Oxytocin, Trauma Disclosure and Intrusions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-03-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects. Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC) subregions. In up to 50 % of the cases, resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress disorder (PTSD). Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic effects. Recent clinical trials provide preliminary evidence that post-trauma administration of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals exhibiting early PTSD symptoms prior to the onset of the disorder. However, the underlying neurobiological mechanisms are unclear. Therefore, the rationale of the present project is to expose a sample of healthy participants to experimental trauma in order to explore the circuit mechanisms by which OXT influences, and interferes with, traumatic experience. Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses during an emotional face matching task and resting state functional connectivity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oxytocin Administration and Emotion Recognition Abilities in Adults Reporting Adverse Childhood Experiences

NCT03335085

Healthy

COMPLETED NA

Oxytocin and the Processing of Social Stress-Associated Chemosignals

NCT03265899

Healthy Volunteers

COMPLETED PHASE1

Oxytocin and Social Cognition

NCT01606462

Healthy Male Volunteers

COMPLETED PHASE1

Effects of Oxytocin on Cognitive and Reactive Fear

NCT04292444

Oxytocin

UNKNOWN PHASE1

Dose-dependent Effects of Oxytocin on the Amygdala and Reward System

NCT03846739

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days 1 and 4 of the study. After the first experimental trauma and after the first functional magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT or placebo in three different groups (1. OXT for six days, 2. OXT for three days and then placebo for three days, 3. placebo for six days). The same fMRI tasks will be used after the first and second trauma exposure (i.e. one measurement before the treatment and one measurement after three days of treatment).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxytocin (6 days)

Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure and three days after the second trauma movie exposure (24 IU per day)

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Intranasal administration, 24 international units (IU) oxytocin.

Oxytocin (3 days)

Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure (24 IU per day) and placebo nasal spray for three days after the second trauma movie exposure

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Intranasal administration, 24 international units (IU) oxytocin.

Placebo

Placebo nasal spray for six days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo nasal sprays contain identical ingredients except for the peptide itself.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxytocin

Intranasal administration, 24 international units (IU) oxytocin.

Intervention Type DRUG

Placebo

The placebo nasal sprays contain identical ingredients except for the peptide itself.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

syntocinon

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy female volunteers
* Right-handed

Exclusion Criteria

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Hormonal contraception
* MRI contraindication (e.g. metal in body, claustrophobia)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes