DepressionNCT07397858
Cognition and Behavior With Sham Accelerated TMS
A study of Depression, run by University of California, Davis at 1 site in United States.
Trial summary
The goal of this clinical study is to understand how a person's expectations about treatment can influence their mood, motivation, and reactions to everyday rewards. The study includes young people ages 15-25 who will complete a sham (placebo) version of an accelerated transcranial magnetic stimulation (TMS)… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Depression
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2026to Jan 2028
- Phase
- Interventional
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking
- Able to provide informed consent (and assent if < 18 years)
- 15-25 years old
- Slight-to-severe symptoms of depression
Who cannot join
- Past exposure to Transcranial Magnetic Stimulation
- Unable to consent (due to medical condition, psychosis, substance use, etc)
- Acute suicidal crisis or with active medical illness that would interfere with participation
- Contraindications to receiving MRI as determined by screening questionnaires (Contraindications for MRI include metal in the body related to an injury or surgery, for example, surgical clips, metal fragments in the eyes, or piercings that cannot be removed. Subjects with braces or permanent retainers will not be scanned, because the effects on image signal are not well understood and may affect comparability between subjects and scan sites. Participants will be excluded for major neurological problems, such as seizure disorder, traumatic brain injury with loss of consciousness, or sensory problems that may impair task performance, such as blindness.)
- Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Maitri Khanna, 916-848-5135, makhanna@health.ucdavis.edu
About this study
Official title: Studies of Cognition and Behavior Using Sham Accelerated Transcranial Magnetic Stimulation
The goal of this clinical study is to understand how a person's expectations about treatment can influence their mood, motivation, and reactions to everyday rewards. The study includes young people ages 15-25 who will complete a sham (placebo) version of an accelerated transcranial magnetic stimulation (TMS) treatment. No active brain stimulation is given.
The main questions this study aims to answer are:
Read more
- Do expectancy and treatment beliefs change during and after an accelerated sham TMS schedule?
- Do these expectations influence mood, reward processing, or craving?
- Does a more intensive schedule of sham sessions lead to different expectancy effects than a slower, once-daily schedule?
Participants will:
- Complete baseline clinical assessments and an MRI session
- Undergo five days of accelerated sham TMS (no active brain stimulation is delivered)
- Complete post-treatment MRI and follow-up assessments at 1 week and 4 weeks
- Conditions
- Depression
- Being tested
- Transcranial Magnetic Stimulation Sham
- Keywords
- TMS, Sham TMS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation ShamDevice
All study participants will receive sham TMS (no active stimulation will be provided).
| Study group | Role | What they receive |
|---|---|---|
| Open label sham | Other | All study participants will receive sham TMS (no active stimulation will be provided). Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerated sham TMS feasibility
Proportion of participants who complete the accelerated sham TMS protocol, defined as completion of all scheduled stimulation sessions. Feasibility will be assessed using session attendance logs and protocol completion records.
Measured: From enrollment to end of study at 5 weeks
Change in treatment expectancy and beliefs
Change in treatment expectancy and beliefs score from baseline to end of study at 5 weeks, as measured by the Credibility/Expectancy Questionnaire (CEQ). Outcomes will be quantified as the difference in total CEQ score between time points. CEQ scores range from 1 to 9 for treatment credibility and expectancy, with higher scores indicating greater perceived credibility/ expectancy.
Measured: From enrollment to end of study at 5 weeks
Change in reward sensitivity
Change in reward sensitivity will be assessed as the difference in scores from baseline to 5-week follow-up on validated self-report measures, including the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), the Snaith-Hamilton Pleasure Scale (SHAPS), and the Temporal Experience of Pleasure Scale (TEPS). SPSRQ scores range from 0-24 for each subscale, TEPS scores range from 18-108, and SHAPS scores range from 14-56, with higher scores indicating greater sensitivity to reward/punishment, pleasure capacity, and anhedonia, respectively.
Measured: From enrollment to end of study at 5 weeks
Change in craving and engagement
Changes in cravings and engagement with reinforcing stimuli will be assessed as the difference in scores from baseline to 5-week follow-up on various self-report measures and tasks. Craving will be assessed using a behavioral craving task, with outcomes quantified as change in task-derived craving ratings or performance metrics from baseline to follow-up. Substance use will additionally be assessed as change in drug use frequency and quantity over the study period.
Measured: From enrollment to end of study at 5 weeks
Secondary outcomes (4)
Changes in depressive symptoms
Change in depressive symptoms will be measured as the difference in total score from baseline to 5-week follow-up on the Montgomery-Asberg Depression Rating Scale (MADRS). MADRS scores range from 0-60, with higher scores indicating greater depressive symptom severity.
Measured: From enrollment to end of study at 5 weeks
Changes in mania symptoms
Change in mania symptoms will be measured as the difference in total score from baseline to 5-week follow-up on the Young Mania Rating Scale (YMRS). YMRS scores range from 0-60, with higher scores indicating greater manic symptom severity.
Measured: From enrollment to end of study at 5 weeks
Changes in suicidality
Suicidality will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS), with changes evaluated based on trajectories and patterns of ideation and behavior responses from baseline to the 5-week follow-up. Higher response levels reflect greater suicidality symptom severity.
Measured: From enrollment to end of study at 5 weeks
Change in quality of life and functioning
Change from baseline in quality of life and functional outcomes, assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), a standardized self-report measure evaluating satisfaction and functioning across multiple life domains. Q-LES-Q-SF scores range from 14-70, with higher scores indicating greater quality of life and satisfaction.
Measured: From enrollment to end of study at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start11 Apr 2026
- Primary completionAug 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397858
- Sponsor's protocol ID
- 2375938
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary outcome measures will be shared in accordance with the Institutional Review Board, including demographic variables, symptom rating scale scores, treatment assignment indicators, and visit-level timepoint data. Direct identifiers will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Cognition and Behavior Using Sham Accelerated Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT07397858
- Acronym / sponsor ID
- 2375938
- Conditions
- Depression
- Keywords
- TMS, Sham TMS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Feb 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.
The goal of this clinical study is to understand how a person's expectations about treatment can influence their mood, motivation, and reactions to everyday rewards. The study includes young people ages 15-25 who will complete a sham (placebo) version of an accelerated transcranial magnetic stimulation (TMS) treatment. No active brain stimulation is given.
The main questions this study aims to answer are:
- Do expectancy and treatment beliefs change during and after an accelerated sham TMS schedule?
- Do these expectations influence mood, reward processing, or craving?
- Does a more intensive schedule of sham sessions lead to different expectancy effects than a slower, once-daily schedule?
Participants will:
- Complete baseline clinical assessments and an MRI session
- Undergo five days of accelerated sham TMS (no active brain stimulation is delivered)
- Complete post-treatment MRI and follow-up assessments at 1 week and 4 weeks
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label sham | Other | Device: Transcranial Magnetic Stimulation ShamAll study participants will receive sham TMS (no active stimulation will be provided). |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- English speaking
- Able to provide informed consent (and assent if < 18 years)
- 15-25 years old
- Slight-to-severe symptoms of depression
Key exclusion criteria (5 listed)
- Past exposure to Transcranial Magnetic Stimulation
- Unable to consent (due to medical condition, psychosis, substance use, etc)
- Acute suicidal crisis or with active medical illness that would interfere with participation
- Contraindications to receiving MRI as determined by screening questionnaires (Contraindications for MRI include metal in the body related to an injury or surgery, for example, surgical clips, metal fragments in the eyes, or piercings that cannot be removed. Subjects with braces or permanent retainers will not be scanned, because the effects on image signal are not well understood and may affect comparability between subjects and scan sites. Participants will be excluded for major neurological problems, such as seizure disorder, traumatic brain injury with loss of consciousness, or sensory problems that may impair task performance, such as blindness.)
- Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies
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 |
|---|---|---|
| Transcranial Magnetic Stimulation ShamAll study participants will receive sham TMS (no active stimulation will be provided). | Device | Open label sham |
Primary outcome
Accelerated sham TMS feasibility
Time frame: From enrollment to end of study at 5 weeks
Proportion of participants who complete the accelerated sham TMS protocol, defined as completion of all scheduled stimulation sessions. Feasibility will be assessed using session attendance logs and protocol completion records.
Change in treatment expectancy and beliefs
Time frame: From enrollment to end of study at 5 weeks
Change in treatment expectancy and beliefs score from baseline to end of study at 5 weeks, as measured by the Credibility/Expectancy Questionnaire (CEQ). Outcomes will be quantified as the difference in total CEQ score between time points. CEQ scores range from 1 to 9 for treatment credibility and expectancy, with higher scores indicating greater perceived credibility/ expectancy.
Change in reward sensitivity
Time frame: From enrollment to end of study at 5 weeks
Change in reward sensitivity will be assessed as the difference in scores from baseline to 5-week follow-up on validated self-report measures, including the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), the Snaith-Hamilton Pleasure Scale (SHAPS), and the Temporal Experience of Pleasure Scale (TEPS). SPSRQ scores range from 0-24 for each subscale, TEPS scores range from 18-108, and SHAPS scores range from 14-56, with higher scores indicating greater sensitivity to reward/punishment, pleasure capacity, and anhedonia, respectively.
Change in craving and engagement
Time frame: From enrollment to end of study at 5 weeks
Changes in cravings and engagement with reinforcing stimuli will be assessed as the difference in scores from baseline to 5-week follow-up on various self-report measures and tasks. Craving will be assessed using a behavioral craving task, with outcomes quantified as change in task-derived craving ratings or performance metrics from baseline to follow-up. Substance use will additionally be assessed as change in drug use frequency and quantity over the study period.
4 secondary outcomes
Changes in depressive symptoms
Time frame: From enrollment to end of study at 5 weeks
Changes in mania symptoms
Time frame: From enrollment to end of study at 5 weeks
Changes in suicidality
Time frame: From enrollment to end of study at 5 weeks
Change in quality of life and functioning
Time frame: From enrollment to end of study at 5 weeks
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 16 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcome measures will be shared in accordance with the Institutional Review Board, including demographic variables, symptom rating scale scores, treatment assignment indicators, and visit-level timepoint data. Direct identifiers will not 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Depression, run by University of California, Davis 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerated sham TMS feasibility (time frame: From enrollment to end of study at 5 weeks). The study lists 4 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 16 Jul 2026.