ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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]

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

Condition category

Condition code

Mental Health

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]

Treatment: Drugs

Comparator / control treatment

olanzapine at the dose of 5-10 mg/day

Control group

Active

Outcomes

Primary outcome [1]

Global symptoms assessed with the Clinical Global Impression Scale (CGI-S)

Timepoint [1]

At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks

Secondary outcome [1]

Specific borderline symptomatology measured with the Borderline Personality Disorder Severity Index (BPDSI)

Timepoint [1]

At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks

Secondary outcome [2]

Impulsivity assessed with the Barratt Impulsiveness Scale-version 11 (BIS-11)

Timepoint [2]

At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks

Secondary outcome [3]

Aggressiveness measured with the Modified Overt Aggression Scale (MOAS)

Timepoint [3]

At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks

Secondary outcome [4]

Self injurious behaviors assessed with the Self-Harm Inventory (SHI)

Timepoint [4]

At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks

Secondary outcome [5]

Affective symptoms measured with the Hamilton Scales for depression and anxiety (HAM-D) and (HAM-A)

Timepoint [5]

At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks

Secondary outcome [6]

Interpersonal functioning measured with the Social and Occupational Funcioning Assessing Scale (SOFAS)

Timepoint [6]

At baseline (T0) and after 6 (T1/2) and 12 (T1) weeks

Secondary outcome [7]

Side effects of the drugs assessed with the Dosage Record and Treatment Emergent Symptoms Scale (DOTES)

Timepoint [7]

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

Sex

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

19/05/2014

Actual

19/05/2014

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

80

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, Italy

Address [1]

Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, Via Cherasco 11, 10126 Turin, Italy

Country [1]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comitato Etico interaziendale A.O.U. SAN GIOVANNI BATTISTA DI TORINO, A.O. C.T.O./ MARIA ADELAIDE DI TORINO

Ethics committee address [1]

Corso Bramante 88/90 10126, Turin

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

25/10/2013

Approval date [1]

20/01/2014

Ethics approval number [1]

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

Prof Silvio Bellino

Address

Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.

Country

Italy

Phone

+39 011-6634848

Fax

+39 011-673473

Email

[email protected]

Contact person for public queries

Name

Silvio Bellino

Address

Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.

Country

Italy

Phone

+39 0116634848

Fax

+39 011673473

Email

[email protected]

Contact person for scientific queries

Name

Paola Bozzatello

Address

Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.

Country

Italy

Phone

+39 011665425

Fax

+39 011673473

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy and Tolerability of Asenapine Compared with Olanzapine in Borderline Personality Disorder: An Open-Label Randomized Controlled Trial.	2017	https://dx.doi.org/10.1007/s40263-017-0458-4

N.B. These documents automatically identified may not have been verified by the study sponsor.