NCT02541071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

August 6, 2015

Last Update Submit

September 3, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of intrusive memories

    Measured with an intrusion diary

    four consecutive days

Secondary Outcomes (2)

  • Vividness of intrusive memories

    four consecutive days

  • Degree of distress of intrusive memories

    four consecutive days

Study Arms (3)

Yohimbine and Stress Film

EXPERIMENTAL

Administration of 10mg yohimbine before the trauma film.

Behavioral: Stress FilmDrug: Yohimbine

Placebo and Stress Film

EXPERIMENTAL

Administration of placebo before the trauma film.

Behavioral: Stress FilmDrug: placebo

Clonidine and Stress Film

EXPERIMENTAL

Administration of 0.15mg clonidine before the trauma film.

Behavioral: Stress FilmDrug: Clonidine

Interventions

Stress FilmBEHAVIORAL
Clonidine and Stress FilmPlacebo and Stress FilmYohimbine and Stress Film
Yohimbine and Stress Film
Clonidine and Stress Film
Placebo and Stress Film

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy participants
  • German on a native level

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, State of Berlin, 12203, Germany

Location

MeSH Terms

Interventions

YohimbineClonidine

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Stefan Roepke, Dr.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipl.-Psych.

Study Record Dates

First Submitted

August 6, 2015

First Posted

September 4, 2015

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations