Data

VERBATIM: A randomised controlled trial of aripiprazole for the treatment of auditory verbal hallucinations in borderline personality disorder

Orygen

Dataset description

This dataset originates from a 12-week, single-centre, randomized controlled trial (RCT) that examines the efficacy of aripiprazole versus placebo in treating auditory verbal hallucinations (AVHs) in 15-25 year-olds diagnosed with Borderline Personality Disorder (BPD). The study addresses a critical gap in clinical practice by testing conventional pharmacotherapy used for AVHs in schizophrenia, applied to similar symptoms in BPD, a practice not currently supported by NHMRC guidelines for BPD treatment. Participants were followed for a total of 27 weeks, with assessments on AVH severity, BPD symptoms, general psychopathology, functioning, and the experience of psychotic symptoms. The study also explored changes in the neurobiological mechanisms underlying AVHs as influenced by treatment.
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Subjects

FOR: Mental Health |

Source Study

Trial acronym

VERBATIM: VoicE Response in Borderline personality disorder to Aripiprazole TrIal Medication

Trial ID

ACTRN12616001192471

Purpose

Treatment

Phase

Phase 3

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Prof Andrew Chanen

Brief Summary

Borderline personality disorder (BPD) affects over 95,000 15-24 year-old Australians and is a leading cause disability and mortality in this age group. Up to half of patients with BPD experience distressing and disabling auditory verbal hallucinations (AVHs) but opinion about their veracity and their treatment is polarised. Second generation antipsychotic medications (SGAs) are prescribed frequently ‘off label’ for BPD, despite limited supporting evidence. Recent studies show that AVHs in BPD an ....
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Key Inclusion Criteria

(1) males and females aged 15-25 years inclusive; (2) ability to give informed consent and adhere to study procedures; (3) sufficient fluency in English; (4) Structured Clinical Interview for Diagnostic and Statistical Manual 5th Edition - Personality Disorders (SCID-5-PD) borderline personality disorder; (5) threshold auditory verbal hallucinations (5 or 6 on severity and 4 or more on frequency) for longer than one week within the past four weeks using ratings on the Comprehensive Assessment of ....
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Key Exclusion Criteria

(1) DSM-5 schizophreniform disorder, schizophrenia, schizoaffective disorder, psychotic disorder due to another medical condition, catatonia, delusional disorder, bipolar I disorder, or substance/medication induced psychotic disorder; (2) prior sensitivity or allergy to aripiprazole or formulation; (3) antipsychotic treatment for 4 weeks or more at a dose equal to or greater than 200 mg chlorpromazine equivalent within 8 weeks of study entry; (4) pregnancy, lactation, or if sexually active, no e ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    78

Min. age    15 Years

Max. age    25 Years

Sex    Both males and females

Condition category    Auditory verbal hallucinations , Borderline personality disorder

Condition code    Mental Health

Intervention

Intervention code Treatment: Drugs

Aripiprazole. Aripiprazole to be administered by oral tablet(s) in accordance with the following schedule: 2mg once daily in Week 1; 5mg once daily in Week 2; 10mg once daily in Week 3; Week 4 to Week 12 increments to 15mg once daily, 20mg once daily then 30mg once daily for participants who have persistent symptoms and can tolerate further dose escalation, at discretion of treating team, with at least a 1-week gap between dose increments. The maximum allowable dose will be 30mg/day; Week 13 to ....
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Comparison

Control group Placebo

Placebo. Placebo will be administered using the same dosing schedule as the aripiprazole intervention. Medication adherence will be monitored via capsule counts, recorded in returns to the Pharmacy and with the 10-item self-report Medication Adherence Rating Scale (Thompson, Kulkarni & Sergejew, 2000). At each study visit, participants will be reminded in person to take study medication and to return empty containers. Participants may also be assisted with SMS or phone call reminders. They may b ....
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Outcomes

Outcome: Change in severity of auditory verbal hallucinations as measured by the auditory hallucinations subscale of the Psychotic Symptom Rating Scales (PSYRATS: Drake et al, 2007).
Timepoint: 12 weeks post commencement of intervention (primary endpoint) compared with baseline, as well as 39 weeks post commencement of intervention (secondary endpoint) compared with baseline. The PSYRATS will also be administered 4 weeks and 8 weeks post commencment of inter ....

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Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All of the individual trial-related participant data collected during the trial, after de-identification.

When will data be available?

Immediately following publication and for an indefinite time.

Available to whom?

Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy.

Available for what types of analyses?

Any type of analyses. Assessed on a case-by-case basis.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au