Influence of the Noradrenergic System on the Formation of Intrusive Memories

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

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.

Study Overview

• Status: Completed
• Conditions: Intrusive Memories
• Intervention / Treatment: Drug: placebo; Behavioral: Stress Film; Drug: Yohimbine; Drug: Clonidine

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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Department of Psychiatry and Psychotherapy, Charité University Medicine Berlin, Campus Benjamin Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.	Drug: placebo; Behavioral: Stress Film
Experimental: Clonidine and Stress Film; Administration of 0.15mg clonidine before the trauma film.	Behavioral: Stress Film; Drug: Clonidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intrusive memories	Measured with an intrusion diary	four consecutive days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vividness of intrusive memories	Measured with an intrusion diary	four consecutive days
Degree of distress of intrusive memories	Measured with an intrusion diary	four consecutive days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Urological Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Adrenergic alpha-Antagonists; Mydriatics; Adrenergic alpha-2 Receptor Antagonists; Clonidine; Yohimbine
• Other Study ID Numbers: Rombold_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No