Naltrexone in Borderline Personality Disorder

Central Institute of Mental Health, Mannheim

Status and phase: Terminated; Phase 3

Conditions: Borderline Personality Disorder

Treatments: Drug: Naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT00124839

Naltrexon-BPS

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Pregnancy and lactation period
• Other severe medical or neurological diseases
• Simultaneous participation in another study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups

1

Other group

Description:

Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week)

Treatment:

Drug: Naltrexone

2

Other group

Description:

Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week)

Treatment:

Drug: Naltrexone

3

Other group

Description:

Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week)

Treatment:

Drug: Naltrexone

4

Other group

Description:

Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week)

Treatment:

Drug: Naltrexone