Study of Neural Responses Induced by Antidepressant Effects (SONRISA)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Real-time Neurofeedback fMRI task pre- and post-RCT
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Neuroimaging biomarkers, MDD, Neurofeedback
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- WPIC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Antidepressant Treatment
Placebo
Arm Description
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
A placebo pill will be taken over an 8-week period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Neural Responses During the Sham Neurofeedback fMRI Task.
Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.
Full Information
NCT ID
NCT02674529
First Posted
January 22, 2016
Last Updated
October 11, 2022
Sponsor
Marta Peciña, MD PhD
1. Study Identification
Unique Protocol Identification Number
NCT02674529
Brief Title
Study of Neural Responses Induced by Antidepressant Effects
Acronym
SONRISA
Official Title
Study of Neural Responses Induced by Simulated Antidepressants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marta Peciña, MD PhD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Neuroimaging biomarkers, MDD, Neurofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antidepressant Treatment
Arm Type
Active Comparator
Arm Description
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo pill will be taken over an 8-week period.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Selective Serotonin Reuptake Inhibitor (SSRI)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Behavioral
Intervention Name(s)
Real-time Neurofeedback fMRI task pre- and post-RCT
Intervention Description
Placebo experiment during an fMRI scanning session
Primary Outcome Measure Information:
Title
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
Description
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
Secondary Outcome Measure Information:
Title
Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores
Description
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
Title
Neural Responses During the Sham Neurofeedback fMRI Task.
Description
Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Pecina, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
WPIC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Learn more about this trial
Study of Neural Responses Induced by Antidepressant Effects
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