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Clinical Trials/NCT02541071
NCT02541071CompletedNot Applicable

Influence of the Noradrenergic System on the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm

Charite University, Berlin, Germany1 site in 1 country118 target enrollmentStarted: November 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
118
Locations
1
Primary Endpoint
Number of intrusive memories

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 44 Years (Adult)
Sex
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

Arms & Interventions

Yohimbine and Stress Film

Experimental

Administration of 10mg yohimbine before the trauma film.

Intervention: Stress Film (Behavioral)

Yohimbine and Stress Film

Experimental

Administration of 10mg yohimbine before the trauma film.

Intervention: Yohimbine (Drug)

Placebo and Stress Film

Experimental

Administration of placebo before the trauma film.

Intervention: Stress Film (Behavioral)

Placebo and Stress Film

Experimental

Administration of placebo before the trauma film.

Intervention: placebo (Drug)

Clonidine and Stress Film

Experimental

Administration of 0.15mg clonidine before the trauma film.

Intervention: Stress Film (Behavioral)

Clonidine and Stress Film

Experimental

Administration of 0.15mg clonidine before the trauma film.

Intervention: Clonidine (Drug)

Outcomes

Primary Outcomes

Number of intrusive memories

Time Frame: four consecutive days

Measured with an intrusion diary

Secondary Outcomes

  • Vividness of intrusive memories(four consecutive days)
  • Degree of distress of intrusive memories(four consecutive days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dipl.- Psych. Felicitas Rombold

Dipl.-Psych.

Charite University, Berlin, Germany

Study Sites (1)

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