Trial document

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DRKS-ID: DRKS00000604

Trial Description

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Title

Effects of oxytocin on patients with Borderline Personality Disorder

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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)).
Secondary objectives :
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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Brief Summary in Scientific Language

RCT. Two substudies (clinical and experimental). 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)).
Secondary objectives :
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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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00000604
Date of Registration in DRKS: 2010/11/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 307/10, Ethik-Kommission der Albert-Ludwig-Universität Freiburg

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Secondary IDs

EudraCT-Number: 2010-020956-69
BfArM-No.: 4036755

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Health Condition or Problem studied

ICD10: F60.31 - [generalization F60.3: Emotionally unstable personality disorder]
ICD10: F33.1 - Recurrent depressive disorder, current episode moderate

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Interventions/Observational Groups

Arm 1: Syntocinon-Spray (Novartis)

active substance: Oxytocin

4x singel dose of 24 I.U. (before the experiments)

For the period of 8 weeks 3 x a day 20 I.U. (max. daily dose of 60 I.E.)
Arm 2: Placebo-Spray

same dose as arm 1

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Double or multiple blind
Who is blinded: [---]*
Control: Placebo
Purpose: Other
Assignment: Factorial
Phase: N/A
Off-label Drug use: [---]*

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Primary Outcome

- 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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Secondary Outcome

- Emotion recognition
- social trust
- rejection sensitivity
- tension
- interpersonel problems
- impulsivity
- disosiation
- mood
- eye-tracking
- cortisol
- heart beat frequence

14 process messure Points

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2010/12/01
Target Sample Size: 250
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 50 Years

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Additional 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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Exclusion Criteria

- chronic or acute somatic health problems
- Schizophrenia
- Bipolar affective disorder
- pregnancy
- breast feeding
- neurological disorder
- allergy to antidegradants

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Addresses

Primary Sponsor
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- Psychologisches Institut der Albert-Ludwigs-Universität Freiburg Abteilung für Biologische und Differentielle Psychologie
- Mr. Prof. Dr. Markus Heinrichs
- Stefan-Meier-Str. 8
- 79104 Freiburg
- Germany
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- Telephone: 0761-203-3029
- Fax: 0761-203-3023
- E-mail: heinrichs at psychologie.uni-freiburg.de
- URL: http://www.psychologie.uni-freiburg.de/
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Contact for Scientific Queries
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- Psychologisches Institut der Albert-Ludwigs-Universität Freiburg Abteilung für Biologische und Differentielle Psychologie
- Ms. Dipl.-Psych. Nicole Ower
- Stefan-Meier-Strasse 8
- 79104 Freibrug
- Germany
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- Telephone: 0761-203-97743
- Fax: 0761-203-3023
- E-mail: Nicole.ower at psychologie.uni-freiburg.de
- URL: http://www.psychologie.uni-freiburg.de/
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Contact for Public Queries
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- Psychologisches Institut der Albert-Ludwigs-Universität Freiburg Abteilung für Biologische und Differentielle Psychologie
- Ms. Dipl.-Psych. Nicole Ower
- Stefan-Meier-Str. 8
- 79104 Freibrug
- Germany
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- Telephone: 0761-20397743
- Fax: 0761-203-3023
- E-mail: Nicole.ower at psychologie.uni-freiburg.de
- URL: http://www.psychologie.uni-freiburg.de/
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Sources of Monetary or Material Support

Institutional budget , no external funding (budget of sponsor/PI)
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- Psychologisches Institut der Albert-Ludwigs-Universität Freiburg Abteilung für Biologische und Differentielle Psychologie
- Mr. Prof. Dr. Markus Heinrichs
- Stefan-Meier-Str. 8
- 79104 Freiburg
- Germany
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- Telephone: 0761-203-3029
- Fax: 0761-203-3023
- E-mail: heinrichs at psychologie.uni-freiburg.de
- URL: http://www.psychologie.uni-freiburg.de/
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Status

Recruitment Status: Recruiting planned
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.