NCT01243658

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

10.3 years

First QC Date

November 17, 2010

Last Update Submit

November 2, 2022

Conditions

Effects of Oxytocin on Borderline Personality DisorderBorderline Personality Disorder

Keywords

OxytocinBPDBorderline

Outcome Measures

Primary Outcomes (1)

  • BPD Symptoms

    BPD Symptoms

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo

Other: placebo

Interventions

OxytocinDRUG

Oxytocin

Oxytocin
placeboOTHER

placebo

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert-Ludwigs-Universität-Freiburg

Freiburg im Breisgau, Baden-Würtemberg, 79104, Germany

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Markus Heinrichs, Prof. Dr.

    Institut für Psychologie der Univeristät Freiburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Markus Heinrichs

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 18, 2010

Study Start

January 1, 2011

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

DE(1)