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Behavioural Intervention

Group 2 - Cohort 2a for Mood Disorders

Q: Is the enrollment for this investigation currently open?

<p>According to the details on clinicaltrials.gov, recruitment for this investigation is currently closed. The trial was initially listed on June 1st, 2024, with the last update made on February 20th, 2024. While this specific study is no longer recruiting participants, there are a total of 1733 ongoing trials that are actively enrolling eligible individuals at present.</p>

Q: Is the age criterion for participating in this research limited to individuals below 50 years of age?

<p>Individuals aged between 18 and 50 are eligible for participation in this clinical investigation. Notably, there are a total of 334 trials catering to the younger demographic and 1202 focused on individuals over the age of 65.</p>

N/A

Waitlist Available

Led By Lauren M Osborne, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study Group 2: Arm 2 - Women and transgender men 18-50 years of age, ≤ 6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI

Study Group 2: Arm 4 - Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the Mini International Neuropsychiatric Interview (MINI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 fmri scans in the 10 days before the intervention and up to 7 fmri scans in the 6 weeks post-intervention.

Awards & highlights

Study Summary

This trial aims to study how whole-body hyperthermia (WBH) can be used as a quick and effective therapy for treating postpartum depression in women. The study will involve enrolling different

Who is the study for?

This trial is for healthy postpartum women or transgender men, and adults with major depression or anxiety disorders. Participants must be aged 18-50, and for postpartum individuals, within 6 months after giving birth. The study excludes anyone outside this age range or not meeting the specific mental health criteria.Check my eligibility

What is being tested?

The trial is testing whole-body hyperthermia (WBH) as a treatment for mood and anxiety disorders including postpartum depression. It involves one session of WBH therapy and tracks changes using fMRI scans in various participant groups over time to assess effectiveness.See study design

What are the potential side effects?

While the side effects are not explicitly listed here, potential risks may include discomfort due to heat exposure during WBH treatment such as sweating, dehydration, or heat-related stress on the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman or transgender man, aged 18-50, within 6 months postpartum, and have been diagnosed with postpartum depression.

Select...

I am between 18-50 years old and have been diagnosed with major depression or generalized anxiety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the course of the intervention: when participant core temperature reaches 38.5 c for two consecutive minutes or after 140 minutes have passed.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the course of the intervention: when participant core temperature reaches 38.5 c for two consecutive minutes or after 140 minutes have passed.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the course of the intervention: when participant core temperature reaches 38.5 c for two consecutive minutes or after 140 minutes have passed. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change in EEG amplitude.

Percent change in EEG frequency.

Secondary outcome measures

Individualized precision functional brain maps.

Mean change from baseline in inflammatory activity as measured by pro-inflammatory cytokines.

Mean change in average 24-hour core temperature.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Group 3 - Cohort 2dExperimental Treatment2 Interventions

Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Group II: Group 3 - Cohort 2cExperimental Treatment2 Interventions

Healthy adults of both sexes 18-50 years of age

Group III: Group 3 - Cohort 2bExperimental Treatment2 Interventions

Women and transgender men 18-50 years of age, <6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI

Group IV: Group 3 - Cohort 2aExperimental Treatment2 Interventions

Healthy women or transgender men 18-50 years of age, <6 months postpartum

Group V: Group 2 - Cohort 2dExperimental Treatment1 Intervention

Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Group VI: Group 2 - Cohort 2cExperimental Treatment1 Intervention

Healthy adults of both sexes 18-50 years of age

Group VII: Group 2 - Cohort 2bExperimental Treatment1 Intervention

Women and transgender men 18-50 years of age, <6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI

Group VIII: Group 2 - Cohort 2aExperimental Treatment1 Intervention

Healthy women or transgender men 18-50 years of age, <6 months postpartum

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fMRI

2019

Completed Phase 3

~1730

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,069 Total Patients Enrolled

1 Trials studying Mood Disorders

29 Patients Enrolled for Mood Disorders

Lauren M Osborne, PhDPrincipal InvestigatorWeill Medical College of Cornell University

Jonathan Power, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this investigation currently open?

"According to the details on clinicaltrials.gov, recruitment for this investigation is currently closed. The trial was initially listed on June 1st, 2024, with the last update made on February 20th, 2024. While this specific study is no longer recruiting participants, there are a total of 1733 ongoing trials that are actively enrolling eligible individuals at present."

Answered by AI

Is the age criterion for participating in this research limited to individuals below 50 years of age?

"Individuals aged between 18 and 50 are eligible for participation in this clinical investigation. Notably, there are a total of 334 trials catering to the younger demographic and 1202 focused on individuals over the age of 65."

Answered by AI

Recent research and studies

Journal of the American Academy of Child & Adolescent PsychiatryJournal

Maternal Depression and Anxiety Across the Postpartum Year and Infant Social Engagement, Fear Regulation, and Stress Reactivity

Feldman, Ruth, Adi Granat, Clara Pariente, Hannah Kanety, Jacob Kuint, and Eva Gilboa-Schechtman. 2009. “Maternal Depression and Anxiety Across the Postpartum Year and Infant Social Engagement, Fear Regulation, and Stress Reactivity”. Journal of the American Academy of Child & Adolescent Psychiatry. Elsevier BV. doi:10.1097/chi.0b013e3181b21651.

clinicaltrials.govStudy

Whole-Body Hyperthermia for Mood and Anxiety Disorders

2024. "Whole-Body Hyperthermia for Mood and Anxiety Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06144294.

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