Borderline Personality DisorderPhase 3NCT00124839
Naltrexone in Borderline Personality Disorder
A Phase 3 study testing Naltrexone in people with Borderline Personality Disorder, run by Central Institute of Mental Health, Mannheim at 5 sites in Germany.
Trial summary
The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesGermany
- Study dates
- Oct 2005to Mar 2008
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- In- and Outpatients:Borderline personality disorder according to the Diagnostic and Statistical Manual for Mental Disorders, 4.Edition (DSM IV)
- DES-(Dissociative Experience Scale)-score: > or equal 18 according to amendment4 (former value according to amendment 2 was > or equal 25).
- Urinary test of opiates negative
- No psychopharmacological treatment for two weeks prior to study (fluoxetine four weeks)
- No Lithium for two months
Who cannot join
- Lifetime diagnosis of psychotic disorder
- Current major depressive disorder (MDD)
- Lifetime diagnosis opioid dependence or current opioid abuse (10 to 7 days prior to study)
- Comedication with opioid analgetics
- Known naltrexone intolerance
- Liver disease
Show all 9Show fewer
- Pregnancy and lactation period
- Other severe medical or neurological diseases
- Simultaneous participation in another study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine
Bad Wiessee, Bavaria, 83707
Dept.of Psychiatry and Psychotherapy , Rheinische Kliniken Köln
Cologne, North Rhine-Westphalia, 51109
Dept. of Psychosomatic Medicine, Central Instiute of Mental Health
Mannheim, Baden-Würtemberg, 68159
Dept.of Psychiatry and Psychotherapy; Center of Neurology
Rostock, Mecklenburg-Vorpommern, 18147
Inntalklinik Simbach am Inn
Simbach, Bavaria, 84359
About this study
Official title: Evaluation of the Efficacy of the Opioid Antagonist Naltrexone on the Incidence and Intensity of Flashbacks and Dissociative States in Patients With Borderline Personality Disorder
The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.
- Conditions
- Borderline Personality Disorder
- Being tested
- Naltrexone
- Keywords
- Dissociation, Flashbacks, Self-injurious behavior
- Medical subject headings
- Borderline Personality Disorder, Dissociative Disorders, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week) Receives: Drug: Naltrexone |
| 2 | Other | Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week) Receives: Drug: Naltrexone |
| 3 | Other | Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week) Receives: Drug: Naltrexone |
| 4 | Other | Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week) Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of dissociative symptoms
Measured: End of 3rd week treatment of naltrexon
Secondary outcomes (4)
Reduction of flashbacks
Measured: End of 3rd week treatment of naltrexone
Reduction of self-injurious behavior
Measured: End of 3rd week treatment of naltrexone
Reduction of psychopathology (depression, anxiety, anger, borderline symptoms)
Measured: End of 3rd week treatment of naltrexone
Safety regarding liver enzyme elevation
Measured: End of 3rd week treatment of naltrexone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startOct 2005
- Primary completionOct 2007
- Study completionMar 2008
Why it stopped: Difficulties in recruiting enough subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Investigators
- Martin Bohus, M.D., Study director, University of Heidelberg, Central Institute of Mental Health Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124839
- Sponsor's protocol ID
- Naltrexon-BPS
- Status last verified
- Apr 2008
- First submitted
- 27 Jul 2005
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmahl C, Bohus M. [Treatment of dissociative symptoms in borderline personality disorder with naltrexone: supplementary comments]. Nervenarzt. 2000 May;71(5):427. doi: 10.1007/s001150050582. No abstract available. German.
PubMed 10846724Bohus MJ, Landwehrmeyer GB, Stiglmayr CE, Limberger MF, Bohme R, Schmahl CG. Naltrexone in the treatment of dissociative symptoms in patients with borderline personality disorder: an open-label trial. J Clin Psychiatry. 1999 Sep;60(9):598-603. doi: 10.4088/jcp.v60n0906.
PubMed 10520978Schmahl C, Stiglmayr C, Bohme R, Bohus M. [Treatment of dissociative symptoms in borderline patients with naltrexone]. Nervenarzt. 1999 Mar;70(3):262-4. doi: 10.1007/s001150050431. German.
PubMed 10231814Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
PubMed 36375174
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Opioid Antagonist Naltrexone on the Incidence and Intensity of Flashbacks and Dissociative States in Patients With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT00124839
- Acronym / sponsor ID
- Naltrexon-BPS
- Conditions
- Borderline Personality Disorder
- Keywords
- Dissociation, Flashbacks, Self-injurious behavior
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting enough subjects
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 28 Jul 2005 (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.
The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: NaltrexoneBlinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week) |
| 2 | Other | Drug: NaltrexoneBlinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week) |
| 3 | Other | Drug: NaltrexoneBlinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week) |
| 4 | Other | Drug: NaltrexoneBlinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In- and Outpatients:Borderline personality disorder according to the Diagnostic and Statistical Manual for Mental Disorders, 4.Edition (DSM IV)
- DES-(Dissociative Experience Scale)-score: > or equal 18 according to amendment4 (former value according to amendment 2 was > or equal 25).
- Urinary test of opiates negative
- No psychopharmacological treatment for two weeks prior to study (fluoxetine four weeks)
- No Lithium for two months
Key exclusion criteria (9 listed)
- Lifetime diagnosis of psychotic disorder
- Current major depressive disorder (MDD)
- Lifetime diagnosis opioid dependence or current opioid abuse (10 to 7 days prior to study)
- Comedication with opioid analgetics
- Known naltrexone intolerance
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 |
|---|---|---|
| NaltrexoneDaily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone | Drug | 1, 2, 3, 4 |
Primary outcome
Reduction of dissociative symptoms
Time frame: End of 3rd week treatment of naltrexon
4 secondary outcomes
Reduction of flashbacks
Time frame: End of 3rd week treatment of naltrexone
Reduction of self-injurious behavior
Time frame: End of 3rd week treatment of naltrexone
Reduction of psychopathology (depression, anxiety, anger, borderline symptoms)
Time frame: End of 3rd week treatment of naltrexone
Safety regarding liver enzyme elevation
Time frame: End of 3rd week treatment of naltrexone
Results and safety
The study was stopped early (reason given: Difficulties in recruiting enough subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
- Background: PubMed 10846724Schmahl C, Bohus M. [Treatment of dissociative symptoms in borderline personality disorder with naltrexone: supplementary comments]. Nervenarzt. 2000 May;71(5):427. doi: 10.1007/s001150050582. No abstract available. German.
- Background: PubMed 10520978Bohus MJ, Landwehrmeyer GB, Stiglmayr CE, Limberger MF, Bohme R, Schmahl CG. Naltrexone in the treatment of dissociative symptoms in patients with borderline personality disorder: an open-label trial. J Clin Psychiatry. 1999 Sep;60(9):598-603. doi: 10.4088/jcp.v60n0906.
- Background: PubMed 10231814Schmahl C, Stiglmayr C, Bohme R, Bohus M. [Treatment of dissociative symptoms in borderline patients with naltrexone]. Nervenarzt. 1999 Mar;70(3):262-4. doi: 10.1007/s001150050431. German.
- Derived from this study: PubMed 36375174Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
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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.
Martin Bohus, M.D. study director
University of Heidelberg, Central Institute of Mental Health Mannheim
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naltrexone in people with Borderline Personality Disorder, run by Central Institute of Mental Health, Mannheim at 5 sites 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 9 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: stopped early, as of the sponsor's last update on 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting enough subjects). Results are not available in the source record.
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?
Reduction of dissociative symptoms (time frame: End of 3rd week treatment of naltrexon). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124839, which also lists 4 linked publications.
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 15 Apr 2008.