NCT01133301

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 1998

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
Last Updated

May 28, 2010

Status Verified

May 1, 2010

Enrollment Period

3 years

First QC Date

May 17, 2010

Last Update Submit

May 26, 2010

Conditions

Borderline Personality DisorderDissociation

Keywords

Borderline Personality DisorderDissociationNaltrexone

Outcome Measures

Primary Outcomes (1)

  • 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)

    Oct. 1998-Oct 2001

Secondary Outcomes (2)

  • 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.

Study Arms (2)

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.

Drug: NaltrexoneDrug: Placebo

Placebo-Naltrexone

PLACEBO COMPARATOR

The first three weeks, placebo will be administrated, the following three weeks 50 mg Naltrexone will be administrated.

Drug: NaltrexoneDrug: Placebo

Interventions

NaltrexoneDRUG

50 mg/d Naltrexone will be administrated during three weeks.

Naltrexone-PlaceboPlacebo-Naltrexone
PlaceboDRUG

During 3 weeks of the study, Placebo will be administrated (daily)

Naltrexone-PlaceboPlacebo-Naltrexone

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of BPD according to DSM-IV
  • DES score ≥ 18
  • Female gender
  • Age between 18 and 50 years

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36375174DERIVED

MeSH Terms

Conditions

Borderline Personality DisorderDissociative Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Christian Schmahl, MD

    Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 28, 2010

Study Start

August 1, 1998

Primary Completion

August 1, 2001

Study Completion

October 1, 2001

Last Updated

May 28, 2010

Record last verified: 2010-05

Locations

DE(1)