Clinical Trial: Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial
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.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: 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 ]
Original Primary Outcome: To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms
Current Secondary Outcome: 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 ]
Original Secondary Outcome: To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD
Information By: AstraZeneca
Dates:
Date Received: November 15, 2005
Date Started: June 2004
Date Completion:
Last Updated: June 9, 2009
Last Verified: June 2009
