DepressionNCT03135756
Mechanisms of Anxiety and Depression Study
An observational study of Depression and Anxiety, run by Palo Alto University at 2 sites in United States.
Trial summary
Eligible participants will come in for three separate visits in which they will be interviewed, perform a variety of tasks, and undergo a non-invasive MRI scan. The investigators anticipate that (1) participants with anxiety and depression will likely perform differently than the healthy controls on cognitive tasks… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2015to 14 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The investigators expect to enroll 50 right-handed, English as first language, adults will be recruited from the community through various advertisements. The investigators expect that 25 will be healthy controls and 25 will be a clinical sample exhibiting clinically significant symptoms of anxiety and depression.
Who may be able to join
- Right-handed
- Healthy with no medical conditions OR have a history of anxiety and/or depression
- Ability to travel to both Palo Alto University and Stanford University
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palo Alto University
Los Altos, California, 94022
Stanford University
Stanford, California, 94035
About this study
Official title: Transdiagnostic Endophenotypes of Anxiety and Depression
Eligible participants will come in for three separate visits in which they will be interviewed, perform a variety of tasks, and undergo a non-invasive MRI scan. The investigators anticipate that (1) participants with anxiety and depression will likely perform differently than the healthy controls on cognitive tasks, (2) participants with anxiety and depression will likely show differences in brain functionality compared to the healthy controls, and (3) depression and anxiety likely share some underlying mechanisms.
Read the detailed description
In order to determine eligibility, a brief phone screen lasting approximately 15 minutes will be conducted. If participants are eligible, they will be asked to come in for three separate visits. During the first visit, participants will complete questionnaires as well as a structured interview with one of the study's staff members at Palo Alto University in Los Altos. During the second visit, participants would come to Palo Alto University in Los Altos and complete questionnaires as well as a testing session involving various tasks. During the third visit, participants would undergo a non-invasive brain scan in which participants would complete a task as well as various questionnaires at Stanford University in Stanford.
The investigators have flexible hours and can work around participants' schedules! To inquire more about participation, participants can either email the investigators at paloalto.study@gmail.com or call the investigators at (650) 417-2000 ext. 3642
- Conditions
- Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depression and anxiety symptoms | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain imaging
Non-invasive MRI brain scan to see function and structure of brain
Measured: Day 1
Assessment of symptoms and daily functioning
Structured Clinical Interview for DSM-IV, General demographic questionnaires, Penn State Worry Questionnaire, Intolerance of Uncertainty Questionnaire, The Positive and Negative Affect Schedule, Behavioral Inhibition Scale/Behavioral Activation Scale, The NEO Five-Factor Inventory, Mood and Anxiety Symptom Questionnaire, Alcohol Use Disorders Identification Test, Behavioral Regulation Index and Metacognition Index, General temperament Survey, Questionnaire of Mental Imagery, Rumination Reflection Questionnaire, Drug Abuse Screening Test, Childhood Trauma Questionnaire- Factor Structure, Emotion Regulation Questionnaire, Trait Meta-Mood Scale
Measured: Day 1
Cognitive assessment
Objective assessment of cognitive strengths and weaknesses via neuropsychological testing session
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start19 Mar 2015
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacie Warren, Ph.D., Palo Alto University
- Investigators
- Stacie Warren, PhD, Principal investigator, Palo Alto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135756
- Sponsor's protocol ID
- 15-003-H
- Status last verified
- May 2018
- First submitted
- 21 Apr 2017
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Endophenotypes of Anxiety and Depression
- ClinicalTrials.gov ID
- NCT03135756
- Acronym / sponsor ID
- 15-003-H
- Conditions
- Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Palo Alto UniversityUniversity, hospital or other
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 1 May 2017 (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.
Eligible participants will come in for three separate visits in which they will be interviewed, perform a variety of tasks, and undergo a non-invasive MRI scan. The investigators anticipate that (1) participants with anxiety and depression will likely perform differently than the healthy controls on cognitive tasks, (2) participants with anxiety and depression will likely show differences in brain functionality compared to the healthy controls, and (3) depression and anxiety likely share some underlying mechanisms.
Detailed description
In order to determine eligibility, a brief phone screen lasting approximately 15 minutes will be conducted. If participants are eligible, they will be asked to come in for three separate visits. During the first visit, participants will complete questionnaires as well as a structured interview with one of the study's staff members at Palo Alto University in Los Altos. During the second visit, participants would come to Palo Alto University in Los Altos and complete questionnaires as well as a testing session involving various tasks. During the third visit, participants would undergo a non-invasive brain scan in which participants would complete a task as well as various questionnaires at Stanford University in Stanford.
The investigators have flexible hours and can work around participants' schedules! To inquire more about participation, participants can either email the investigators at paloalto.study@gmail.com or call the investigators at (650) 417-2000 ext. 3642
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression and anxiety symptoms | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The investigators expect to enroll 50 right-handed, English as first language, adults will be recruited from the community through various advertisements. The investigators expect that 25 will be healthy controls and 25 will be a clinical sample exhibiting clinically significant symptoms of anxiety and depression.
Key inclusion criteria (3 listed)
- Right-handed
- Healthy with no medical conditions OR have a history of anxiety and/or depression
- Ability to travel to both Palo Alto University and Stanford University
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain imaging
Time frame: Day 1
Non-invasive MRI brain scan to see function and structure of brain
Assessment of symptoms and daily functioning
Time frame: Day 1
Structured Clinical Interview for DSM-IV, General demographic questionnaires, Penn State Worry Questionnaire, Intolerance of Uncertainty Questionnaire, The Positive and Negative Affect Schedule, Behavioral Inhibition Scale/Behavioral Activation Scale, The NEO Five-Factor Inventory, Mood and Anxiety Symptom Questionnaire, Alcohol Use Disorders Identification Test, Behavioral Regulation Index and Metacognition Index, General temperament Survey, Questionnaire of Mental Imagery, Rumination Reflection Questionnaire, Drug Abuse Screening Test, Childhood Trauma Questionnaire- Factor Structure, Emotion Regulation Questionnaire, Trait Meta-Mood Scale
Cognitive assessment
Time frame: Day 1
Objective assessment of cognitive strengths and weaknesses via neuropsychological testing session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Stacie Warren, PhD principal investigator
Palo Alto University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Palo Alto University at 2 sites 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brain imaging (time frame: Day 1). 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?
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 11 May 2018.