- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00254748
Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients
The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Apeldoorn, Netherlands
- Research Site
-
Nijmegen, Netherlands
- Research Site
-
Veghel, Netherlands
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Placebo
|
placebo
|
Experimental: 2
Flexible doses of 200 mg/day to 600 mg/day quetiapine fumarate
|
flexible doses from 200 mg to 600 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms
Time Frame: assessed at each visit for 8 weeks
|
assessed at each visit for 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD
Time Frame: assessed at each visit for 8 weeks
|
assessed at each visit for 8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1441C00003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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