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The effect of oxytocin on prosocial behavior.

The effect of oxytocin on prosocial behavior in social anxiety disorder.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20361
Enrollment
126
Registered
2012-10-22
Start date
2013-01-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder Social Phobia Sociale angststoornis Sociale fobie

Interventions

Treatment will consist of an oxytocin or placebo inhalation. Oxytocin (Syntocinon®) will be administered intranasally. This neuropeptide crosses the bloodbrain barrier reliably after intranasal admini
Heinrichs & Domes, 2008). As in previous studies (see Heinrichs, 2000
Heinrichs & Domes, 2008), the spray will be administered 45 minutes before the onset of the social task. Each administration will consist of three inhalations of the spray into each nostril, with a ti

Sponsors

Maastricht University Faculty of Psychology and Neuroscience Department of Clinical Psychological Science
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group 1: Patients with SAD: 1. Meet the diagnostic criteria of a SAD according to the DSM IV as first diagnosis; 2. Age between 18 and 60 years; 3. IQ above 80; 4. Able to read and write in Dutch; 5. Free of medication, except for hormonal contraceptives. In case of use of benzodiazepine or beta-blockers patients are only included if they refrain from this medication on the testing day; 6. Women free of contraceptives are assessed during the mid-luteal phase of their menstrual cycle. Group 2: Clinical control group: 1. Meet the diagnostic criteria of an anxiety disorder, except SAD, according to the DSM IV as first diagnosis; 2. Age between 18 and 60 years; 3. IQ above 80; 4. Able to read and write in Dutch; 5. Free of medication, except for hormonal contraceptives. In case of use of benzodiazepine or beta-blockers patients are only included if they refrain from this medication on the testing day; 6. Women free of contraceptives are assessed during the mid-luteal phase of their menstrual cycle. Group 3: Healthy control group: 1. Age between 18 and 60 years; 2. IQ above 80; 3. Able to read and write in Dutch; 4. Free of medication, except for hormonal contraceptives. In case of use of benzodiazepine or beta-blockers patients are only included if they refrain from this medication on the testing day; 5. Women free of contraceptives are assessed during the mid-luteal phase of their menstrual cycle.

Exclusion criteria

Exclusion criteria: Group 1: Patients with SAD: 1. Women: pregnancy or breastfeeding; 2. Acute or chronic nasal diseases or obstruction; 3. Major medical condition; 4. Habitual use of anxiolytic medication such as benzodiazepines, SSRI’s, TCA’s, or antipsychotic medication. In case of incidental use of benzodiazepines or betablockers participants are asked to refrain from this medication at the testing day; 5. Acute psychotic complaints, risk for suicide or automutilation; 6. Dependent on alcohol or drugs. Group 2: Clinical control group: 1. A first or comorbid diagnosis of SAD according to the DSM IV; 2. Women: pregnancy or breastfeeding; 3. Acute or chronic nasal diseases or obstruction; 4. Major medical condition; 5. Habitual use of anxiolytic medication such as benzodiazepines, SSRI’s, TCA’s, or antipsychotic medication. In case of incidental use of benzodiazepines or betablockers participants are asked to refrain from this medication at the testing day; 6. Acute psychotic complaints, risk for suicide or automutilation; 7. Dependent on alcohol or drugs. Group 3: Healthy control group: 1. A current or past diagnosis of any anxiety disorder (including SAD) according to the DSM IV; 2. Women: pregnancy or breastfeeding; 3. Acute or chronic nasal diseases or obstruction; 4. Major medical condition; 5. Habitual use of anxiolytic medication such as benzodiazepines, SSRI’s, TCA’s, or antipsychotic medication. In case of incidental use of benzodiazepines or betablockers participants are asked to refrain from this medication at the testing day; 6. Acute psychotic complaints, risk for suicide or automutilation; 7. Dependent on alcohol or drugs.

Design outcomes

Primary

MeasureTime frame
This research project examines the extent to which administering oxytocin improves specific social bonding behaviors (i.e., reciprocal self-disclosure and mimicry) and likeability and reduces social anxiety in SAD patients in comparison to a clinical and healthy control group. To asses social bonding behaviors of the participants the participants conduct a 15-minutes social interaction with a trained confederate. Trained video-observers rate at several time-points the level of self-disclosure responses and amount of mimicked behavior and likeability of the participants. Heart rate and self-report of social anxiety at several time-points during the task are used to assess anxiety responses of the participants.

Secondary

MeasureTime frame
1. We will examine whether SAD patients are less liked at first sight compared to a clinical and healthy control group. This likeability assessment will be conducted prior to the oxytocin inhalation and consist of a video-observation of the moment of entering the laboratory and a picture taken of the participants after entrance. Moreover, participants are asked to bring along three pictures. One in which they are about 4 years of age, a recent picture of themselves and the picture of their identification card (ID) or passport. The video-observation and the pictures will be rated on likeability, attractiveness and safety behaviors by independent raters; 2. We will investigate whether altruistic punishment in a social and non-social condition of the UG differs between SAD patients, clinical and healthy controls and whether a deviant decision-making can be ameliorated by an intranasal oxytocin administration. To measure altruistic punishment, all participants will play the UG as a responder where they either can accept or reject a split of money offered by a putative human player or a computer. The number of rejected unfair offers will be registered as punishment rate. Additionally, all participants will complete a short delayed discounting task measuring impulsivity as an important confound of altruistic punishment. In the delayed discounting task participants have to make hypothetical decision whether they would accept a small immediate or a larger delayed monetary reward.

Contacts

Public ContactM.J. Voncken

Maastricht University Faculty of Psychology and Neuroscience Department of Clinical Psychological Science PO Box 616

m.voncken@maastrichtuniversity.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)