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

Prof. Dr. Markus Heinrichs

Status: Completed

Conditions: Borderline Personality Disorder; Effects of Oxytocin on Borderline Personality Disorder

Treatments: Other: placebo; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01243658

OX02

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups, including a placebo group

Oxytocin

Experimental group

Description:

Oxytocin

Treatment:

Drug: Oxytocin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: placebo