Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients

Study Overview
=================
Brief Summary
-----------------
In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far as the investigators know, no well designed controlled studies have been performed on the effect of one of the newer atypical antipsychotics on psychotic symptoms. It is of interest to investigate the benefit of quetiapine treatment in these types of patients. Quetiapine possibly gives less side-effects because of the expected lack of elevated prolactin levels, which is of importance in this patient group, overrepresented by young females. In this double blind, randomized, placebo controlled, 8 week, parallel group, multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be compared with the placebo.

Official Title
-----------------
The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with BPD according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)/Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) including criterion 9: transient, stress related paranoid ideation or severe dissociative symptoms. In- or outpatients Exclusion Criteria: Depressive disorder Bipolar disorder Schizoaffective disorder/schizophrenia/delusional disorder/schizotypal personality disorder Alcohol- or substance dependence Quetiapine doses >100mg od use in the past Somatic: History of trauma capitis Visual and auditive disorders Neurological disorders (epilepsy) Pregnancy No adequate contraception History of cardial complaints/cardiological disorder Known sensitivity for quetiapine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* placebo<br>|
| Experimental: 2<br>Flexible doses of 200 mg/day to 600 mg/day quetiapine fumarate | Drug: Quetiapine fumarate<br>* flexible doses from 200 mg to 600 mg<br>* Other names: 204,636;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms |  | assessed at each visit for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD |  | assessed at each visit for 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Borderline personality disorder