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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

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.

Condition or disease Intervention/treatment Phase
Intrusive Memories Drug: Oxytocin nasal spray Drug: Placebos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin and trauma film paradigm Drug: Oxytocin nasal spray
Placebo Comparator: Placebo and trauma film paradigm Drug: Placebos
Placebo nasal spray




Primary Outcome Measures :
  1. Intrusive memories [ Time Frame: four consecutive days ]
    Influence of oxytocin on the development of intrusive memories measured with an intrusion diary


Secondary Outcome Measures :
  1. 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

  2. Genetic polymorphism [ Time Frame: four consecutive days ]
    Influence of genetic polymorphism of the oxytocin receptor on intrusive memories measured with an intrusion diary

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031405


Locations
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Germany
Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
Central Institute of Mental Health, Mannheim
Investigators
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Study Director: Stefan Roepke, PD Dr. Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
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Responsible Party: Katharina Schultebraucks, PhD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03031405    
Other Study ID Numbers: Charite2017-Oxytocin-Study
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: January 2017
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs