NCT07317895

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Aug 2027

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 19, 2025

Last Update Submit

December 19, 2025

Conditions

Depressed

Keywords

DepressionEstrogenProgesterone

Outcome Measures

Primary Outcomes (1)

  • Identification ovarian hormone affect sensitivity

    Identify depressed adolescents assigned female at birth with depressed affect sensitivity to changes in ovarian hormones across the menstrual cycle.

    90 days

Study Arms (1)

SOHDA corort

Main study cohort

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Depressed, naturally cycling adolescents assigned female at birth.

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or taking any hormonal or cycle altering medications/devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

MeSH Terms

Conditions

Consciousness DisordersDepression

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Whitney Hindmarch, PhD

CONTACT

587-534-7260whitney.hindmarch@ucalgary.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)