Emotional Memory Reactivation in Posttraumatic Stress Disorder

NCT01239173 | Terminated Phase 3 DMC

• 1 other identifier: AOM06075/ P060226
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Converging lines of evidence have implicated the amygdala in the pathophysiology of posttraumatic stress disorder. The primary purpose of our study is to assess the effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic stress disorder; functional Magnetic Resonance Imaging; Amygdala; emotion regulation; memory

Outcome Measures

Primary Outcomes (1)

• Effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder

  34 days

Secondary Outcomes (3)

• Comparison of propranolol therapeutic effects versus placebo on symptom provocation state in traumatized subjects with and without posttraumatic stress disorder

  34 days

• Comparison of activated neuronal networks when a patient remember a pleasant , unpleasant or traumatic event

  34 days

• Comparison of emotional status of traumatized subjects with and without posttraumatic stress disorder

  34 days

Study Arms (4)

1

ACTIVE COMPARATOR

Post-traumatic stress disorder patient receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

Drug: AVLOCARDYL

2

PLACEBO COMPARATOR

Post-traumatic stress disorder receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

Drug: Placebo

3

ACTIVE COMPARATOR

Controls receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

Drug: AVLOCARDYL

4

PLACEBO COMPARATOR

Controls receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

Drug: Placebo

Interventions

AVLOCARDYL DRUG

A grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

1

Placebo DRUG

A grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of French mother language
• Right-handed patients
• Signature of the consent
• Patients:
• Patients whose diagnosis of PTSD according to the criteria of the DSM IV-TR is established
• PTSD whose evolution is not chronic
• Established PTSD : Symptoms presents for at least 1 month
• PTSD consecutive to a unique traumatic event
• Controls :
• The healthy controls will have sudden a traumatism of the same nature or the nature comparable to that of the patients suffering from PTSD, but they will not have developed pathology
• Subjects having undergone a traumatism dating less than 3 months
• Examples of traumatic events: aggression, accident of the public highway, the occupational accident

You may not qualify if:

• The PTSD consecutive to several traumatic events
• Patients treated by a substance crossing the blood-brain barrier (with the exception of the antidepressants of the family of the ISRS which can be indicated in the treatment of PTSD)
• Histories of epilepsy or significant loss of consciousness of any origin, including post-traumatic
• Any psychiatric or somatic significant pathology
• The psychiatric histories in particular of suicide attempt
• The pregnant or breast-feeding women
• Contraindications in the propanolol
• Consumption of psychoactive drugs detected in urines
• Excessive alcohol consumption
• The persons not being capable of understanding or of reading the information describing the study
• The patients refusing to sign the form of consent of participation for the study
• The left-handed or ambidextrous patients
• The patients without the general regime of the health insurance
• The patients under guardianship or incapable major
• Contraindication in the practice of a MRI

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint-Antoine Hospital, Psychiatriy unit

Paris, Île-de-France Region, 75012, France

Location

Related Publications (20)

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• Przybyslawski J, Roullet P, Sara SJ. Attenuation of emotional and nonemotional memories after their reactivation: role of beta adrenergic receptors. J Neurosci. 1999 Aug 1;19(15):6623-8. doi: 10.1523/JNEUROSCI.19-15-06623.1999.

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Emotional Regulation

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Charles-Siegfried Peretti, MD, PhD

  Saint-Antoine hospital, Psychiatry unit, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: November 11, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 26, 2012

Record last verified: 2012-02

Locations

FR (1)