Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06263738 · ClinicalTrials.gov registry record · NA
Cold and Heat Investigation to Lower Levels of Depression
A NA study of Depression and Mood Disorders, sponsored by Barry Sandler.
- Recruiting
- Registry status
- NA
- Development phase
- 162
- Enrollment target
- 1
- Study location
NCT06263738: Recruiting NA study of Depression and Mood Disorders, sponsored by Barry Sandler.
NCT06263738 is a NA study of Depression and Mood Disorders that is actively recruiting participants, run by Barry Sandler. The registered enrollment target is 162 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06263738, a NA study of Depression and Mood Disorders, is actively recruiting participants, sponsored by Barry Sandler.
- RECRUITING
- Registry status
- NA
- Development phase
- 162 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments.
Primary Outcome
The MADRS is a validated 10-item questionnaire to assess depression severity and is commonly used to assess efficacy of an intervention in clinical trials. Each item of the MADRS is measured on a scale of 0 to 6 (for a total score of 0 to 60) with higher scores indicating more severe depression. The MADRS includes questions on the following symptoms: 1. Reported sadness; 2. Apparent sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8.
Conditions Studied
Interventions
- PROCEDURE Whole Body Hyperthermia
- PROCEDURE Cold Water Plunge
Study Locations (1)
Colorado
- Vail Health Behavioral Health Innovation Center - Edwards
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2024-05-14 |
| Est. Completion | 2027-04-01 |
| Phase | NA |
What NCT06263738 shows while recruiting
NCT06263738 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Whole Body Hyperthermia is the first listed.
NCT06263738 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06263738 about?
NCT06263738 is a clinical study titled "Cold and Heat Investigation to Lower Levels of Depression". This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete...
What is the current status of trial NCT06263738?
This trial is currently recruiting. It is a NA study. The enrollment target is 162 participants. The study started on 2024-05-14. Estimated completion is 2027-04-01.
What conditions does trial NCT06263738 study?
This clinical trial studies the following conditions: Depression, Mood Disorders, Healthy (Controls).
What interventions are being tested in trial NCT06263738?
The interventions under investigation include: Whole Body Hyperthermia (PROCEDURE), Cold Water Plunge (PROCEDURE).
Who is sponsoring clinical trial NCT06263738?
This trial is sponsored by Barry Sandler, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06263738 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06263738's enrollment target sits among peer trials
162 235th of 679 higher than 444 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Reaching Out to Distressed Medical Residents, Fellows and Faculty
RECRUITING · NA
-
IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
RECRUITING · NA
-
Dosing rTMS for Depression Post-SCI
RECRUITING · NA
-
Exploring Virtual Reality Adventure Training Exergaming
RECRUITING · NA
-
Brief Interventions for Coping with Distress
RECRUITING · NA
-
Reducing Suicide Risk Among Aging Caregivers of Persons With AD/ADRD
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02347111 · 162 participants · Phase 4
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
- NCT02610426 · 162 participants
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer
- NCT05040711 · 162 participants · NA
mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
- NCT05514717 · 162 participants · Phase 1
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy