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A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances

A Phase-2, Double-Blind, Randomized, Placebo-controlled, Crossover Dose-Finding, Laboratory-based Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances

NCT06685965•Reconnect Labs

View on ClinicalTrials.gov

Summary

Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares. Current treatments often do not provide sufficient relief, especially for sleep problems. This study aims to determine whether dexmedetomidine - a medication already used in intensive care - can improve sleep quality in PTSD patients.

Detailed Description

Participants spend one screening night followed by three treatment nights in the sleep lab, where they receive either a low dose, a high dose of dexmedetomidine, or a placebo. All participants receive all three options, with only the sequence differing. Participants and the study team are blinded and thus do not know which dose (or placebo) has been assigned.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, aged ≥18 and ≤64 years (inclusive)
•Diagnosis of PTSD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for more than 6 months
•PTSD diagnosis assessed with CAPS-5 (life-time) severity ≥ 2
•Sleep disturbance, e.g., difficulty falling or staying asleep, or restless sleep (Criterion E6 of the DSM-5 criteria for PTSD) is present for at least a month prior to screening and causes clinically significant distress or impairment in social, occupational, or other important areas of functioning
•Sleep disturbance assessed with the PSQI; severity ≥ 5
•Ability (verified by investigator) and willingness to provide informed consent as documented by dated signature

Exclusion Criteria

•Inability to comply with sleep-wake schedule related study requirements, e.g. due to crossing of time zones (≥ 2), extreme chronotypes, shift working within 2 weeks prior to the screening visit, or planned shift work during the study, self-reported usual daytime napping ≥1 hour per day, and ≥3 days per week
•Inability to follow the procedures of the study, e.g. due to insufficient understanding of the German language used in the study as evaluated by the investigator or anticipated problems with overnight stays at the sleep laboratory
•Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dose; administration of a biological product (e.g. vaccines, blood components, gene therapies, tissues, etc.) in the context of a clinical research study within 90 days prior to the first dose; or concomitant participation in an investigational study involving drug or device administration
•Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) not willing to use one of the following acceptable contraceptive methods throughout the study and for at least 3 months after the last study drug administration:
•○ Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
•Females of non-childbearing potential who are neither:
•* Post-menopausal (status defined as an absence of menses for at least 12 months prior to the first study drug administration); or
•* Surgically sterilized (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration)
•Male participants who are not vasectomised for at least 6 months prior to dosing and who are sexually active with a female partner of childbearing potential not willing to use one of the following acceptable contraceptive methods from the first dose and for 3 months after the last dose:
•○ Use of condom and/or hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
+37 more criteria

Locations (1)

Human Sleep Pharmacology, University of Zurich

Zurich, Canton of Zurich, Switzerland

Key Dates

Start Date

September 10, 2025

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

September 16, 2025

Enrollment

ESTIMATED participants

Conditions

Posttraumatic Stress Disorder (PTSD)Sleep Disturbances and Insomnia

Interventions

RE03

DRUG

Placebo

DRUG

Contacts

Robin von Rotz, MSc

CONTACT

+41797990831 robin@reconnect-labs.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances

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Exclusion Criteria

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