"The Effects of Oxytocin on Patients With Borderline Personality Disorder"

NCT ID: NCT01243658

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Effects of Oxytocin on Borderline Personality Disorder Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxytocin

Oxytocin

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

Interventions

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Oxytocin

Oxytocin

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gender: Both, male and female
* Minimum Age: 18 Years
* Maximum Age: 50 Years
* Borderline personality disorder or major depression (clinical control group)
* Mini Mental Status Test \> 27 (capacity to consent)

Exclusion Criteria

* chronic or acute somatic health problems
* Schizophrenia
* Bipolar affective disorder
* pregnancy
* breast feeding
* neurological disorder
* allergy to antidegradants
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Markus Heinrichs

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Markus Heinrichs

Prof. Dr. Markus Heinrichs

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Markus Heinrichs, Prof. Dr.

Role: STUDY_DIRECTOR

Institut für Psychologie der Univeristät Freiburg

Locations

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Albert-Ludwigs-Universität-Freiburg

Freiburg im Breisgau, Baden-Würtemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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OX02

Identifier Type: -

Identifier Source: org_study_id

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