Our aim is to test whether disrupting the process of fear memory reconsolidation is an effective as well as efficient intervention for patients with panic disorder. A secondary aim is to test whether the expected reduction in panic attacks and…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Individual scores on the Panic Disorder Severity Scale.
Presence of panic disorder according to DSM V criteria
Secondary outcome
Individual scores on the Panic Appraisal Inventory, Mobility Inventory, Body
Sensations Questionnaire, and Agoraphobic Cognitions Questionnaire will be used
as secondary study parameters. In addition, willingness to inhale 35% CO2 is
used as a secondary study parameter.
Background summary
Several epidemiological studies confirm that anxiety disorders as a group are
the most impairing and prevalent of chronic diseases in Europe and the United
States. Cognitive behavioral therapy for anxiety disorders is the treatment of
choice in clinical practice. However, CBT only eliminates fearful responding,
leaving the original fear memory intact as is substantiated by the high
percentages of relapse (i.e., up to 60%), even after apparently successful
treatment. At the turn of this century a major breakthrough in neuroscience was
achieved with the discovery that fear memory is not inevitably permanent, but
can change when retrieved. Nader and colleagues demonstrated in rats that upon
retrieval, consolidated memories may return to a labile state, requiring de
novo protein synthesis for restabilization: a process referred to as 'memory
reconsolidation' that offers a window of opportunity to permanently weaken fear
memories with amnesic agents. Disrupting the process of memory reconsolidation
by amnesic agents (e.g., the noradrenergic beta-blocker propranolol HCl)
recently progressed from animals to healthy participants. The current study
addresses the question whether disrupting fear memory reconsolidation by
propranolol is effective in patients with panic disorder.
Study objective
Our aim is to test whether disrupting the process of fear memory
reconsolidation is an effective as well as efficient intervention for patients
with panic disorder. A secondary aim is to test whether the expected reduction
in panic attacks and concomitant anxiety symptoms persists over time.
Study design
Double-blind (pill) and single-blind (gas inhalation) placebo-controlled.
Intervention
One of the following:
1. 35% CO2-enriched air inhalation followed by the administration of 40 mg
propranolol.
2. A placebo-inhalation followed by the administration of 40 mg
propranolol.
3. 35% CO2-enriched air inhalation followed by the administration of 40 mg
pill placebo.
Study burden and risks
Participants are receiving a short treatment that is expected to diminish their
panic symptoms. CO2-inhalation causes symptoms of arousal and fear, but these
are of short duration and are harmless. Furthermore, there are no long-term
effects of this inhalation. Based on the Summary of Product Characteristics we
expect that propranolol will be well tolerated and do not anticipate any
serious adverse events.
Nieuwe Achtergracht 129
Amsterdam 1001 NK
NL
Nieuwe Achtergracht 129
Amsterdam 1001 NK
NL
Listed location countries
Age
Inclusion criteria
A primary diagnosis of panic disorder according to DSM-V.
Exclusion criteria
* other relevant treatment for panic disorder at the time of study - e.g., CBT
* diagnosis of psychosis
* use of psychotropic medication
* A current state of asthma or COPD, which necessitates medication use
* history of respiratory diseases (asthma or COPD in the past does not lead to exclusion)
* history of cardiovascular diseases or irregular heartbeat
* history of cerebrovascular diseases
* history of severe allergic reactions to propranolol, which necessitated hospitalisation
* cerebral aneurysm among first-degree relatives
* Heart rate < 60. If heart rate is between 55 and 60 bpm, but exceeds 60 bpm after a minute of moderate physical activity (2-step test), the participant can be included. A heart rate of <50 in participants who spend 7 hours or more per week engaged in physical exercise will be the resting heart rate limit. A heart rate of <50 will lead to immediate exclusion (no 2-step test).
* BP < 100/60 or BP > 180/100
* epilepsy
* any medication contra-indicative of the use of propranolol
* pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005338-23-NL |
| ClinicalTrials.gov | NCT:NCT02631694 |
| CCMO | NL54871.018.15 |