E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ICD-10 F60.3 Emotionally unstable personality disorder Two types may be distinguished: the impulsive type, characterized by emotional instability and lack of impulse control, and the borderline type, characterized in addition by disturbances in self-image, aims, and internal preferences, by chronic feelings of emptiness, by intense and unstable interpersonal relationships, self-destructive behaviour, including suicide gestures and attempts. Clinical control group: major depression (ICD-10 F33) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006034 |
E.1.2 | Term | Borderline personality disorder |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057840 |
E.1.2 | Term | Major depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
Main objective of the trial is to examine if oxytocin, compared to placebo shows any additional effect on the therapy achievements (outcome) of patients with borderline personality disorder, who receive an in-patient standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)). |
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E.2.2 | Secondary objectives of the trial |
Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder. Comparison of the effects of Oxytocin on patients with BPD and major depression.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Borderline personality disorder or major depression (clinical control group) - 18 - 50 years of age - Mini Mental Status Test > 27 (capacity to consent) |
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E.4 | Principal exclusion criteria |
- chronic or acute somatic health problems - Schizophrenia - Bipolar affective disorder - pregnancy - neurological disorder - allergy to antidegradants |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Symptom severity (Borderline-Symtom-List, Bohus et al., 2007) - Number of criteria in DSM-IV - Severity of depression (Beck-Depression-Inventory, Hautzinger et al., 1994) - Frequency of self-injury - Dropout (early therapy termination)
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 |
Combination of a standardized behavioral therapy program with substance administration (Oxytocin). |
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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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
clinical control group of patients with major depression. |
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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
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see protocol: 9. Zeitplan & 6.3 Behandlungsabbruch/Studienabbruch
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
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 | 0 |
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 |