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Influence of the Noradrenergic System on the Formation of Intrusive Memories

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT02541071
Collaborator
(none)
118
Enrollment
1
Location
3
Arms
11
Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether the activity of the noradrenergic system during an intrusion-inducing stressor influences subsequent intrusive memories.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

The investigators conducted an experimental, double-blind, placebo-controlled study in 118 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg yohimbine, stimulating noradrenergic activity, or 0.15 mg clonidine, inhibiting noradrenergic activity, or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following four days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.

Study Design

Study Type:
Interventional
Actual Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Influence of the Noradrenergic System on the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yohimbine and Stress Film

Administration of 10mg yohimbine before the trauma film.

Behavioral: Stress Film

Drug: Yohimbine
Experimental: Placebo and Stress Film

Administration of placebo before the trauma film.

Behavioral: Stress Film

Drug: placebo
Experimental: Clonidine and Stress Film

Administration of 0.15mg clonidine before the trauma film.

Behavioral: Stress Film

Drug: Clonidine

Outcome Measures

Primary Outcome Measures

  1. Number of intrusive memories [four consecutive days]

    Measured with an intrusion diary

Secondary Outcome Measures

  1. Vividness of intrusive memories [four consecutive days]

    Measured with an intrusion diary

  2. Degree of distress of intrusive memories [four consecutive days]

    Measured with an intrusion diary

Eligibility Criteria

Criteria

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

  • healthy participants

  • German on a native level

Exclusion Criteria:

  • former or present DSM IV Axis I disorders

  • physical illnesses

  • any medication intake (except oral contraceptive)

  • history of sexual abuse or rape

  • pregnancy or lactation period

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychiatry and Psychotherapy, Charité University Medicine Berlin, Campus Benjamin Franklin Berlin Germany 12203

Sponsors and Collaborators

  • Charite University, Berlin, Germany

Investigators

  • Study Director: Stefan Roepke, Dr., Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dipl.- Psych. Felicitas Rombold, Dipl.-Psych., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02541071
Other Study ID Numbers:
  • Rombold_01
First Posted:
Sep 4, 2015
Last Update Posted:
Sep 4, 2015
Last Verified:
Sep 1, 2015
Additional relevant MeSH terms:
Clonidine
Yohimbine

Study Results

No Results Posted as of Sep 4, 2015