Schizophrenia, bipolar disorder, major depression, personality disorder
Conditions
Interventions
Trade Name: Syntocinon-Spray
Product Name: Oxytocin
Pharmaceutical Form: Nasal spray*
INN or Proposed INN: OXYTOCIN
CAS Number: 50566
Concentration unit: IU/ml international unit(s)/millilitre
Concent
Sponsors
LWL University Hospital Bochum
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effects of a single dose of oxytocin on the perception and interpretation of social stimuli, including emotion recognition and the ability to infer the mental states of others.;Secondary Objective: Evaluation of the effects of a single dose of oxytocin on psychopathology, as assessed by the Brief Psychiatric Rating Scale (BPRS) with video analysis of non-verbal behavior, the Montgomery-Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), Toronto Alexithymia Scale (TAS-20), Childhood Trauma Questionnaire (CTQ), Beck Cognitive Insight Scale (BCIS) and the Temperament Character Inventory (TCI), as well as on event-related potentials (LDAEP) and oxytocin concentration.;Primary end point(s): - improvement of perception and interpretation of emotional stimuli - improvement of behaviour with regard to the perception of unfairness - improvement of mental perspective-taking | — |
Countries
Germany
Outcome results
None listed