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Clinical Trials/EUCTR2007-006561-32-DE
EUCTR2007-006561-32-DE
Active, not recruiting
Not Applicable

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

WL University Hospital Bochum0 sitesSeptember 8, 2009
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DrugsSyntocinon-Spray

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
WL University Hospital Bochum
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 8, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
WL University Hospital Bochum

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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