Influence of the Noradrenergic System on the Formation of Intrusive Memories

NCT ID: NCT02541071

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Intrusive Memories

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Yohimbine and Stress Film

Administration of 10mg yohimbine before the trauma film.

Group Type EXPERIMENTAL

Stress Film

Intervention Type BEHAVIORAL

Yohimbine

Intervention Type DRUG

Placebo and Stress Film

Administration of placebo before the trauma film.

Group Type EXPERIMENTAL

Stress Film

Intervention Type BEHAVIORAL

placebo

Intervention Type DRUG

Clonidine and Stress Film

Administration of 0.15mg clonidine before the trauma film.

Group Type EXPERIMENTAL

Stress Film

Intervention Type BEHAVIORAL

Clonidine

Intervention Type DRUG

Interventions

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Stress Film

Intervention Type BEHAVIORAL

Yohimbine

Intervention Type DRUG

Clonidine

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Dipl.- Psych. Felicitas Rombold

Dipl.-Psych.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Roepke, Dr.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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Rombold_01

Identifier Type: -

Identifier Source: org_study_id

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