Objective: This study hypothesizes that an oxytocin inhalation will increase prosocial behavior and reduces social anxiety during social interaction specifically in patients with SAD in comparison to a clinical and healthy control group
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Videoraters will rate the amount of two social bonding behaviors, reciprocal
self-disclosure and mimicry, and the likeability of the participants at several
time-points during a 15-minutes social interaction. Participant rate their
level of subjective social anxiety at several time-points during this social
interaction.
Secondary outcome
Furthermore, it is examined whether SAD patients are less liked at first sight
compared to a clinical and healthy control group. Last, the impact of SAD and
possible oxytocin effects on economic decision-making are assessed by two short
computerized tasks.
Background summary
Rationale: Patients with social anxiety disorder (SAD) are characterized by a
persistent, excessive anxiety during social interactions. Recent studies
indicate that they show deficits in prosocial behaviors that are essential for
the development of friendships such as reciprocal self-disclosure (sharing of
personal information) and mimicry (subconscious mimicking of others postures).
SAD is one of the most prevalent anxiety disorders and has a great impact on
quality of life. Recently is has been speculated that the hormone oxytocin
plays an important role in the etiology and maintenance of SAD and in future
may even develop into a medicine for treatment of this disabling disorder.
Oxytocin is originally known for its role during labor and breastfeeding.
Moreover, it plays an important role in the mother-child attachment. Recent
studies show that this hormone also stimulates prosocial behavior in both men
as women. In addition it reduces anxiety responses. Therefore, it has been
speculated that oxytocin could have a positive effect for patients with SAD. It
would not only reduce their social anxiety but also stimulate pro social
behavior.
Study objective
Objective: This study hypothesizes that an oxytocin inhalation will increase
prosocial behavior and reduces social anxiety during social interaction
specifically in patients with SAD in comparison to a clinical and healthy
control group
Study design
Study design: This is a double-blind randomized placebo controlled experimental
study.
Intervention
Half of the participants receive a 24 IU oxytocin inhalation and the other half
with receive a placebo inhalation.
Study burden and risks
The assessment will take 4 hours. This includes an interview concerning
psychopathological complaints, various questionnaires and a 15-minutes social
interaction task with a confederate and two short computerized economic
decision-making tasks. Participants receive either a placebo or an oxytocin
inhalation. Oxytocin inhaltion are widely studied and are well tolerated.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Fulfill the criteria of Social Anxiety Disorder or any other Anxiety Disorder
Age between 18 and 60 years
IQ above 80
Able to read and write in Dutch
Free of medication, except hormonal contraceptives
Absence of major medical, endocrine and neurological condition
Exclusion criteria
Women: pregnancy or breastfeeding
Acute psychotic complaints, risk for suicide or automutulation
Dependent on alcohol or drugs
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-004284-75-NL |
| Other | is nog in behandeling |
| CCMO | NL38026.068.12 |
| OMON | NL-OMON20361 |