- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317895
Sensitivity to Ovarian Hormones and Depression in Adolescents (SOHDA)
The goal of this observational study is to learn about the relationship between changes in ovarian hormones (estrogen and progesterone) and adolescent depression. The main question it aims to answer is:
Can we identify a subset adolescents assigned female at birth with a history of depression who are particularly sensitive to changes in ovarian hormones? Participants will be monitoring daily absolute ovarian hormone levels at home using the Mira Analyzer and answer online survey questions about their mental health for 90 days.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Whitney Hindmarch, PhD
- Phone Number: 587-534-7260
- Email: whitney.hindmarch@ucalgary.ca
Study Locations
-
-
Alberta
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Calgary, Alberta, Canada, T2N1N4
- University of Calgary
-
Contact:
- Whitney Hindmarch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Assigned female at birth, at least 1 year post-menarche, naturally cycling, history of depression or symptoms of depression, and able to read and write in English.
Exclusion Criteria:
- Pregnant or taking any hormonal or cycle altering medications/devices.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
SOHDA corort
Main study cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification ovarian hormone affect sensitivity
Time Frame: 90 days
|
Identify depressed adolescents assigned female at birth with depressed affect sensitivity to changes in ovarian hormones across the menstrual cycle.
|
90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB25-1647
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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