Depression Clinical Trial
Official title:
A Causal Neural Network-level Understanding of Depression and Its Treatment Through Concurrent TMS and fMRI
Verified date | March 2018 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overarching goal of this research program is to elucidate causal and directional neural
network- level abnormalities in depression, and how they are modulated by an
individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the
investigators can overcome a major limitation of neuroimaging - the inability to demonstrate
causality. The investigators' findings will serve as a platform for future studies wherein
TMS treatment can be directly guided by the investigators' ability to image and causally
manipulate specific neural networks.
Aim 1: To examine causal interactions between two major brain networks in depression.
Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in
depression.
Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls,
in two targeted and interacting networks, using concurrent transcranial magnetic stimulation
(TMS) and functional magnetic resonance imaging (fMRI).
Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in
normalization of baseline network-level deficits, and be predicted by degree of baseline
network abnormalities.
Status | Completed |
Enrollment | 85 |
Est. completion date | January 20, 2017 |
Est. primary completion date | January 20, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Men and women, ages 18 to 50 - Depression assessed through phone screen - Must comprehend English well to ensure adequate comprehension of the fMRI and TMS instructions, and of clinical scales - Has failed >1 previous adequate antidepressant medication trials - Right-handed - No current or history of neurological disorders - No seizure disorder or risk of seizures Exclusion Criteria: - Any contraindication to being scanned in the 3T scanners at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at the Lucas Center or CNI - Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc - Current rTMS treatment or prior treatment failure with rTMS - Current electroconvulsive therapy (ECT) or prior treatment failure with ECT - Currently pregnant or breastfeeding |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Institute of Mental Health (NIMH), The Dana Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | fMRI/TMS Assessed Neural Network Connectivity | From pre- to post-treatment, improvement will be based on enhanced functional connectivity. | Up to 3 months. | |
Other | Implicit Emotion Regulation | Implicit emotion regulation assessed through emotion conflict task performed during functional imaging. Performance based on reaction time and recruitment of emotion regulation regions during the task. | Up to 3 months | |
Other | fMRI-assessed Resting Connectivity | From pre- to post-treatment of patients with high-frequency repetitive TMS (rTMS) improvement shall be measured by normalization of baseline network-level deficits. | Up to 3 months. | |
Primary | Clinician Administered HAM-D | The Hamilton Depression Rating Scale (HAM-D) is a 24-item clinician-administered assessment utilized as a way of determining a patient's level of depression before, during, and after treatment. It takes approximately 15-20 minutes to complete the interview and score the results. Subscale scores are 0-2 (10 questions), 0-3 (2 questions), and 0-4 (12 questions). Subscales are totaled for an overall score (range 0 -76). For the overall score and all subscales, lower scores correspond to fewer symptoms, and higher scores correspond more symptoms. | Baseline; Day 10; Day 20 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |