Healthy Clinical Trial
Official title:
Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model
Verified date | February 2018 |
Source | University Hospital, Bonn |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 18, 2017 |
Est. primary completion date | March 18, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Psychiatry, University of Bonn | Bonn |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total number of intrusions following the first trauma movie exposure. | The participants will be asked to complete intrusion diaries at home in the evening of the days 1 to 3. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness. | Three days following the first trauma movie exposure. | |
Primary | Total number of intrusions following the second trauma movie exposure. | The participants will be asked to complete intrusion diaries at home in the evening of the days 4 to 6. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness. | Three days following the second trauma movie exposure. | |
Primary | Neural responses to emotional faces in the amygdala. | Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions. | Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min. | |
Primary | Neural responses to emotional faces in the prefrontal cortex. | Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate prefrontal cortex responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions. | Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min. | |
Primary | fMRI resting state data | Participants will be instructed to lie still with open eyes during the resting state measurement and not think of anything in particular. | Functional data will be acquired for 6 min. | |
Primary | Trauma disclosure (time spend discussing the movie) | The intrusion diaries will contain a question for how long participants discussed the trauma movie. | Six days following the first trauma movie exposure. | |
Secondary | Changes in pupil diameter in response to the trauma movie | Changes in pupil diameter will be measured. | 2 min baseline before the trauma movie and during 15 min of the trauma movie. | |
Secondary | Changes in skin conductance level in response to the trauma movie | Changes in skin conductance level will be measured. | 2 min baseline before the trauma movie and during 15 min of the trauma movie. | |
Secondary | Changes in respiration rate in response to the trauma movie | Changes in respiration rate will be measured. | 2 min baseline before the trauma movie and during 15 min of the trauma movie. | |
Secondary | Salivary oxytocin concentrations | Saliva samples will be collected before and after the trauma movie to assess changes in oxytocin concentrations. | Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie. | |
Secondary | Salivary cortisol concentrations | Saliva samples will be collected before and after the trauma movie to assess changes in cortisol concentrations. | Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie. | |
Secondary | Questionnaire measurement of mood (PANAS) | Positive and negative affect will be assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale. | 10 min before and 10 min after the trauma movie. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |