A Phase 2/3 interventional study of Escitalopram and Placebo in Major Depressive Disorder, sponsored by Marta Peciña, MD PhD. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Marta Peciña, MD PhD · Phase 2/3, Interventional, and Treatment
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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Marta Peciña, MD PhD is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Drug: Escitalopram · Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT
A placebo pill will be taken over an 8-week period.
Drug: Placebo · Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT
Selective Serotonin Reuptake Inhibitor (SSRI)
Also known as: Lexapro
Placebo
Placebo experiment during an fMRI scanning session
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.
Time frame: baseline and week 8
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).
Time frame: 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.
Time frame: Baseline
| Milestone | Antidepressant Treatment | Placebo |
|---|---|---|
| Started | 25 | 29 |
| Completed | 22 | 24 |
| Not completed | 3 | 5 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| score on a scale | Changes in MADRS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm | Changes in MADRS Scores From Baseline to Week 8 Within the Placebo Arm |
|---|---|---|
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores | 11 ± 9 | 12 ± 9 |
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).
| score on a scale | Changes in QIDS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm | Changes in QIDS Scores From Baseline to Week 8 Within the Placebo Arm |
|---|---|---|
| Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores | 6.82 ± 6.01 | 5.54 ± 5.45 |
Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.
| BOLD signal change | Baseline fMRI Measures |
|---|---|
| Neural Responses During the Sham Neurofeedback fMRI Task. | 1.1 (0.47 to 1.61) |
Collected over Eight weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antidepressant Treatment | 0/25 (0%) | 0/25 (0%) | 22/25 (88%) |
| Placebo | 0/29 (0%) | 0/29 (0%) | 18/29 (62.1%) |
| Event | Antidepressant Treatment | Placebo |
|---|---|---|
| FatigueGeneral disorders | 12/25 | 5/29 |
| Appetite DisturbancesGastrointestinal disorders | 6/25 | 1/29 |
| NauseaGastrointestinal disorders | 6/25 | 3/29 |
| DizzinessNervous system disorders | 5/25 | 2/29 |
| InsomniaGeneral disorders | 3/25 | 5/29 |
| Gastrointestinal DiscomfortGastrointestinal disorders | 3/25 | 2/29 |
| HeadacheNervous system disorders | 3/25 | 2/29 |
| AnxietyNervous system disorders | 2/25 | 3/29 |
| Vivid Dreams/NightmaresNervous system disorders | 2/25 | 0/29 |
| Worsening of Depressive SymptomsNervous system disorders | 2/25 | 1/29 |
| Age, Categorical(Participants) | Antidepressant Treatment | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 29 | 54 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Antidepressant Treatment | Placebo | Total |
|---|---|---|---|
| Mean | 25.44 ± 6.33 | 23.45 ± 5.65 | 24.18 ± 5.76 |
| Sex: Female, Male(Participants) | Antidepressant Treatment | Placebo | Total |
|---|---|---|---|
| Female | 20 | 26 | 46 |
| Male | 5 | 3 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Antidepressant Treatment | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 23 | 29 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Antidepressant Treatment | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 6 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 8 | 10 |
| White | 14 | 15 | 29 |
| More than one race | 5 | 0 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Antidepressant Treatment | Placebo | Total |
|---|---|---|---|
| United States | 25 | 29 | 54 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Marta Peciña, MD PhD