Influence of the Noradrenergic System on the Formation of Intrusive Memories

Intrusive Memories Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541071
• Other study ID #: Rombold_01
• Status: Completed
• Phase: N/A
• First received: August 6, 2015
• Last updated: September 3, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: September 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Intrusive Memories

Intervention

Behavioral:
• Stress Film

Drug:
• Yohimbine

• Clonidine

• placebo

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, Charité University Medicine Berlin, Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intrusive memories	Measured with an intrusion diary	four consecutive days	No
Secondary	Vividness of intrusive memories	Measured with an intrusion diary	four consecutive days	No
Secondary	Degree of distress of intrusive memories	Measured with an intrusion diary	four consecutive days	No