Sensitivity to Ovarian Hormones and Depression in Adolesc... | NCT07317895

Studies
Sensitivity to Ovarian Hormones and Depression in Adolescents

NCT07317895

Sponsor

University of Calgary

Status

Not yet recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

94Estimated

Phase

Not provided

Conditions

Depressed

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Estimated

Primary Completion Date

Mar 31, 2027Estimated

Completion Date

Aug 31, 2027Estimated

First Submitted Date

Dec 19, 2025

First Submission Date that Met QC Criteria

Dec 19, 2025

First Posted Date

Jan 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2025

Last Update Posted Date

Jan 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

94Estimated

Label	Type	Description	Intervention Names
SOHDA corort		Main study cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Depressed, naturally cycling adolescents assigned female at birth.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Whitney Hindmarch, PhD	Contact	587-534-7260		whitney.hindmarch@ucalgary.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary		Calgary	Alberta	T2N1N4	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003244	Consciousness Disorders
D003863	Depression

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided