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Trial registered on ANZCTR


Trial ID
ACTRN12614000551695
Ethics application status
Approved
Date submitted
12/05/2014
Date registered
22/05/2014
Date last updated
22/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and tolerability of asenapine compared with olanzapine in borderline personality disorder: a randomized controlled trial
Scientific title
Asenapine versus olanzapine in the treatment of impulsivity, aggression, and self injuries in patients with borderline personality disorder.
Secondary ID [1] 283436 0
Nil
Universal Trial Number (UTN)
U1111-1149-4071
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 290348 0
Condition category
Condition code
Mental Health 290745 290745 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to two arms of treatment: 1) asenapine (dose range: 5-10 mg/day) or 2) olanzapine (dose range: 5-10 mg/day). All drugs will be administered daily as oral tablets. The two drugs will be titrated (for the first three days at the dose of 5 mg/day and after at the dose if 10 mg/day, if side effects do not appear). The duration of treatment will be 12 weeks.
To monitor compliance to therapy we will check drug tablet return and we will ask, when available, the cooperation of a caregiver.
Intervention code [1] 288156 0
Treatment: Drugs
Comparator / control treatment
olanzapine at the dose of 5-10 mg/day
Control group
Active

Outcomes
Primary outcome [1] 290745 0
Global symptoms assessed with the Clinical Global Impression Scale (CGI-S)
Timepoint [1] 290745 0
At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks
Secondary outcome [1] 305149 0
Specific borderline symptomatology measured with the Borderline Personality Disorder Severity Index (BPDSI)
Timepoint [1] 305149 0
At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks
Secondary outcome [2] 305150 0
Impulsivity assessed with the Barratt Impulsiveness Scale-version 11 (BIS-11)
Timepoint [2] 305150 0
At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks
Secondary outcome [3] 305151 0
Aggressiveness measured with the Modified Overt Aggression Scale (MOAS)
Timepoint [3] 305151 0
At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks
Secondary outcome [4] 305152 0
Self injurious behaviors assessed with the Self-Harm Inventory (SHI)
Timepoint [4] 305152 0
At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks
Secondary outcome [5] 305153 0
Affective symptoms measured with the Hamilton Scales for depression and anxiety (HAM-D) and (HAM-A)
Timepoint [5] 305153 0
At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks
Secondary outcome [6] 305154 0
Interpersonal functioning measured with the Social and Occupational Funcioning Assessing Scale (SOFAS)
Timepoint [6] 305154 0
At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks
Secondary outcome [7] 305155 0
Side effects of the drugs assessed with the Dosage Record and Treatment Emergent Symptoms Scale (DOTES)
Timepoint [7] 305155 0
At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks

Eligibility
Key inclusion criteria
Diagnosis of borderline personality disorder
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5532 0
Italy
State/province [1] 5532 0

Funding & Sponsors
Funding source category [1] 288156 0
University
Name [1] 288156 0
Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, Italy
Address [1] 288156 0
Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, Via Cherasco 11, 10126 Turin, Italy
Country [1] 288156 0
Italy
Primary sponsor type
University
Name
Centre for Personality Disorders, Psychiatric Clinic, Department of Neuroscience, University of Turin, Italy
Address
Centre for Personality Disorders, Psychiatric Clinic, Department of Neuroscience, University of Turin, Via Cherasco, 11, 10126 Turin, Italy
Country
Italy
Secondary sponsor category [1] 286878 0
None
Name [1] 286878 0
None
Address [1] 286878 0
Country [1] 286878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290072 0
Comitato Etico interaziendale A.O.U. SAN GIOVANNI BATTISTA DI TORINO, A.O. C.T.O./ MARIA ADELAIDE DI TORINO
Ethics committee address [1] 290072 0
Corso Bramante 88/90 10126, Turin
Ethics committee country [1] 290072 0
Italy
Date submitted for ethics approval [1] 290072 0
25/10/2013
Approval date [1] 290072 0
20/01/2014
Ethics approval number [1] 290072 0
0005565

Summary
Brief summary
To date, only one open label trial on asenapine in the treatment of borderline personality disorder (BPD) is available. This study is aimed to test the efficacy and tolerability of asenapine compared with olanzapine (a widely studied antipsychotic in treatment of BPD). We will recruit consecutive patients with diagnosis of BPD. Patients will be randomly assigned to two arms of treatment: (1) asenapine (5-10 mg(day) or (2) olanzapine (5-10 mg/day). The trial duration will be 12 weeks. All participants will be tested at baseline, and after 6 and 12 weeks with the following instruments: the Clinical Global Impression Scale (CGI-S); the Borderline Personality Disorder Severity Index (BPDSI); the Barratt Impulsiveness Scale - version 11 (BIS-11); the Modified Overt Aggression Scale (MOAS); the Self-Harm Inventory (SHI); the Social and Occupational Functioning Assessment Scale (SOFAS); and the Dosage Record and Treatment Emergent Symptom Scale (DOTES).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43786 0
Prof Silvio Bellino
Address 43786 0
Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
Country 43786 0
Italy
Phone 43786 0
+39 011-6634848
Fax 43786 0
+39 011-673473
Email 43786 0
silvio.bellino@unito.it
Contact person for public queries
Name 43787 0
Prof Silvio Bellino
Address 43787 0
Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
Country 43787 0
Italy
Phone 43787 0
+39 0116634848
Fax 43787 0
+39 011673473
Email 43787 0
silvio.bellino@unito.it
Contact person for scientific queries
Name 43788 0
Dr Paola Bozzatello
Address 43788 0
Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
Country 43788 0
Italy
Phone 43788 0
+39 011665425
Fax 43788 0
+39 011673473
Email 43788 0
paola.bozzatello@unito.it