Effects of intranasal application of oxytocin on empathy and mentalising in patients with psychotic disorders and severe personality disorders

• Conditions: Schizophrenia, bipolar disorder, major depression, personality disorder

• Registration Number: EUCTR2007-006561-32-DE
• Lead Sponsor: WL University Hospital Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-08
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

· male or female patients, 18 to 45 years of age
· diagnosis of schizophrenia, bipolar disorder, major depression or personality disorder, as defined using research diagnostic criteria according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
· healthy male and female controls, age 18 to 45 years
· participants must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol
· participants must be able to understand the nature of the study and give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· patients in whom the application of a single dose of oxytocin or placebo is relatively or absolutely clinically contraindicated
· patients who smoke
· patients who have received an experimental drug or used an experimental medical device for any indication within 30 days prior to Visit 1
· DSM-IV diagnosis of substance dependence
· female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
· prolactin level > 200 ng/ml at baseline
· clinically significant ECG abnormalities at screening
· patients with acute, serious, or unstable medical conditions
· employees of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, as well as family members of the employees or the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified