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The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031405
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Central Institute of Mental Health, Mannheim
Information provided by (Responsible Party):
Katharina Schultebraucks, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE January 18, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE January 15, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Intrusive memories [ Time Frame: four consecutive days ]
Influence of oxytocin on the development of intrusive memories measured with an intrusion diary
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Noradrenergic System (measured with salivary alpha-amylase - u/ml) [ Time Frame: Day 1 ]
    Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase
  • Genetic polymorphism [ Time Frame: four consecutive days ]
    Influence of genetic polymorphism of the oxytocin receptor on intrusive memories measured with an intrusion diary
  • Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L) [ Time Frame: Day 1 ]
    Influence of oxytocin on the HPA-axis measured with salivary cortisol
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 The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories
Official Title  ICMJE The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder
Brief Summary The purpose of the study is to examine whether oxytocin and oxytocin receptor gene polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Intrusive Memories
Intervention  ICMJE
  • Drug: Oxytocin nasal spray
  • Drug: Placebos
    Placebo nasal spray
Study Arms  ICMJE
  • Experimental: Oxytocin and trauma film paradigm
    Intervention: Drug: Oxytocin nasal spray
  • Placebo Comparator: Placebo and trauma film paradigm
    Intervention: Drug: Placebos
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 19, 2018)
220
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
130
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy female volunteers
  • German on a native level

Exclusion Criteria:

  • former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
  • any physical illnesses
  • any medication intake (except oral contraceptive)
  • history of traumatic experience, e.g. history of sexual abuse or rape
  • pregnancy or lactation period
  • follicular phase of menstrual cycle for all women not using oral contraceptives
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031405
Other Study ID Numbers  ICMJE Charite2017-Oxytocin-Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Katharina Schultebraucks, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Central Institute of Mental Health, Mannheim
Investigators  ICMJE
Study Director: Stefan Roepke, PD Dr. Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
PRS Account Charite University, Berlin, Germany
Verification Date January 2017

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