CovidResearchTrials by Shray Alag


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Report for D003865: Depressive Disorder, Major NIH

(Synonyms: Depressive Disorder, M, Depressive Disorder, Ma, Depressive Disorder, Major)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug2600 Universal Screening Arm Wiki 0.58
drug2655 Virtual Reality Behavioral Activation Wiki 0.58
drug326 Behavioral Activation in real-life Wiki 0.58
drug1426 MagPro X100 Stimulator, B70 Fluid-Cooled Coil Wiki 0.41

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D003866 Depressive Disorder NIH 0.41
D003863 Depression, NIH 0.18

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0000716 Depressivity HPO 0.41

There are 3 clinical trials

Clinical Trials


1 Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

The 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.

NCT03716869 Major Depressive Disorder Major Depressive Episode Other: Universal Screening Arm
MeSH:Depressive Disorder Depression Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

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=3900; all rural but one school) and PCORI funds urban schools (anticipated N=13400

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 months

Secondary Outcomes

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: data aggregate by grade level only

Measure: Missed school days

Time: up to 9 months

Description: data aggregate by grade level only

Measure: Grade point average

Time: up to 9 months

Description: 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 months

Description: 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 months

Other Outcomes

Description: Sex (Male, Female), Ethnicity, Race, Rural/Urban

Measure: Subgroup analyses based on school district demographic data

Time: up to 9 months

2 Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

The 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.

NCT04268316 Major Depressive Disorder MDD Depres Depression Device: Virtual Reality Behavioral Activation Behavioral: Behavioral Activation in real-life
MeSH:Depression Depressive Disorder Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

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-weeks

Description: Participant treatment dropout will be compared across each study arm.

Measure: Rates of dropout of VR-BA

Time: 4-weeks

Description: 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-weeks

Description: 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-weeks

Description: 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-weeks

Description: 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-weeks

Description: 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.

Secondary Outcomes

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-weeks

3 A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic

The 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.

NCT04384965 Major Depressive Disorder Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil
MeSH:Depressive Disorder Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

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)

Secondary Outcomes

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)


HPO Nodes