Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4581 | mindfulness, emotion didactics, interpersonal skills, experiential learning Wiki | 0.45 |
| drug4734 | sham TMS Wiki | 0.45 |
| drug4806 | vitamin d Wiki | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3889 | TMS Wiki | 0.45 |
| drug529 | Behavioral Activation in real-life Wiki | 0.45 |
| drug2391 | Mindfulness exercises Wiki | 0.45 |
| drug4239 | Virtual Reality Behavioral Activation Wiki | 0.45 |
| drug4542 | it is a survey Wiki | 0.45 |
| drug4553 | liposomal lactoferrin Wiki | 0.45 |
| drug3554 | Self-System Therapy Wiki | 0.45 |
| drug4151 | Universal Screening Arm Wiki | 0.45 |
| drug2273 | MagPro X100 Stimulator, B70 Fluid-Cooled Coil Wiki | 0.32 |
Navigate: Correlations HPO
There are 5 clinical trials
Background: Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective. Objective: To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression. Eligibility: Adults ages 18-65 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks. Design: Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests. Phase 1 is 1-4 visits in 1 week. Participants will have: - Brain MRI. Participants will lie on a table in a scanner. - Questions about their medical history and psychology symptoms - Tests of mood and thinking - Tests of brain activity. Participants may do tasks during these tests: - A cone with magnetic detectors is put on the head. - A cap with electrodes is put on the scalp. - TMS. A brief electrical current passes through a wire coil on the scalp. - A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock. Phase 2 is about 6 to 7 weeks. - There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks. - Participants will receive rTMS and another therapy by computer. - For rTMS, repeated pulses will pass through the coil. - This is followed by up to 3 additional visits, when: - Participants will repeat Phase 1 tests - Participants will rate their depression symptoms. Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.
Description: change in magnitude of BOLD signal with fMRI bold signal from DLPFC
Measure: Change in magnitude of Bold signal Time: 6 weeks after initiating interventionDescription: Recordings of brain activity
Measure: Electrophysiological changes using MEG and EEG measures Time: 6 weeks after initiating interventionDescription: Clinical symptom scales from which we derive scores
Measure: Clinical Rating Scales: BSL, C-SSRS, CTQ, HAM-A, NIH-BFI, PANAS, RBANS, RRS, SHAPS, and TLEQ Time: Variable: some 6 weeks after initiating intervention; others weeklyThe primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.
Description: Universal 1) Adolescents with PHQ-9 score >10 (screen Sept-Mar of the school year) or who at any point in the year exhibit behavior concerning for MDD prompting a SAP triage request, 2) Adolescents identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one SAP recommendation. Prior Sept-Nov screening adjusted per school preference. Targeted 1) Adolescents with behavior concerning for MDD prompting a SAP triage request, 2) Adolescents identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one SAP recommendation Concern for MDD based on a primary or secondary potentially MDD related SAP "incoming referral reason" SAP triage is not diagnostic, so MDD identified based on recommendations for MDD related school or community services (e.g. mental health treatment services) HRSA funds mostly rural schools (anticipated N=4738; all rural but one school) and PCORI funds urban schools (anticipated N=7768)
Measure: MDD composite: Adolescents MDD screen positive by PHQ-9 (universal arm) or with concern for MDD prompting Student Assistance Program (SAP) triage request, identified with MDD by SAP, and who engage with at least one SAP recommended service or treatment Time: up to 9 monthsDescription: Universal screening arm: Adolescents who have a PHQ-9 score >10 (screening with the PHQ-9 is planned during the academic year, e.g. September to March) or who at any point in the school year exhibit behavior concerning for MDD which prompts self or collateral request for SAP triage. Targeted screening arm: Adolescents with behavior concerning for MDD which prompts self or collateral request for SAP triage at any point during the school year. Concern for MDD is based on a primary or secondary potentially MDD related SAP "incoming referral reason".
Measure: MDD screen positive/concern: Adolescents who screen positive for MDD either by PHQ-9 (universal screening arm only) or by concern for MDD prompting a request for SAP triage Time: up to 9 monthsDescription: Universal screening arm: Patient health questionnaire positive response to question #9 re: suicidal thoughts, which requires management by the state-mandated school crisis plan or student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district). Targeted screening arm: Student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district). Any student suicide attempts or completed suicides shared with the school district will also be included.
Measure: Suicidal Adolescent Time: up to 9 monthsDescription: Universal and targeted screening arms: Adolescents who are identified as having MDD based on triage by the school SAP team. As SAP triage is not diagnostic, MDD identified will be based on SAP recommendations for school or community services which are MDD related (e.g. mental health treatment services).
Measure: MDD identification: Adolescents who are identified as having MDD based on triage by the school SAP team Time: up to 9 monthsDescription: Universal and targeted screening arms: Adolescents who successfully engage with at least one SAP recommendation. This may be fulfilled by parental report that an appointment was successfully scheduled.
Measure: MDD treatment engagement: Successful engagement with at least one SAP recommendation Time: up to 9 monthsDescription: This performance measure represents the percentage of all students scoring Proficient or Advanced on the Mathematics Algebra I Keystone Exam. Algebra I Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.
Measure: Standardized test scores: Keystone exams mathematics (school district). This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing. Time: up to 9 monthsDescription: This performance measure represents the percentage of all students scoring Proficient or Advanced on the ELA/Literature Keystone Exam. Literature Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.
Measure: Standardized test scores: Keystone exams English language arts (ELA; school district) This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing. Time: up to 9 monthsDescription: This performance measure represents the percentage of all students scoring Proficient or Advanced on the Science/Biology Keystone Exam. Biology Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.
Measure: Standardized test scores: Keystone exams science (school district) This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing. Time: up to 9 monthsDescription: This performance measure represents the percent of 12th grade students who have taken the PSAT or Plan at any time over the course of their educational experience.
Measure: Preliminary Scholastic Aptitude Test (PSAT)/Plan (school district) This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing. Time: up to 9 monthsDescription: This performance measure represents the percent of 12th grade students meeting both SAT College and Career Readiness benchmarks and/or scoring 22 or higher on the ACT taken at any time over the course of their educational experience.
Measure: Scholastic Aptitude Test (SAT)/ American College Testing (ACT) performance (school district) This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing. Time: up to 9 monthsDescription: data aggregate by grade level only schools currently track the number of student policy violations (e.g. for drug and alcohol, violence) and student suspensions
Measure: Student school policy violations and suspensions based on school district data Time: up to 9 monthsDescription: data aggregate by grade level only
Measure: Missed school days Time: up to 9 monthsDescription: data aggregate by grade level only
Measure: Grade point average Time: up to 9 monthsDescription: data aggregate by grade level only
Measure: Grade advancement: This measure represents the percent of students promoted in each grade for the school (grades 9-11, school district data) Time: up to 9 monthsDescription: data aggregate by grade level only
Measure: Graduation: This measure represents the percent of students who graduate 12th grade with a high school diploma (school district data) Time: up to 9 monthsDescription: Sex (Male, Female), Ethnicity, Race, Rural/Urban
Measure: Subgroup analyses based on school district demographic data Time: up to 9 monthsThe primary purpose of this study is to test the safety and feasibility of virtual reality (VR) technology in the use of behavioral activation (BA) as a treatment for major depressive disorder (MDD). The secondary purpose of this study is to examine whether any evidence of clinical efficacy exists for VR delivered BA.
Description: This outcome will be measured using the "Intention to use Technology " questions of the Technology Acceptance Model questionnaire. These are questions 11, 12, and 13 and allow participants the option of circling Strongly Disagree, Disagree, Neutral, Agree, or Strongly Agree.
Measure: Participant's desire to continue using VR after the study ends Time: 4-weeksDescription: Participant treatment dropout will be compared across each study arm.
Measure: Rates of dropout of VR-BA Time: 4-weeksDescription: This outcome will be measured using the "Attitudes Toward Use " questions of the Technology Acceptance Model questionnaire. These are questions 7, 8, 9, and 10 and allow participants the option of circling Strongly Disagree, Disagree, Neutral, Agree, or Strongly Agree.
Measure: Participant's satisfaction with the VR-BA treatment Time: 4-weeksDescription: This will be measured by noting the amount of times the VR headset is used.
Measure: Participant's use of the VR headset Time: 4-weeksDescription: This will be measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree, Disagree, Neutral, Agree, or Strongly Agree.
Measure: Participant's acceptance of VR-BA treatment Time: 4-weeksDescription: This will be determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual, Slightly more than usual, Moderately more than usual, or Severely more than usual.
Measure: How well can participants tolerate the VR-BA treatment? Time: 4-weeksDescription: This will be measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all, Slightly, Moderately, Strongly, or Very Strongly.
Measure: How present did individuals in the VR-BA treatment feel? Time: 4-weeks.Description: How participants' depression scores PHQ-9 change over time using VR-BA compared to BA in real life and a waitlist control. The PHQ-9 is a 9-question screener with a score range of 0-29, with 29 indicating the most severe depression and 0 indicating a lack of depression symptoms.
Measure: Clinical efficacy of using VR as a tool to deliver BA Time: 4-weeksThe current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Description: Less than or equal to 10
Measure: Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24) Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: changes in scores
Measure: Change in HRSD-24 Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: 50% Reduction in score
Measure: Response on HRSD-24 Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: Less than or equal to 4
Measure: Remission on Patient Health Questionnaire (PHQ-9) Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: 50% Reduction in score
Measure: Response on PHQ-9 Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: changes in scores
Measure: Change in PHQ-9 Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: Less than or equal to 4
Measure: Remission on General Anxiety Disorder 7 item (GAD-7) Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: 50% Reduction in score
Measure: Response on GAD-7 Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: changes in scores
Measure: Change in GAD-7 Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: Less than or equal to 12
Measure: Remission on Beck Depression Inventory (BDI-II) Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: 50% Reduction in Score
Measure: Response on BDI-II Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: changes in scores
Measure: Change on BDI-II Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: Score of 0
Measure: Remission on Beck Scale for Suicidal Ideation (SSI) Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: changes in scores
Measure: Change on SSI Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: changes in scores
Measure: Change in WHO Disability Assessment Schedule (WHODAS) Time: Up to 10 days (From screening/baseline to end of the acute treatment)Description: Includes number of treatment days needed and number going on to receive ECT
Measure: Proportion of Patients Maintaining Response During Relapse Prevention Time: 24 weeks (Tapering and Relapse prevention phase)This study aims to advance research on group sessions for mental health. The first-of-its-kind study measuring various features in a group setting, combining rich metadata in creating state-of-the-art machine learning models, and developing workflows for mental health that are both scalable and personalized.
Description: A repeated measures, within-subject design using exploratory techniques will identify the best group session features or combination of features that correlate with or predict change on the PHQ-9.
Measure: Patient Health Questionnaire (PHQ-9) Time: March 30, 2021Description: A repeated measures, within-subject design using exploratory techniques will identify the best group session features or combination of features that correlate with or predict change on the GAD-7.
Measure: Generalized Anxiety Disorder (GAD-7) Time: June 20, 2021Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports