Efficacy and tolerability of asenapine compared with olanzapine in borderline personality disorder: a randomized controlled trial

Phase 4

Recruiting

• Conditions: Borderline personality disorder; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12614000551695
• Lead Sponsor: Centre for Personality Disorders, Psychiatric Clinic, Department of Neuroscience, University of Turin, Italy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Diagnosis of borderline personality disorder

Exclusion Criteria

Dementia, delirium and other cognitive disorders; schizophrenia and other psychotic disorders. Lifetime bipolar disorders. Concurrent major depressive episode. Substance abuse in the last two months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global symptoms assessed with the Clinical Global Impression Scale (CGI-S)[At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks]

Secondary Outcome Measures

Name	Time	Method
Specific borderline symptomatology measured with the Borderline Personality Disorder Severity Index (BPDSI)[At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks];Impulsivity assessed with the Barratt Impulsiveness Scale-version 11 (BIS-11)[At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks];Aggressiveness measured with the Modified Overt Aggression Scale (MOAS)[At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks];Self injurious behaviors assessed with the Self-Harm Inventory (SHI)[At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks];Affective symptoms measured with the Hamilton Scales for depression and anxiety (HAM-D) and (HAM-A)[At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks];Interpersonal functioning measured with the Social and Occupational Funcioning Assessing Scale (SOFAS)[At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks];Side effects of the drugs assessed with the Dosage Record and Treatment Emergent Symptoms Scale (DOTES)[At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks]