Borderline Personality DisorderPhase 2NCT01133301
Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
A Phase 2 study testing Naltrexone in people with Borderline Personality Disorder and Dissociation, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy as an antidissociative agent by using a double-blind randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Borderline Personality Disorder, Dissociation
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 1998to Oct 2001
- Phase
- Phase 2
- 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
- Diagnosis of BPD according to DSM-IV
- DES score ≥ 18
- Female gender
- Age between 18 and 50 years
Who cannot join
- Lifetime diagnosis of schizophrenia, psychotic or delusional disorder
- Current major depressive episode
- Lifetime diagnosis opioid dependence
- Current diagnosis opioid abuse
- Liver insufficiency or hepatitis
- Other major medical or neurological medical condition
Show all 10Show fewer
- Pregnancy or lactation
- Psychotropic medication within two weeks before and during the trial (fluoxetine 4 weeks, lithium 8 weeks)
- Concomitant treatment with opioid analgetics
- Hypersensitivity to naltrexone
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104
About this study
Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy as an antidissociative agent by using a double-blind randomized controlled trial.
Read the detailed description
Patients were randomized into two groups starting with either 3 weeks of 50 mg/d naltrexone or with 3 weeks of placebo. In either case the active treatment phases (weeks 1-6) were followed by one week of placebo. The major purpose of weeks 1-2 and 4-5, respectively, was to achieve a steady state during the active treatment. The primary comparisons of psychopathology under naltrexone and placebo refer to the weeks following the intended achievement of a steady state (weeks 3 and 6, respectively).
6 weeks of treatment were split into two phases: (A) 3 weeks of pharmacologically active treatment with naltrexone and (B) 3 weeks of pharmacologically inactive treatment with placebo (cross-over design). The sequence of the two treatment phases was randomized and concealed from both the patients and the health care professionals. In both cases, the last week ("Week 7") was without pharmacological intervention.
The primary outcome was based on the DSS, a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001) Mean scores for intensity (ranging from 0="no" to 9="very strong") and for duration (average time during which a particular symptom was present during the last 24 hours (in %)) were calculated for (a) dissociation (calculated from 21 Likert type items) and of (b) aversive inner tension (one item).
- Conditions
- Borderline Personality Disorder, Dissociation
- Being tested
- Naltrexone, Placebo
- Keywords
- Borderline Personality Disorder, Dissociation, Naltrexone
- Medical subject headings
- Borderline Personality Disorder, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
50 mg/d Naltrexone will be administrated during three weeks.
PlaceboDrug
During 3 weeks of the study, Placebo will be administrated (daily)
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone-Placebo | Active comparator | In the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated. Receives: Drug: Naltrexone; Drug: Placebo |
| Placebo-Naltrexone | Placebo comparator | The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated. Receives: Drug: Naltrexone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dissociation Tension Scale (DSS), a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001)
Measured: Oct. 1998-Oct 2001
Secondary outcomes (2)
The number, the method, and the severity of non-suicidal self-injurious acts during the last week.
The number, method and the severity of non-suicidal self-injurious acts are documented at the end of each week.
Number and intensity of flashbacks during the last week.
The number and intensity of flashbacks are documented at the end of each week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startAug 1998
- Primary completionAug 2001
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- University of Freiburg
- Investigators
- Christian Schmahl, MD, Study chair, Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133301
- Sponsor's protocol ID
- Naltrexone-BPD
- Other IDs
- nal-diss-bpd
- Status last verified
- May 2010
- First submitted
- 17 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoffers-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 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT01133301
- Acronym / sponsor ID
- Naltrexone-BPD
- Conditions
- Borderline Personality Disorder, Dissociation
- Keywords
- Borderline Personality Disorder, Dissociation, Naltrexone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- University of Freiburg
- Study start
- Aug 1998
- Primary completion
- Aug 2001 (actual)
- Study completion
- Oct 2001 (actual)
- First posted
- 28 May 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.
Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy as an antidissociative agent by using a double-blind randomized controlled trial.
Detailed description
Patients were randomized into two groups starting with either 3 weeks of 50 mg/d naltrexone or with 3 weeks of placebo. In either case the active treatment phases (weeks 1-6) were followed by one week of placebo. The major purpose of weeks 1-2 and 4-5, respectively, was to achieve a steady state during the active treatment. The primary comparisons of psychopathology under naltrexone and placebo refer to the weeks following the intended achievement of a steady state (weeks 3 and 6, respectively).
6 weeks of treatment were split into two phases: (A) 3 weeks of pharmacologically active treatment with naltrexone and (B) 3 weeks of pharmacologically inactive treatment with placebo (cross-over design). The sequence of the two treatment phases was randomized and concealed from both the patients and the health care professionals. In both cases, the last week ("Week 7") was without pharmacological intervention.
The primary outcome was based on the DSS, a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001) Mean scores for intensity (ranging from 0="no" to 9="very strong") and for duration (average time during which a particular symptom was present during the last 24 hours (in %)) were calculated for (a) dissociation (calculated from 21 Likert type items) and of (b) aversive inner tension (one item).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone-Placebo | Active comparator | Drug: Naltrexone, Drug: PlaceboIn the first three weeks of the study, 50 mg Naltrexone will be administrated, the following three three weeks placebo will be administrated. |
| Placebo-Naltrexone | Placebo comparator | Drug: Naltrexone, Drug: PlaceboThe first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of BPD according to DSM-IV
- DES score ≥ 18
- Female gender
- Age between 18 and 50 years
Key exclusion criteria (10 listed)
- Lifetime diagnosis of schizophrenia, psychotic or delusional disorder
- Current major depressive episode
- Lifetime diagnosis opioid dependence
- Current diagnosis opioid abuse
- Liver insufficiency or hepatitis
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 |
|---|---|---|
| Naltrexone50 mg/d Naltrexone will be administrated during three weeks. | Drug | Naltrexone-Placebo, Placebo-Naltrexone |
| PlaceboDuring 3 weeks of the study, Placebo will be administrated (daily) | Drug | Naltrexone-Placebo, Placebo-Naltrexone |
Primary outcome
Dissociation Tension Scale (DSS), a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001)
Time frame: Oct. 1998-Oct 2001
2 secondary outcomes
The number, the method, and the severity of non-suicidal self-injurious acts during the last week.
Number and intensity of flashbacks during the last week.
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 28 May 2010.
- 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.
Christian Schmahl, MD study chair
Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Borderline Personality Disorder and Dissociation, run by Central Institute of Mental Health, Mannheim 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 4 inclusion and 10 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 28 May 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Dissociation Tension Scale (DSS), a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001) (time frame: Oct. 1998-Oct 2001). 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 NCT01133301, which also lists 1 linked publication.
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 28 May 2010.