DepressionPhase 2NOCICEPTNCT07868627
Novel and Conventional Interventions for Cognitive and Emotional Flexibility in Patient Trauma
A Phase 2 study testing D-Cycloserine (DCS), Transcranial Magnetic Stimulation and Unified Protocol in people with Depression and Anxiety, run by Mclean Hospital at 1 site in United States.
Trial summary
This study is testing whether combining a rapid form of transcranial magnetic stimulation (TMS), an oral medication called d-cycloserine (DCS), and therapy can improve brain flexibility and emotional control in adults experiencing moderate-to-severe depression, anxiety, or trauma symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Trauma Patients
- What is being tested?
- D-Cycloserine (DCS), Transcranial Magnetic Stimulation and Unified Protocol
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Mar 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Can safely receive TMS and study drugs
- Stable medication regimen for one month prior to study participation, and for the duration of the study
- Not currently receiving TMS, ECT, or ketamine
- No active safety concerns related to suicidality
- Moderate to severe Major Depressive Disorder as indicated by the Patient Health Questionnaire or Quick Inventory of Depressive Symptomatology
Who cannot join
- History of seizures or epilepsy
- History of intracranial pathology or lesions from any etiology
- History of traumatic brain injury including prolonged loss of consciousness more than 15 min
- Signs of increased intracranial pressure
- Any major neurological conditions (ex: recent stroke, tumor, neurodegenerative disorders, etc.)
- Major medical conditions that may cause a medical emergency in case of a - provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
Show all 10Show fewer
- Severe migraines that may result in treatment intolerance.
- Inability to tolerate MRI.
- Pregnancy
- Known allergy to D-cycloserine
Trial locations and contacts
1 site in 1 country.
About this study
This study is testing whether combining a rapid form of transcranial magnetic stimulation (TMS), an oral medication called d-cycloserine (DCS), and therapy can improve brain flexibility and emotional control in adults experiencing moderate-to-severe depression, anxiety, or trauma symptoms. TMS is a non-invasive treatment that uses gentle magnetic pulses to stimulate specific areas of the brain.
In this phase of the study, all participants receive active accelerated TMS (delivering multiple brief sessions in a single day) along with DCS, a medication that helps enhance brain learning and plasticity. Participants will be randomly assigned to have TMS directed at one of two brain targets: a region called the precuneus (identified using personalized brain scans) or the dorsolateral prefrontal cortex (a standard area for mood treatment). Afterward, participants are randomly assigned to complete three weeks of either therapist-led talk therapy (a modified Unified Protocol) or self-guided educational videos and readings. The main goals are to determine which brain stimulation target works best and to see whether therapist-led therapy leads to more lasting symptom relief and brain changes compared to self-guided education.
Read the detailed description
Trauma, severe stress, anxiety, and depression can make it difficult to adapt thinking patterns (cognitive flexibility) and manage intense, negative emotions (emotion regulation). While transcranial magnetic stimulation (TMS) and cognitive behavioral therapies are helpful, standard treatments can take weeks or months and do not work for everyone.
Researchers are combining three approaches to see if they can create stronger, longer-lasting benefits:
- Accelerated TMS (Ultra-aTMS): Delivering many short treatments in a single day rather than once daily over several weeks.
- D-cycloserine (DCS): A medication originally developed as an antibiotic that, at lower doses, helps brain cells form new connections and learn more effectively (neuroplasticity).
- Personalized Brain Circuit Targeting: Using functional MRI (fMRI) brain imaging to identify and target areas involved in emotional balance and thinking, particularly a central hub known as the precuneus.
- Targeted Skills Therapy: Providing a short course of the Unified Protocol (UP), a form of cognitive behavioral therapy designed to build emotion-regulation skills and mental flexibility.
- Conditions
- Depression, Anxiety, Trauma Patients
- Being tested
- D-Cycloserine (DCS), Transcranial Magnetic Stimulation, Unified Protocol, Psychoeducation
- Keywords
- mental health, tms, depression
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-Cycloserine (DCS)Drug
Single dose of 125 mg of D-cycloserine
Transcranial Magnetic StimulationDevice
TMS delivered to either the DLPFC or the precuneus
Unified ProtocolBehavioural
Cognitive Behavioral Therapy delivered in an abbreviated schedule by a licensed therapist
PsychoeducationBehavioural
Self-lead psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Precuneus + Unified Protocol | Experimental | TMS targeted to the precuneus followed by Unified Protocol (therapy) administered by a therapist Receives: Drug: D-Cycloserine (DCS); Device: Transcranial Magnetic Stimulation; Behavioral: Unified Protocol |
| Precuneus + Psychoeducation | Experimental | TMS targeted to the precuneus followed by self-led psychoeducation Receives: Drug: D-Cycloserine (DCS); Device: Transcranial Magnetic Stimulation; Behavioral: Psychoeducation |
| DLPFC + Unified Protocol | Experimental | TMS targeted to the DLPFC followed by Unified Protocol (therapy) administered by a therapist Receives: Drug: D-Cycloserine (DCS); Device: Transcranial Magnetic Stimulation; Behavioral: Unified Protocol |
| DLPFC + Psychoeducation | Experimental | TMS targeted to the DLPFC followed by self-led psychoeducation Receives: Drug: D-Cycloserine (DCS); Device: Transcranial Magnetic Stimulation; Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 test evaluates several factors that revolve around the criteria used to professionally diagnose depression under the current DSM-5. The total score is calculated and can range from zero to 27, with 27 being the highest and indicative of the worst outcome/severity.
A score of 20 or higher indicates that severe major depression Scoring between 15 and 19 suggests that there is possibly moderately severe major depression Scoring between 10 and 14 means that you may have a moderate severity depression A score between 5 and 9 reveals that mild symptoms of depression appear to exist
Measured: At each study visit, measured at Baseline, and 1-week, 1-month, and 3-months after treatment
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder - 7 Item Scale (GAD-7) is a self-administered questionnaire designed for screening and measuring the severity of generalized anxiety disorder (GAD). The GAD-7 consists of seven items that respondents rate based on their experiences over the past two weeks, with each item scored from 0 (not at all) to 3 (nearly every day). The cumulative score, ranging from 0 to 21, indicates the severity of GAD symptoms, with higher scores corresponding to greater anxiety levels. This simplicity in administration and interpretation makes the GAD-7 a practical tool for healthcare providers to quickly assess anxiety levels and monitor changes over time.
Measured: At each study visit, measured at baseline, 1-week, 1-month, and 3 months after treatment
Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated interview designed to assess the severity of depressive symptoms and detect change resulting from treatment. It consists of 10 items evaluating core symptoms of depression: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is rated on a 7-point scale ranging from 0 (symptom absent/normal) to 6 (severe/most abnormal). Individual item scores are summed to yield a total score ranging from 0 to 60. Higher total scores reflect greater depression severity (typically classified as 0-6: normal/absent; 7-19: mild; 20-34: moderate; 35-60: severe). Outcome values represent the change in total score from baseline, where negative change values indicate clinical improvement in depressive symptoms.
Measured: At each study visit, measured at baseline and 1-week, 1-month, and 3-months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua C. Brown, MD, PhD, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868627
- Sponsor's protocol ID
- 2023P002855
- Other IDs
- HR00112320037
- Acronym
- NOCICEPT
- Status last verified
- Jun 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Donald A. Vaughn, Brooke Marino, Alex Engelbertson, Aleksandra Dojnov, Lena Johnson, Madison Stine, Fidel Vila-Rodriguez, Nicholas Weiss, Georgine Nanos, Jonathan Downar, Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplasticity-Enhanced techniques in Depression (ONE-D): An open-label case series, Transcranial Magnetic Stimulation, Volume 5, 2025, 100200, ISSN 3050-5291, https://doi.org/10.1016/j.transm.2025.100200.
Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
PubMed 33243615
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel and Conventional Interventions for Cognitive and Emotional Flexibility in Patient Trauma
- ClinicalTrials.gov ID
- NCT07868627
- Acronym / sponsor ID
- NOCICEPT / 2023P002855
- Conditions
- Depression, Anxiety, Trauma Patients
- Keywords
- mental health, tms, depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 Oct 2026 (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 is testing whether combining a rapid form of transcranial magnetic stimulation (TMS), an oral medication called d-cycloserine (DCS), and therapy can improve brain flexibility and emotional control in adults experiencing moderate-to-severe depression, anxiety, or trauma symptoms. TMS is a non-invasive treatment that uses gentle magnetic pulses to stimulate specific areas of the brain.
In this phase of the study, all participants receive active accelerated TMS (delivering multiple brief sessions in a single day) along with DCS, a medication that helps enhance brain learning and plasticity. Participants will be randomly assigned to have TMS directed at one of two brain targets: a region called the precuneus (identified using personalized brain scans) or the dorsolateral prefrontal cortex (a standard area for mood treatment). Afterward, participants are randomly assigned to complete three weeks of either therapist-led talk therapy (a modified Unified Protocol) or self-guided educational videos and readings. The main goals are to determine which brain stimulation target works best and to see whether therapist-led therapy leads to more lasting symptom relief and brain changes compared to self-guided education.
Detailed description
Trauma, severe stress, anxiety, and depression can make it difficult to adapt thinking patterns (cognitive flexibility) and manage intense, negative emotions (emotion regulation). While transcranial magnetic stimulation (TMS) and cognitive behavioral therapies are helpful, standard treatments can take weeks or months and do not work for everyone.
Researchers are combining three approaches to see if they can create stronger, longer-lasting benefits:
- Accelerated TMS (Ultra-aTMS): Delivering many short treatments in a single day rather than once daily over several weeks.
- D-cycloserine (DCS): A medication originally developed as an antibiotic that, at lower doses, helps brain cells form new connections and learn more effectively (neuroplasticity).
- Personalized Brain Circuit Targeting: Using functional MRI (fMRI) brain imaging to identify and target areas involved in emotional balance and thinking, particularly a central hub known as the precuneus.
- Targeted Skills Therapy: Providing a short course of the Unified Protocol (UP), a form of cognitive behavioral therapy designed to build emotion-regulation skills and mental flexibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Precuneus + Unified Protocol | Experimental | Drug: D-Cycloserine (DCS), Device: Transcranial Magnetic Stimulation, Behavioral: Unified ProtocolTMS targeted to the precuneus followed by Unified Protocol (therapy) administered by a therapist |
| Precuneus + Psychoeducation | Experimental | Drug: D-Cycloserine (DCS), Device: Transcranial Magnetic Stimulation, Behavioral: PsychoeducationTMS targeted to the precuneus followed by self-led psychoeducation |
| DLPFC + Unified Protocol | Experimental | Drug: D-Cycloserine (DCS), Device: Transcranial Magnetic Stimulation, Behavioral: Unified ProtocolTMS targeted to the DLPFC followed by Unified Protocol (therapy) administered by a therapist |
| DLPFC + Psychoeducation | Experimental | Drug: D-Cycloserine (DCS), Device: Transcranial Magnetic Stimulation, Behavioral: PsychoeducationTMS targeted to the DLPFC followed by self-led psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Can safely receive TMS and study drugs
- Stable medication regimen for one month prior to study participation, and for the duration of the study
- Not currently receiving TMS, ECT, or ketamine
- No active safety concerns related to suicidality
- Moderate to severe Major Depressive Disorder as indicated by the Patient Health Questionnaire or Quick Inventory of Depressive Symptomatology
Key exclusion criteria (10 listed)
- History of seizures or epilepsy
- History of intracranial pathology or lesions from any etiology
- History of traumatic brain injury including prolonged loss of consciousness more than 15 min
- Signs of increased intracranial pressure
- Any major neurological conditions (ex: recent stroke, tumor, neurodegenerative disorders, etc.)
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 |
|---|---|---|
| D-Cycloserine (DCS)Single dose of 125 mg of D-cycloserine | Drug | DLPFC + Psychoeducation, DLPFC + Unified Protocol, Precuneus + Psychoeducation, Precuneus + Unified Protocol |
| Transcranial Magnetic StimulationTMS delivered to either the DLPFC or the precuneus | Device | DLPFC + Psychoeducation, DLPFC + Unified Protocol, Precuneus + Psychoeducation, Precuneus + Unified Protocol |
| Unified ProtocolCognitive Behavioral Therapy delivered in an abbreviated schedule by a licensed therapist | Behavioural | DLPFC + Unified Protocol, Precuneus + Unified Protocol |
| PsychoeducationSelf-lead psychoeducation | Behavioural | DLPFC + Psychoeducation, Precuneus + Psychoeducation |
Primary outcome
Patient Health Questionnaire 9 (PHQ-9)
Time frame: At each study visit, measured at Baseline, and 1-week, 1-month, and 3-months after treatment
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 test evaluates several factors that revolve around the criteria used to professionally diagnose depression under the current DSM-5. The total score is calculated and can range from zero to 27, with 27 being the highest and indicative of the worst outcome/severity. A score of 20 or higher indicates that severe major depression Scoring between 15 and 19 suggests that there is possibly moderately severe major depression Scoring between 10 and 14 means that you may have a moderate severity depression A score between 5 and 9 reveals that mild symptoms of depression appear to exist
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: At each study visit, measured at baseline, 1-week, 1-month, and 3 months after treatment
The Generalized Anxiety Disorder - 7 Item Scale (GAD-7) is a self-administered questionnaire designed for screening and measuring the severity of generalized anxiety disorder (GAD). The GAD-7 consists of seven items that respondents rate based on their experiences over the past two weeks, with each item scored from 0 (not at all) to 3 (nearly every day). The cumulative score, ranging from 0 to 21, indicates the severity of GAD symptoms, with higher scores corresponding to greater anxiety levels. This simplicity in administration and interpretation makes the GAD-7 a practical tool for healthcare providers to quickly assess anxiety levels and monitor changes over time.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: At each study visit, measured at baseline and 1-week, 1-month, and 3-months after treatment
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated interview designed to assess the severity of depressive symptoms and detect change resulting from treatment. It consists of 10 items evaluating core symptoms of depression: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is rated on a 7-point scale ranging from 0 (symptom absent/normal) to 6 (severe/most abnormal). Individual item scores are summed to yield a total score ranging from 0 to 60. Higher total scores reflect greater depression severity (typically classified as 0-6: normal/absent; 7-19: mild; 20-34: moderate; 35-60: severe). Outcome values represent the change in total score from baseline, where negative change values indicate clinical improvement in depressive symptoms.
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 9 Oct 2026.
- BackgroundDonald A. Vaughn, Brooke Marino, Alex Engelbertson, Aleksandra Dojnov, Lena Johnson, Madison Stine, Fidel Vila-Rodriguez, Nicholas Weiss, Georgine Nanos, Jonathan Downar, Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplasticity-Enhanced techniques in Depression (ONE-D): An open-label case series, Transcranial Magnetic Stimulation, Volume 5, 2025, 100200, ISSN 3050-5291, https://doi.org/10.1016/j.transm.2025.100200.
- Background: PubMed 33243615Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-Cycloserine (DCS), Transcranial Magnetic Stimulation and Unified Protocol in people with Depression and Anxiety, 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 5 inclusion and 10 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 9 Oct 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient Health Questionnaire 9 (PHQ-9) (time frame: At each study visit, measured at Baseline, and 1-week, 1-month, and 3-months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07868627, which also lists 2 linked publications.
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 9 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.