mg 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 6 inclusion and 13 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 16 May 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. Some participants in this study may receive a placebo. 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 14 Apr 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?
Feasibility (time frame: This would occur at the first study visit (screening).). 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 16 May 2017.