"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
This study is currently recruiting participants.
Verified April 2012 by University of Freiburg
Sponsor:
Prof. Dr. Markus Heinrichs
Information provided by (Responsible Party):
Prof. Dr. Markus Heinrichs, University of Freiburg
ClinicalTrials.gov Identifier:
NCT01243658
First received: November 17, 2010
Last updated: April 26, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | November 17, 2010 | ||||
| Last Updated Date | April 26, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
BPS Symptoms [ Time Frame: BPS Symptoms ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01243658 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | "The Effects of Oxytocin on Patients With Borderline Personality Disorder" | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Effects of Oxytocin on Borderline Personality Disorder. | ||||
| Intervention ICMJE | Drug: Oxytocin
Oxytocin
Other Name: Oxytocin |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | October 2013 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01243658 | ||||
| Other Study ID Numbers ICMJE | OX02 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Prof. Dr. Markus Heinrichs, University of Freiburg | ||||
| Study Sponsor ICMJE | Prof. Dr. Markus Heinrichs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Freiburg | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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