Posttraumatic Stress DisorderPhase 3VIVITRAUNCT01239173
Emotional Memory Reactivation in Posttraumatic Stress Disorder
A Phase 3 study testing AVLOCARDYL in people with Posttraumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- AVLOCARDYL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- The patients who will not be capable of supplying a documentary evidence of identity the day of the inclusion
- Contraindication in the practice of a MRI
- The patients or the controls refusing the medical and psychiatric balance assessment of screening cannot participate in the study
- Strong probability of not compliance to the protocol or of abandonment in the course of study
- Taking of a speechless medicine, in particular beta-blocking
- Participating in phase of exclusion from a previous study
Trial locations and contacts
1 site in 1 country.
France1 site
Saint-Antoine Hospital, Psychiatriy unit
Paris, Île-de-France Region, 75012
About this study
Official title: Reliving the Traumatic Event in Posttraumatic Stress Disorder: An Emotional Memory Reactivation Pathology? An fMRI Study
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.
Read the detailed description
Post-traumatic stress disorder (PTSD) is a type of anxiety disorder that's triggered by an extremely traumatic event. Traumatic events that may trigger PTSD include violent personal assaults, accidents, natural or human-caused disasters, or military combat. Converging lines of evidence have implicated the amygdala in the pathophysiology of posttraumatic stress disorder.
Initially based on animal studies, the idea that memory for emotional material in humans is modulated by the noradrenergic system and by the amygdala, has received a strong support over the last decade. Evidence mainly comes from studies investigating the effect of emotion on encoding processes (Mc GAUGH, 2000). In that view, propranolol has been used somewhat successfully shortly after trauma to reduce the development of PTSD symptoms (Pitman et al., 2002; VAIVA et al., 2003). As already mentioned, "reconsolidation" studies developed in rats provide treatment strategies that can be used long after PTSD induction. Recent evidence indicates that consolidated long-term memory in human can also be influenced by events delivered after memory reactivation (Walker et al., 2003; HUPBACH et al., 2007), suggesting that human memory can be retroactively altered by treatments delivered in conjunction with memory reactivation. This seems to be confirmed by an as yet unpublished human based study that suggests that propranolol may impair reconsolidation of conditioned fear-response (Miller et al., 2004) 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. One Functional magnetic resonance imaging (fMRI) will be performed (week 1) in 32 patients with PTSD and 32 controls (exposure to a traumatic event without PTSD) to examine amygdala activation during a provocation state.
One half of the patients with PTSD and one half of the controls will receive propranolol prior the fMRI under double blind condition.
In addition, a cognitive test battery will be performed (screening, week 0, 1, 2) before the fRMI acquisition and at follow up visits.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- AVLOCARDYL, Placebo
- Keywords
- Posttraumatic stress disorder, functional Magnetic Resonance Imaging, Amygdala, emotion regulation, memory
- Medical subject headings
- Stress Disorders, Post-Traumatic, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVLOCARDYLDrug
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
PlaceboDrug
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
AVLOCARDYLDrug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
| 3 | Active comparator | Controls receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI Receives: Drug: AVLOCARDYL |
| 4 | Placebo comparator | Controls receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder
Measured: 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
Measured: 34 days
Comparison of activated neuronal networks when a patient remember a pleasant , unpleasant or traumatic event
Measured: 34 days
Comparison of emotional status of traumatized subjects with and without posttraumatic stress disorder
Measured: 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionFeb 2012
Why it stopped: Study stopped by promoter for lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles-Siegfried Peretti, MD, PhD, Principal investigator, Saint-Antoine hospital, Psychiatry unit, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239173
- Sponsor's protocol ID
- AOM06075/ P060226
- Acronym
- VIVITRAU
- Status last verified
- Feb 2012
- First submitted
- 25 Oct 2010
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adler SA, Wilk A, Rovee-Collier C. Reinstatement versus reactivation effects on active memory in infants. J Exp Child Psychol. 2000 Feb;75(2):93-115. doi: 10.1006/jecp.1999.2531.
PubMed 10620375Blanchard EB, Hickling EJ, Taylor AE, Forneris CA, Loos W, Jaccard J. Effects of varying scoring rules of the Clinician-Administered PTSD Scale (CAPS) for the diagnosis of post-traumatic stress disorder in motor vehicle accident victims. Behav Res Ther. 1995 May;33(4):471-5. doi: 10.1016/0005-7967(94)00064-q.
PubMed 7755537Botreau F, El Massioui N, Cheruel F, Gisquet-Verrier P. Effects of medial prefrontal cortex and dorsal striatum lesions on retrieval processes in rats. Neuroscience. 2004;129(3):539-53. doi: 10.1016/j.neuroscience.2004.08.032.
PubMed 15541876Boujabit M, Bontempi B, Destrade C, Gisquet-Verrier P. Exposure to a retrieval cue in rats induces changes in regional brain glucose metabolism in the amygdala and other related brain structures. Neurobiol Learn Mem. 2003 Jan;79(1):57-71. doi: 10.1016/s1074-7427(02)00010-2.
PubMed 12482680Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.
PubMed 17588604Dirikx T, Hermans D, Vansteenwegen D, Baeyens F, Eelen P. Reinstatement of extinguished conditioned responses and negative stimulus valence as a pathway to return of fear in humans. Learn Mem. 2004 Sep-Oct;11(5):549-54. doi: 10.1101/lm.78004.
PubMed 15466307Ferry B, McGaugh JL. Clenbuterol administration into the basolateral amygdala post-training enhances retention in an inhibitory avoidance task. Neurobiol Learn Mem. 1999 Jul;72(1):8-12. doi: 10.1006/nlme.1998.3904.
PubMed 10371711Giles J. Beta-blockers tackle memories of horror. Nature. 2005 Jul 28;436(7050):448-9. doi: 10.1038/436448a. No abstract available.
PubMed 16049437Gisquet-Verrier P, Botreau F, Venero C, Sandi C. Exposure to retrieval cues improves retention performance and induces changes in ACTH and corticosterone release. Psychoneuroendocrinology. 2004 May;29(4):529-56. doi: 10.1016/s0306-4530(03)00085-4.
PubMed 14749097Herz RS. Are odors the best cues to memory? A cross-modal comparison of associative memory stimuli. Ann N Y Acad Sci. 1998 Nov 30;855:670-4. doi: 10.1111/j.1749-6632.1998.tb10643.x.
PubMed 9929669Maheu FS, Joober R, Beaulieu S, Lupien SJ. Differential effects of adrenergic and corticosteroid hormonal systems on human short- and long-term declarative memory for emotionally arousing material. Behav Neurosci. 2004 Apr;118(2):420-8. doi: 10.1037/0735-7044.118.2.420.
PubMed 15113269Przybyslawski 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.
PubMed 10414990Quirarte GL, Roozendaal B, McGaugh JL. Glucocorticoid enhancement of memory storage involves noradrenergic activation in the basolateral amygdala. Proc Natl Acad Sci U S A. 1997 Dec 9;94(25):14048-53. doi: 10.1073/pnas.94.25.14048.
PubMed 9391150Sara SJ. Retrieval and reconsolidation: toward a neurobiology of remembering. Learn Mem. 2000 Mar-Apr;7(2):73-84. doi: 10.1101/lm.7.2.73. No abstract available.
PubMed 10753974Simson PE, Naylor JC, Gibson B, Schneider AM, Levin D. Dose-sensitive excitation and inhibition of spontaneous amygdala activity by propranolol. Pharmacol Biochem Behav. 2001 May-Jun;69(1-2):85-92. doi: 10.1016/s0091-3057(01)00503-2.
PubMed 11420072
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliving the Traumatic Event in Posttraumatic Stress Disorder: An Emotional Memory Reactivation Pathology? An fMRI Study
- ClinicalTrials.gov ID
- NCT01239173
- Acronym / sponsor ID
- VIVITRAU / AOM06075/ P060226
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic stress disorder, functional Magnetic Resonance Imaging, Amygdala, emotion regulation, memory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped by promoter for lack of inclusion
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-traumatic stress disorder (PTSD) is a type of anxiety disorder that's triggered by an extremely traumatic event. Traumatic events that may trigger PTSD include violent personal assaults, accidents, natural or human-caused disasters, or military combat. Converging lines of evidence have implicated the amygdala in the pathophysiology of posttraumatic stress disorder.
Initially based on animal studies, the idea that memory for emotional material in humans is modulated by the noradrenergic system and by the amygdala, has received a strong support over the last decade. Evidence mainly comes from studies investigating the effect of emotion on encoding processes (Mc GAUGH, 2000). In that view, propranolol has been used somewhat successfully shortly after trauma to reduce the development of PTSD symptoms (Pitman et al., 2002; VAIVA et al., 2003). As already mentioned, "reconsolidation" studies developed in rats provide treatment strategies that can be used long after PTSD induction. Recent evidence indicates that consolidated long-term memory in human can also be influenced by events delivered after memory reactivation (Walker et al., 2003; HUPBACH et al., 2007), suggesting that human memory can be retroactively altered by treatments delivered in conjunction with memory reactivation. This seems to be confirmed by an as yet unpublished human based study that suggests that propranolol may impair reconsolidation of conditioned fear-response (Miller et al., 2004) 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. One Functional magnetic resonance imaging (fMRI) will be performed (week 1) in 32 patients with PTSD and 32 controls (exposure to a traumatic event without PTSD) to examine amygdala activation during a provocation state.
One half of the patients with PTSD and one half of the controls will receive propranolol prior the fMRI under double blind condition.
In addition, a cognitive test battery will be performed (screening, week 0, 1, 2) before the fRMI acquisition and at follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AVLOCARDYLPost-traumatic stress disorder patient receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI |
| 2 | Placebo comparator | Drug: PlaceboPost-traumatic stress disorder receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI |
| 3 | Active comparator | Drug: AVLOCARDYLControls receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI |
| 4 | Placebo comparator | Drug: PlaceboControls receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients of French mother language
- Right-handed patients
- Signature of the consent
- Patients whose diagnosis of PTSD according to the criteria of the DSM IV-TR is established
- PTSD whose evolution is not chronic
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVLOCARDYLA grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI | Drug | 1 |
| PlaceboA grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI | Drug | 2 |
| AVLOCARDYLA grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI | Drug | 3 |
| PlaceboA grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI | Drug | 4 |
Primary outcome
Effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder
Time frame: 34 days
3 secondary outcomes
Comparison of propranolol therapeutic effects versus placebo on symptom provocation state in traumatized subjects with and without posttraumatic stress disorder
Time frame: 34 days
Comparison of activated neuronal networks when a patient remember a pleasant , unpleasant or traumatic event
Time frame: 34 days
Comparison of emotional status of traumatized subjects with and without posttraumatic stress disorder
Time frame: 34 days
Results and safety
The study was stopped early (reason given: Study stopped by promoter for lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
- Background: PubMed 10620375Adler SA, Wilk A, Rovee-Collier C. Reinstatement versus reactivation effects on active memory in infants. J Exp Child Psychol. 2000 Feb;75(2):93-115. doi: 10.1006/jecp.1999.2531.
- Background: PubMed 7755537Blanchard EB, Hickling EJ, Taylor AE, Forneris CA, Loos W, Jaccard J. Effects of varying scoring rules of the Clinician-Administered PTSD Scale (CAPS) for the diagnosis of post-traumatic stress disorder in motor vehicle accident victims. Behav Res Ther. 1995 May;33(4):471-5. doi: 10.1016/0005-7967(94)00064-q.
- Background: PubMed 15541876Botreau F, El Massioui N, Cheruel F, Gisquet-Verrier P. Effects of medial prefrontal cortex and dorsal striatum lesions on retrieval processes in rats. Neuroscience. 2004;129(3):539-53. doi: 10.1016/j.neuroscience.2004.08.032.
- Background: PubMed 12482680Boujabit M, Bontempi B, Destrade C, Gisquet-Verrier P. Exposure to a retrieval cue in rats induces changes in regional brain glucose metabolism in the amygdala and other related brain structures. Neurobiol Learn Mem. 2003 Jan;79(1):57-71. doi: 10.1016/s1074-7427(02)00010-2.
- Background: PubMed 17588604Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.
- Background: PubMed 15466307Dirikx T, Hermans D, Vansteenwegen D, Baeyens F, Eelen P. Reinstatement of extinguished conditioned responses and negative stimulus valence as a pathway to return of fear in humans. Learn Mem. 2004 Sep-Oct;11(5):549-54. doi: 10.1101/lm.78004.
- Background: PubMed 10371711Ferry B, McGaugh JL. Clenbuterol administration into the basolateral amygdala post-training enhances retention in an inhibitory avoidance task. Neurobiol Learn Mem. 1999 Jul;72(1):8-12. doi: 10.1006/nlme.1998.3904.
- Background: PubMed 16049437Giles J. Beta-blockers tackle memories of horror. Nature. 2005 Jul 28;436(7050):448-9. doi: 10.1038/436448a. No abstract available.
- Background: PubMed 14749097Gisquet-Verrier P, Botreau F, Venero C, Sandi C. Exposure to retrieval cues improves retention performance and induces changes in ACTH and corticosterone release. Psychoneuroendocrinology. 2004 May;29(4):529-56. doi: 10.1016/s0306-4530(03)00085-4.
- Background: PubMed 9929669Herz RS. Are odors the best cues to memory? A cross-modal comparison of associative memory stimuli. Ann N Y Acad Sci. 1998 Nov 30;855:670-4. doi: 10.1111/j.1749-6632.1998.tb10643.x.
- Background: PubMed 15113269Maheu FS, Joober R, Beaulieu S, Lupien SJ. Differential effects of adrenergic and corticosteroid hormonal systems on human short- and long-term declarative memory for emotionally arousing material. Behav Neurosci. 2004 Apr;118(2):420-8. doi: 10.1037/0735-7044.118.2.420.
- Background: PubMed 10414990Przybyslawski 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles-Siegfried Peretti, MD, PhD principal investigator
Saint-Antoine hospital, Psychiatry unit, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AVLOCARDYL in people with Posttraumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopped by promoter for lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder (time frame: 34 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01239173, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.