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Trial record 3 of 26 for:    methylparaben

Vasopressin and the Social Brain

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ClinicalTrials.gov Identifier: NCT02394054
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Matthew Lieberman, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE January 22, 2015
First Posted Date  ICMJE March 20, 2015
Last Update Posted Date August 10, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2015)
Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion [ Time Frame: Between 40-115 minutes post administration ]
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the exclusion portion of the cyberball task (Williams et al., 2012) versus the inclusion portion. A first-level analysis will compare [(friend exclusion>friend inclusion)>(stranger exclusion>stranger inclusion)] for each participant. A second-level group analysis will compare these first-level contrasts between the vasopressin and placebo groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02394054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2015)
  • Ratings of empathic concern after witnessing social exclusion in a friend or a stranger [ Time Frame: Between 40-115 minutes post administration ]
    Ratings of empathic concern will be calculated for each participant by deriving a composite from self-report ratings of sympathy and compassion. Using a mixed 2 (friend, stranger) x 2 (vasopressin, placebo) factorial design, comparisons of these ratings will then be made for those in the vasopressin vs. placebo groups. Main effects of drug condition (vasopressin, placebo) as well as the interaction between drug condition and target (friend, stranger) will be analyzed at a significance level of p<.05.
  • Altruism and punishment as measured by number of points given to excluders and those excluded [ Time Frame: Between 40-115 minutes post administration ]
    Ratings of altruism and punishment will be calculated by examining how many point (1-10) participants decide to allocate towards the friend-excluder, stranger-excluder, excluded friend, and excluded stranger after watching each social exclusion game. Using a mixed 2 (friend, stranger) x 2 (vasopressin, placebo) factorial design, comparisons of these ratings will then be made for those in the vasopressin vs. placebo groups. Main effects of drug condition (vasopressin, placebo) and target (friend, stranger), as well as an interaction between drug condition and target will be analyzed at a significance level of p<.05.
  • Changes in neural brain activity, as observed by fMRI, while attempting to detect deception [ Time Frame: Between 40-115 minutes post administration ]
    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the deception detection task versus a control task. A first-level analysis will compare deception-detection>control for each participant. A second-level group analysis will compare this first-level contrast between the vasopressin and placebo groups.
  • Accuracy of deception detection as measured by self-report [ Time Frame: Between 40-115 minutes post administration ]
    The investigators will compare the percentage of correct deception detection trials for participants in the vasopressin group to those in the placebo group by running a two-tailed t-test with a statistical cutoff of p<.05 to determine significance.
  • Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers [ Time Frame: Between 40-115 minutes post administration ]
    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater while viewing photo stimuli of ones primary caregivers versus viewing photo stimuli of matched strangers. A first-level analysis will compare primary-caregiver-viewing>stranger-viewing for each participant. A second-level group analysis will compare this first-level contrast between the vasopressin and placebo groups.
  • Changes in brain neural activity, observed by fMRI, in response to a reading comprehension task [ Time Frame: Between 40-90 minutes post administration ]
    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the tutor/memorizer and vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during reading comprehension compared with the grammar control passage. First level analyses will compare the response during the reading comprehension passages relative to the grammar control passages. Second level group analyses will compare the first level contrasts between the tutor vs. memorizer groups as well as the vasopressin vs. placebo groups. In regression analyses the investigators will enter each participant's comprehension test score in the tutor and then memorizer condition as a regressor in a whole-brain and ROI analysis to determine which brain regions were more active during the encoding of the reading comprehension passage compared to the grammar control passage.
  • Performance on a memory test of reading comprehension as measured by percentage of questions answered correctly [ Time Frame: Between 40-90 minutes post administration ]
    Accuracy will be calculated for each participant by dividing the number of correct responses by the total number of questions. The investigators will then conduct a between-subjects 2x2 ANOVA on the accuracy scores for the four groups of interest (i.e., vasopressin-tutor, vasopressin-memorizer, placebo-tutor, placebo-memorizer). A significance level of p<.05 will be used to determine whether there are significant differences between the groups. The investigators will examine whether there is a main effect of either factor (vasopressin vs. placebo, tutor vs. memorize) as well as an interaction between the factors of interest.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vasopressin and the Social Brain
Official Title  ICMJE Vasopressin's Effect on Behavior and Neural Activity During Social Cognition Tasks
Brief Summary

It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Recent research has begun to focus on vasopressin, a neuropeptide that is naturally produced in the hypothalamus, because administration of this neuropeptide has been associated with empathy, cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions associated with social and emotional processes. To date, several aspects of vasopressin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal vasopressin on several tasks involving learning and social processes. In addition, the investigators will explore associated neural activity through functional magnetic resonance imaging (fMRI). Results from the study will inform our understanding of the neurobiology of socioemotional processes.

The investigators hypothesize that compared to placebo, vasopressin will improve deception detection, increase empathy and altruism, enhance responses to photo stimuli of primary caregivers, and improve learning when the subject has a prosocial goal of teaching another person. These effects will manifest in behavioral and neural activity. It is also hypothesized that main effects will not be found for vasopressin, but rather, analyses of relevant moderators will elucidate these findings.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Social Psychology
Intervention  ICMJE
  • Drug: Intranasal vasopressin
    Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).
  • Drug: Intranasal placebo
    Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
Study Arms  ICMJE
  • Experimental: Intranasal vasopressin
    Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).
    Intervention: Drug: Intranasal vasopressin
  • Placebo Comparator: Intranasal placebo
    2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter. Participants will self-administer 5 puffs per nostril.
    Intervention: Drug: Intranasal placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2017)
84
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2015)
60
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-30 years of age
  • Healthy (see below)
  • Fluent in English
  • Right-handed

Exclusion Criteria:

  • Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women
  • Symptoms of runny nose due to allergies/cold or other reason
  • Current restricted fluid intake for any reason
  • Heart disease
  • Hypertension
  • History of myocardial infarction
  • History of cardiac arrhythmia
  • Kidney or liver disease
  • Vascular disease
  • Epilepsy
  • Migraine
  • Asthma
  • Nephritis
  • Diabetes and other endocrine diseases
  • Frequent or unexplained fainting
  • History of stroke
  • Aneurysm or brain hemorrhage
  • Active psychiatric diagnosis
  • Current psychopharmacologic treatment
  • Drug or alcohol abuse
  • Medical or neurological illness
  • Regular use of medication (e.g., vasoconstrictive medications)
  • Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including daily non-steroidal anti-inflammatory drugs
  • Smoking more than 15 cigarettes a day
  • Consumption of any alcoholic beverages in the past 24 hours will be excluded
  • Elevated blood pressure (>135/90)
  • Low blood pressure (<90/55)
  • Body temperature >100.1 F
  • Left-handed
  • Claustrophobia
  • Presence of metal in their body
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02394054
Other Study ID Numbers  ICMJE 11-003565-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Lieberman, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew D Lieberman, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP