Major Depressive DisorderPhase 2/3SONRISANCT02674529
Study of Neural Responses Induced by Antidepressant Effects
A Phase 2/3 study testing Escitalopram and Real-time Neurofeedback fMRI task pre- and post-RCT in people with Major Depressive Disorder, run by Marta Peciña, MD PhD at 1 site in United States.
Trial summary
The proposed work aims to examine the neural changes associated with fast-acting antidepressant treatments in order to develop imaging-based biomarkers of treatment response for depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram and Real-time Neurofeedback fMRI task pre- and post-RCT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to May 2021
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A man or woman age of 18 or older.
- Currently experiencing a depressive episode as part of Major Depressive Disorder.
- Able to tolerate lying still on your back for 60 minutes at a time.
- Have had no more than one failed antidepressant trial of adequate dose and duration.
- Have been antidepressant medication-free for at least 21 days prior to collection of imaging data (5 weeks for fluoxetine)
Who cannot join
- Are currently taking any psychiatric medication, or any potentially augmenting or sedative drugs.
- Have a history of inadequate response/tolerability to escitalopram; or history of resistant depression
- Pregnant or breastfeeding or plan to become pregnant over the duration of the study.
- Have a history (lifetime) of psychotic depressive, schizophrenic, bipolar, schizoaffective, or other Axis I psychotic disorders.
- Meet criteria for substance dependence in the last 6 months, except nicotine, or substance abuse in the last 2 months.
- Have a medical condition that contradicts treatment with escitalopram.
- Are currently receiving psychotherapy or any other treatment for your depression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Neural Responses Induced by Simulated Antidepressants
The proposed work aims to examine the neural changes associated with fast-acting antidepressant treatments in order to develop imaging-based biomarkers of treatment response for depression.
Read the detailed description
Over the past decade, neuroimaging tools have rapidly advanced the field of neural biomarkers of treatment response in depression. Still, despite obvious scientific progress in this field, the ability to implement neuroimaging biomarkers of antidepressant treatment response in clinical trial settings is lacking. In order to objectively assess the neural bases of treatment response in depression, the investigators will use a "Real-time Neurofeedback fMRI task", specifically designed to record and modulate mood improvement by providing neurofeedback in the context of the administration of an antidepressant treatment. In a pilot study, positive neurofeedback during the administration of the drug was associated with significant acute mood improvement and increased blood oxygen level dependent (BOLD) responses in the rostral anterior cingulate cortex (rACC), a common neural target of antidepressant treatments. The central hypothesis is that antidepressant effects in depression are mediated by increased neural activity in the rACC (AIM1), which can be used in clinical trials of antidepressant treatment to predict antidepressant effects (AIM 2) and assess the effect of antidepressant treatment on antidepressant-induced rACC neural responses (AIM 3). The results obtained from this project are expected to have an important impact on our ability to understand the cognitive and neural mechanisms implicated in antidepressant treatment responses in patients with depression, as well as on the ability to implement neuroimaging biomarkers of treatment response in the clinical trial settings.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram, Placebo, Real-time Neurofeedback fMRI task pre- and post-RCT
- Keywords
- Depression, Neuroimaging biomarkers, MDD, Neurofeedback
- 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
Selective Serotonin Reuptake Inhibitor (SSRI)
PlaceboDrug
Placebo
Real-time Neurofeedback fMRI task pre- and post-RCTBehavioural
Placebo experiment during an fMRI scanning session
| Study group | Role | What they receive |
|---|---|---|
| Antidepressant Treatment | Active comparator | 20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week. Receives: Drug: Escitalopram; Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT |
| Placebo | Placebo comparator | A placebo pill will be taken over an 8-week period. Receives: Drug: Placebo; Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was.[2] There is, however, a high degree of statistical correlation between scores on the two measures.
Measured: baseline and week 8
Secondary outcomes (2)
Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores
The Quick Inventory of Depressive Symptomatology (QIDS) is a 16-item, self-reported measure of depression that ranges from 1 (no depression) to 27 (very severe depression).
Measured: baseline and 8 weeks
Neural Responses During the Sham Neurofeedback fMRI Task.
Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2021
- Study completionMay 2021
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta Peciña, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marta Peciña, MD PhD, University of Pittsburgh
- Investigators
- Marta Pecina, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674529
- Sponsor's protocol ID
- STUDY19070392/PRO16050131
- Acronym
- SONRISA
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 2016
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The study will follow NIMH schedule for data sharing for clinical trials. The schedule allows for descriptive data to be submitted - but not shared - ongoing and results associated with a finding - both positive and negative - to be submitted prior to the communication of a result. Once a result is communicated, either through publication and/or on the NDCT website the data specifically defined to the clinical trial will then be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Neural Responses Induced by Simulated Antidepressants
- ClinicalTrials.gov ID
- NCT02674529
- Acronym / sponsor ID
- SONRISA / STUDY19070392/PRO16050131
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Neuroimaging biomarkers, MDD, Neurofeedback
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marta Peciña, MD PhDUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 3 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed work aims to examine the neural changes associated with fast-acting antidepressant treatments in order to develop imaging-based biomarkers of treatment response for depression.
Detailed description
Over the past decade, neuroimaging tools have rapidly advanced the field of neural biomarkers of treatment response in depression. Still, despite obvious scientific progress in this field, the ability to implement neuroimaging biomarkers of antidepressant treatment response in clinical trial settings is lacking. In order to objectively assess the neural bases of treatment response in depression, the investigators will use a "Real-time Neurofeedback fMRI task", specifically designed to record and modulate mood improvement by providing neurofeedback in the context of the administration of an antidepressant treatment. In a pilot study, positive neurofeedback during the administration of the drug was associated with significant acute mood improvement and increased blood oxygen level dependent (BOLD) responses in the rostral anterior cingulate cortex (rACC), a common neural target of antidepressant treatments. The central hypothesis is that antidepressant effects in depression are mediated by increased neural activity in the rACC (AIM1), which can be used in clinical trials of antidepressant treatment to predict antidepressant effects (AIM 2) and assess the effect of antidepressant treatment on antidepressant-induced rACC neural responses (AIM 3). The results obtained from this project are expected to have an important impact on our ability to understand the cognitive and neural mechanisms implicated in antidepressant treatment responses in patients with depression, as well as on the ability to implement neuroimaging biomarkers of treatment response in the clinical trial settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antidepressant Treatment | Active comparator | Drug: Escitalopram, Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week. |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCTA placebo pill will be taken over an 8-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A man or woman age of 18 or older.
- Currently experiencing a depressive episode as part of Major Depressive Disorder.
- Able to tolerate lying still on your back for 60 minutes at a time.
- Have had no more than one failed antidepressant trial of adequate dose and duration.
- Have been antidepressant medication-free for at least 21 days prior to collection of imaging data (5 weeks for fluoxetine)
Key exclusion criteria (7 listed)
- Are currently taking any psychiatric medication, or any potentially augmenting or sedative drugs.
- Have a history of inadequate response/tolerability to escitalopram; or history of resistant depression
- Pregnant or breastfeeding or plan to become pregnant over the duration of the study.
- Have a history (lifetime) of psychotic depressive, schizophrenic, bipolar, schizoaffective, or other Axis I psychotic disorders.
- Meet criteria for substance dependence in the last 6 months, except nicotine, or substance abuse in the last 2 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: LexaproSelective Serotonin Reuptake Inhibitor (SSRI) | Drug | Antidepressant Treatment |
| PlaceboPlacebo | Drug | Placebo |
| Real-time Neurofeedback fMRI task pre- and post-RCTPlacebo experiment during an fMRI scanning session | Behavioural | Antidepressant Treatment, Placebo |
Primary outcome
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
Time frame: baseline and week 8
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was.[2] There is, however, a high degree of statistical correlation between scores on the two measures.
2 secondary outcomes
Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores
Time frame: baseline and 8 weeks
Neural Responses During the Sham Neurofeedback fMRI Task.
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The study will follow NIMH schedule for data sharing for clinical trials. The schedule allows for descriptive data to be submitted - but not shared - ongoing and results associated with a finding - both positive and negative - to be submitted prior to the communication of a result. Once a result is communicated, either through publication and/or on the NDCT website the data specifically defined to the clinical trial will then be shared.
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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.
Marta Pecina, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Escitalopram and Real-time Neurofeedback fMRI task pre- and post-RCT in people with Major Depressive Disorder, run by Marta Peciña, MD PhD 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 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 3 Nov 2022. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 Nov 2022). 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?
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores (time frame: baseline and week 8). 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 3 Nov 2022.