Memory Clinical Trial
— ESMoryOfficial title:
Dissecting the Role of Estradiol in Mediating Gender-specific Anxiolytic and Prosocial Effects of Oxytocin
Verified date | April 2020 |
Source | University Hospital, Bonn |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to examine a behavioral and neural framework for understanding the sex-specific effects of the neuropeptide oxytocin (OXT). Using hormonal, behavioral and neuroimaging readouts, it is planned to explore the interplay of OXT and estradiol as a potential mechanism mediating sexual dimorphic effects.
Status | Completed |
Enrollment | 487 |
Est. completion date | January 25, 2020 |
Est. primary completion date | January 25, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - right handed - healthy male & female volunteers - women will be tested in their follicular phase (Day 0-5) Exclusion Criteria: - smoking - pregnancy - hormonal contraception - current psychiatric illness - current psychiatric medication or psychotherapy - Study 2: MRI contraindication (e.g. metal in body, claustrophobia) |
Country | Name | City | State |
---|---|---|---|
Germany | Deparment of Psychiatry and Medical Psychology | Bonn |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
Hariri AR, Tessitore A, Mattay VS, Fera F, Weinberger DR. The amygdala response to emotional stimuli: a comparison of faces and scenes. Neuroimage. 2002 Sep;17(1):317-23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Electrodermal responses to fear-conditioned stimuli | In Study 1, electrodermal responses will be measured during the fear conditioning and fear extinction tasks. The paradigm is an adapted version of a validated fear-conditioning procedure. Before the start of the paradigm a baseline of electrodermal activity is recorded for 60 seconds. During the conditioning session four neutral conditioned stimuli (two CS+ A and two CS+ B) are paired with an aversive US (electric shock) in 75 % contingency, whereas two other neutral stimuli are never paired with the US (non-fear-associated stimulus [CS-]). In CS+ trials electric shocks are administered during the last 500 milliseconds of the trial. In the fear extinction session all CS+ and CS- are presented in the absence of electric shocks. Oxytocin and estradiol baseline concentrations will be tested as moderator variables. | 3 hours after gel administration and 30 minutes after nasal spray administration | |
Primary | Emotion recognition thresholds | In Study 1, emotion recognition will be measured. During the emotion recognition task, emotional faces are presented and participants are required to indicate the perceived emotion ("neutral", "fearful", "happy", "disgusted", "angry", "not sure") in a following self-paced phase. A Bayesian adaptive procedure ("QUEST") will be used to determine the stimulus presentation and to estimate individual emotion thresholds. Oxytocin and estradiol baseline concentrations will be tested as moderator variables. | 200 minutes after gel administration and 50 minutes after nasal spray administration | |
Primary | Resting state functional connectivity | In Study 2, resting state functional connectivity will be measured. The resting state fMRI analysis will focus on functional connectivity between regions-of-interest (ROIs) associated with emotional processing (i.e. amygdala, cingulate and prefrontal cortex, insula, striatal areas). Oxytocin and estradiol baseline concentrations will be tested as moderator variables. | 3 hours after gel administration and 30 minutes after nasal spray administration | |
Primary | Neural responses to emotional faces | In Study 2, neural responses to emotional faces will be measured. Functional magnetic resonance imaging will be performed to measure the blood-oxygen-level dependent signal in response to emotional faces. Analyses will focus on regions-of-interest associated with emotional processing (i.e. amygdala, cingulate and prefrontal cortex, insula, striatal areas). Oxytocin and estradiol baseline concentrations will be tested as moderator variables. | 190 minutes gel administration and 40 minutes after nasal spray administration | |
Primary | Neural responses to an emotional subsequent memory task | In Study 2, neural responses to an emotional subsequent memory task will be measured. Functional magnetic resonance imaging will be performed to measure the blood-oxygen-level dependent signal in response to emotional scenes. The investigators plan to analyze scenes depending on valence (positive, negative, neural) and sociality (social, non-social). Furthermore, remembered and non-remembered emotional pictures will be compared. To classify pictures as remembered and non-remembered, participants will perform a memory recognition task three days after the MRI scan. The recognition task will include pictures shown in the scanner and distractors. Analyses will focus on regions-of-interest associated with emotional processing and memory (i.e. amygdala, hippocampus, cingulate and prefrontal cortex, insula, striatal areas). Oxytocin and estradiol baseline concentrations will be tested as moderator variables. | 200 minutes after gel administration and 50 minutes after nasal spray administration | |
Secondary | Changes in oxytocin plasma concentration | In both studies, blood samples will be collected 5 minutes before gel administration and 5 minutes after the last task. | 5 minutes before gel administration and 5 minutes after the last task | |
Secondary | Changes in estrogen plasma concentration | In both studies, blood samples will be collected 5 minutes before gel administration and 5 minutes after the last task. | 5 minutes before gel administration and 5 minutes after the last task | |
Secondary | Contingency ratings of fear-conditioned stimuli | In Study 1, during the first 3500 ms of a trial in the fear conditioning and fear extinction tasks participants will be required to indicate via button press whether they expect to receive an electric shock (yes, no, not sure). Oxytocin and estradiol baseline concentrations will be tested as moderator variables. | 3 hours after gel administration and 30 minutes after nasal spray administration | |
Secondary | Ultimatum game tasks | In Study 1, bargaining behavior will be measured in three different versions of the Ultimatum Game (restricted, unrestricted and computer ultimatum game). All participants will play as responders in the three versions. As a cover story, participants will be told that they play against real partners, who took part in previous experiments. In the restricted version of the Ultimatum Game, the proposer can only decide between two given options. As such, chosen offers are either framed as fair or unfair depending on the alternative option. In the unrestricted Ultimatum Game, the proposer can freely decide how to split 10 Euro. In addition, participants will complete 24 trials of a computer version of the unrestricted Ultimatum Game, in which the word "computer" will be shown instead of a picture of the proposer. Estradiol baseline concentrations will be tested as moderator variables. | 150 minutes after gel administration | |
Secondary | Delayed discounting task | In Study 1, subjects will perform a delayed discounting task in order to assess their control of impulsive preferences. Participants will be asked to choose between small immediate rewards and larger later rewards. Estradiol baseline concentrations will be tested as moderator variables. | 170 minutes after gel administration | |
Secondary | Changes in the Multifaceted Empathy Test (MET) | In Study 2, participants' empathy will be assessed with the Multifaceted Empathy Test (MET) which includes photographs showing people in emotionally charged situations. Participants will be asked to infer the mental states of the individuals shown (cognitive empathy) and to rate their emotional response to the picture (emotional empathy). Participants will perform the MET twice: 1. before the fMRI in the second session and and 2. three days following the fMRI. Estradiol baseline concentrations will be tested as moderator variables. | 135 minutes after the gel administration on the fMRI acquisition day and three days after the fMRI acquisition day | |
Secondary | Changes in the Prisoner's Dilemma | In Study 2, the investigators will use an iterated version of the prisoner's dilemma to evaluate the participant's cooperative behavior. The participants will have to decide multiple times whether they want to betray their opponent or whether they choose to cooperate. Participants will perform the Prisoner's Dilemma twice: 1. before the fMRI in the second session and and 2. three days following the fMRI.Estradiol baseline concentrations will be tested as moderator variables. | 155 minutes after the gel administration on the fMRI acquisition day and three days after the fMRI acquisition day |
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