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

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 .... 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 Week 39 – aripiprazole prescribed at discretion of treating team. At any stage, a dose may be reduced or an increment postponed at the discretion of the treating team, in consultation with the investigator(s). If a break in pharmacotherapy occurs, the participant may be recommenced on the investigational product, with the restarting dose at the discretion of the treating team, in consultation with the investigator(s). 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 be supported to program reminders in their phone calendar, a reminders app, or with a medication-reminder app. Most participants will receive weekly psychosocial treatment in the Helping Young People Early (HYPE) program at Orygen Youth Health, comprising general psychiatric care, clinical case management and may include up to 16 x 50-minute sessions of individual Cognitive Analytic Therapy. Treatment is provided by a multidisciplinary team including psychiatrists, clinical psychologists, social workers and occupational therapists and is delivered at Orygen Youth Health sites and in the community. Some participants might receive multidisciplinary treatment from other Orygen Youth Health programs or they might receive individual or multidisciplinary care from mental health services external to Orygen. The decision to provide treatment in other Orygen Youth Health programs or external services is based on Orygen Youth Health operational protocols. The treatment may include a combination of general psychiatric care, case management and/or individual psychotherapy, as indicated.
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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 .... 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 be supported to program reminders in their phone calendar, a reminders app, or with a medication-reminder app. Most participants will receive weekly psychosocial treatment in the Helping Young People Early (HYPE) program at Orygen Youth Health, comprising general psychiatric care, clinical case management and may include up to 16 x 50-minute sessions of individual Cognitive Analytic Therapy. Treatment is provided by a multidisciplinary team including psychiatrists, clinical psychologists, social workers and occupational therapists and is delivered at Orygen Youth Health sites and in the community. Some participants will receive psychosocial treatment from medical professionals in other Orygen Youth Health programs or from mental health services external to Orygen. The decision to provide treatment in other Orygen Youth Health programs or external services is based on Orygen Youth Health operational protocols. This treatment may include a combination of general psychiatric care, case management and/or individual psychotherapy, as indicated.
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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 intervention.