Major Depression in RemissionNCT04325529
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation)
An observational study of Major Depression in Remission, run by Mclean Hospital at 1 site in United States.
Trial summary
This study investigates how remitted individuals with past major depressive disorder (MDD) make approach-avoidance decisions and which brain regions are implicated in such decisions. Information collected through MRI and behavioral tasks will be used to predict depressive symptoms in the future. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression in Remission
- What is being tested?
- Aversive stimuli
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The subjects for this research will be 96 participants recruited from the community by the Center for Depression, Anxiety and Stress Research (Director: Dr. Diego Pizzagalli, Ph.D.). Participants will include: (1) 48 participants with past MDD; and (2) 48 demographically matched healthy controls.
Who may be able to join
- All genders, races, and ethnic origins, aged between 18 and 45
- Capable of providing written informed consent, and fluent in English
- Right-handed
- Absence of any psychotropic medications for at least 2 weeks
- Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)
- Meets inclusion criteria for all subjects, plus:
- History of MDD as defined by DSM-5
- Absence of anxiety disorder for the past two months
Who cannot join
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, or partner with vasectomy)
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- History of seizure disorder
- History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups
- History of substance use disorder or alcohol use disorder (as these terms are defined by DSM-5); except depressed subjects may have a history of 'Mild' substance/alcohol use disorder only if it ended as least 12 months ago
Show all 15Show fewer
- History of cocaine or stimulant use or dopaminergic drugs
- History or current diagnosis of dementia, or a score of < 26 on the Mini Mental State Examination at the screening visit;
- Patients with mood congruent or mood incongruent psychotic features
- Current use of other psychotropic drugs
- Clinical or laboratory evidence of hypothyroidism
- Patients with a lifetime history of electroconvulsive therapy (ECT)
- Failure to meet standard MRI safety requirements
- Abnormal ECG and lab results
- History of seizure disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Treatment Targets For Affective Disorders Through Cross-Species Investigation of Approach/Avoidance Decision Making
This study investigates how remitted individuals with past major depressive disorder (MDD) make approach-avoidance decisions and which brain regions are implicated in such decisions. Information collected through MRI and behavioral tasks will be used to predict depressive symptoms in the future.
Read the detailed description
The overarching goals of this research are to investigate: (1) neural substrates of approach/avoidance behaviors in remitted MDDs; (2) stress-induced signaling in remitted individuals with past MDD; (3) neural markers that prospectively predict disease course.
This will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach/avoidance decision-making task.
- Conditions
- Major Depression in Remission
- Being tested
- Aversive stimuli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aversive stimuliDevice
Also called no other name
Electrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013).
| Study group | Role | What they receive |
|---|---|---|
| remitted MDD | Unmedicated Remitted Participants with Past History of MDD Receives: Device: Aversive stimuli | |
| Control subjects | healthy control subjects Receives: Device: Aversive stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Interview
For assessing psychological state
Measured: Baseline
Behavioral Performance on the Probabilistic Reward Task (PRT)
The Probablilistic Reward Task assesses positive reinforcement learning.
Measured: Baseline
MRI Data
For testing the neural correlates of approach-avoidance decision making behaviors in a trans-diagnostic sample
Measured: MRI scans take place within 30 days of Screening Visit
Salivary Cortisol
For assessing stress level
Measured: Baseline
Follow-up Clinical interviews
To assess psychological state changes
Measured: Change from Baseline at 6 months and 12 months after the MRI scanning visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start19 Jan 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression in RemissionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Pizzagalli, Mclean Hospital
- Investigators
- Diego Pizzagalli, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325529
- Sponsor's protocol ID
- 2020A000886
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2020
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatment Targets For Affective Disorders Through Cross-Species Investigation of Approach/Avoidance Decision Making
- ClinicalTrials.gov ID
- NCT04325529
- Acronym / sponsor ID
- 2020A000886
- Conditions
- Major Depression in Remission
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Mar 2020 (actual)
- 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 study investigates how remitted individuals with past major depressive disorder (MDD) make approach-avoidance decisions and which brain regions are implicated in such decisions. Information collected through MRI and behavioral tasks will be used to predict depressive symptoms in the future.
Detailed description
The overarching goals of this research are to investigate: (1) neural substrates of approach/avoidance behaviors in remitted MDDs; (2) stress-induced signaling in remitted individuals with past MDD; (3) neural markers that prospectively predict disease course.
This will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach/avoidance decision-making task.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remitted MDD | – | Device: Aversive stimuliUnmedicated Remitted Participants with Past History of MDD |
| Control subjects | – | Device: Aversive stimulihealthy control subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The subjects for this research will be 96 participants recruited from the community by the Center for Depression, Anxiety and Stress Research (Director: Dr. Diego Pizzagalli, Ph.D.). Participants will include: (1) 48 participants with past MDD; and (2) 48 demographically matched healthy controls.
Key inclusion criteria (8 listed)
- All genders, races, and ethnic origins, aged between 18 and 45
- Capable of providing written informed consent, and fluent in English
- Right-handed
- Absence of any psychotropic medications for at least 2 weeks
- Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)
Key exclusion criteria (15 listed)
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, or partner with vasectomy)
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- History of seizure disorder
- History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups
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 |
|---|---|---|
| Aversive stimuliAlso: no other nameElectrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013). | Device | Control subjects, remitted MDD |
Primary outcome
Clinical Interview
Time frame: Baseline
For assessing psychological state
Behavioral Performance on the Probabilistic Reward Task (PRT)
Time frame: Baseline
The Probablilistic Reward Task assesses positive reinforcement learning.
MRI Data
Time frame: MRI scans take place within 30 days of Screening Visit
For testing the neural correlates of approach-avoidance decision making behaviors in a trans-diagnostic sample
Salivary Cortisol
Time frame: Baseline
For assessing stress level
Follow-up Clinical interviews
Time frame: Change from Baseline at 6 months and 12 months after the MRI scanning visit
To assess psychological state changes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Diego Pizzagalli, PhD principal investigator
Mclean Hospital
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 Major Depression in Remission, 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 8 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Interview (time frame: Baseline). The study lists 5 primary outcomes in all. 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 2 Nov 2026.