Borderline Personality Disorder Clinical Trial
Official title:
Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
Active, not recruiting |
NCT04587518 -
Five Factor Model Treatment for Borderline Personality Disorder
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Completed |
NCT03677037 -
The Short-Term MBT Project
|
Phase 3 | |
Not yet recruiting |
NCT05989529 -
Delving Into Borderline Personality Disorder Clinical Trial Experiences
|
||
Completed |
NCT02518906 -
Evaluation of AIT Study
|
N/A | |
Completed |
NCT02068326 -
MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A | |
Completed |
NCT02108990 -
Acetaminophen and Social Processes
|
Phase 2 | |
Terminated |
NCT02149823 -
Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
|
Phase 1 | |
Completed |
NCT01635556 -
Evaluation of a Modified Dialectical Behavior Therapy Program
|
N/A | |
Not yet recruiting |
NCT01683136 -
Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder
|
N/A | |
Completed |
NCT02988037 -
Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study
|
N/A | |
Completed |
NCT02397031 -
Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
|
N/A | |
Terminated |
NCT01103180 -
Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder
|
Phase 2 | |
Terminated |
NCT01212588 -
Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD)
|
Phase 2 | |
Terminated |
NCT00539188 -
N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD
|
Phase 2 | |
Recruiting |
NCT05398627 -
Neurofeedback for Borderline Personality Disorder
|
N/A | |
Recruiting |
NCT03994510 -
SHame prOpensity in bOrderline Personality Disorder
|
N/A | |
Recruiting |
NCT06005129 -
Personality Change Study for Borderline Personality Disorder
|
N/A |