E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia, bipolar disorder, major depression, personality disorder |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
- successful completion of the study - safety doubts |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |