Effects of Oxytocin on Borderline Personality DisorderNCT01243658
"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
A study testing Oxytocin in people with Effects of Oxytocin on Borderline Personality Disorder and Borderline Personality Disorder, run by Prof. Dr. Markus Heinrichs at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Effects of Oxytocin on Borderline Personality Disorder, Borderline Personality Disorder
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- chronic or acute somatic health problems
- Schizophrenia
- Bipolar affective disorder
- pregnancy
- breast feeding
- neurological disorder
- allergy to antidegradants
Trial locations and contacts
1 site in 1 country.
Germany1 site
Albert-Ludwigs-Universität-Freiburg
Freiburg im Breisgau, Baden-Würtemberg, 79104
About this study
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.
- Being tested
- Oxytocin, placebo
- Keywords
- Oxytocin, BPD, Borderline
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytocin Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPD Symptoms
Measured: BPD Symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2021
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Oxytocin on Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Markus Heinrichs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Markus Heinrichs, University of Freiburg
- Investigators
- Markus Heinrichs, Prof. Dr., Study director, Institut für Psychologie der Univeristät Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243658
- Sponsor's protocol ID
- OX02
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2010
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effects of Oxytocin on Patients With Borderline Personality Disorder"
- ClinicalTrials.gov ID
- NCT01243658
- Acronym / sponsor ID
- OX02
- Keywords
- Oxytocin, BPD, Borderline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Prof. Dr. Markus HeinrichsUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinOxytocin |
| Placebo | Placebo comparator | Other: placeboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- chronic or acute somatic health problems
- Schizophrenia
- Bipolar affective disorder
- pregnancy
- breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinOxytocin | Drug | Oxytocin |
| placeboplacebo | Other | Placebo |
Primary outcome
BPD Symptoms
Time frame: BPD Symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Heinrichs, Prof. Dr. study director
Institut für Psychologie der Univeristät Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Effects of Oxytocin on Borderline Personality Disorder and Borderline Personality Disorder, run by Prof. Dr. Markus Heinrichs at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BPD Symptoms (time frame: BPD Symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.