Pharmacotherapy, Schizophrenia and Related Disorders, Stimulant Abuse, Stimulant Dependence, Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis)
Conditions
Keywords
stimulant, psychosis, schizophrenia, dependence, pharmacotherapy
Brief summary
In Hong Kong, less than 5% of stimulants abusers were reported to misuse these substances via injection. Also, it is well known that patients with co-morbid substance abuse/dependence and psychosis or schizophrenia-related disorders are prone to earlier treatment discontinuation and high oral medication non-adherence, resulting in poorer overall outcomes. With the recent availabilities of the 4-weekly long-acting injectable form of aripiprazole, and the 4-weekly and the 3-monthly long-acting injectable form of paliperidone palmitate, on the background of the surging phenomenon of stimulant misuses in Hong Kong, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with substance use disorders with psychosis to develop into a more chronic disabling dependence or co-morbid state.
Interventions
DRUGAripiprazole
for oral or depot preparation
DRUGPaliperidone
for oral or depot
OTHERTreatment as Usual
to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone
Sponsors
The University of Hong Kong
Queen Mary Hospital, Hong Kong
North District Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
treatment group randomised to each participant is masked to the outcome assessors
Intervention model description
prospective randomised single-blinded
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
• Stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis
Exclusion criteria
* Age \<16 years old * Unable to read English or Chinese * Unable to give informed consent * Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10 F70-73) * Had been diagnosed to have Schizophrenia * Had been diagnosed to have other substance-induced psychotic or mood disorder, including alcohol * Had been diagnosed to have bipolar disorder viii. Had been diagnosed to have major depressive disorder with psychotic features * Had been taking any maintenance dose of oral antipsychotics continuously ≥12 weeks AND with psychotic symptoms in remission * Had been receiving any maintenance dose of long-acting injectable (LAI/depot) antipsychotics continuously ≥4 month AND with psychotic symptoms in remission * Had known hypersensitivity to risperidone (oral or LAI), paliperidone (oral or LAI), or aripiprazole (oral or LAI) * Had known history of tardive dyskinesia * Had known history of neuroleptic malignant syndrome * Pregnant * Mother currently breast-feeding * Had history of prolonged corrected QT interval (QTc) ≥500ms and/or known unstable or untreated cardiac disorder * Had mild to severe renal impairment with Glomerular Filtration Rate \<80 mililitre /min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy on psychosis management as measured by the Clinical Global Impression | at 12th and at 24th months | The efficacy for managing stimulant associated psychosis for subjects receiving the active treatments with aripiprazole and paliperidone as compared to treatment-as-usual is measured by the Clinical Global Impression (CGI). The Clinical global impression consists of 3 components: CGI-severity (CGI-S), CGI-Improvement (CGI-I) and CGI-efficacy (CGI-E). CGI-S and CGI-I are both 7-point item, ranging from 0 (normal) to 7 (severely ill) and 0 (very much improved) to 7 (very much worse), respectively. The CGI-efficacy is the composite measured of its therapeutic effect and side effects, with scoring ranging from 1 (marked therapeutic effect) to 16 (unchanged with side effects outweighed therapeutic effects). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5 | 24 months | The rate of transition from substance induced psychosis To schizophrenia in all 3 different arms |
| Efficacy on psychosis symptom control as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24) | at 12th and at 24th months | The efficacy for controlling symptoms of stimulant associated psychosis for subjects receiving the active treatments with paliperidone and aripiprazole as compared to treatment as usual is measured by BPRS. The lowest score of BPRS-24 is 24. The lower the score of BPRS refers to better efficacy in controlling psychosis symptoms. |
| change in stimulant use disorder as defined by DSM-5 | At 12th month and at 24th month | The change is severity of the Stimulant Use Disorder in subjects in the 3 different arms by DSM-5 criteria |
| Montreal Cognitive Assessment (MoCA) | At 12th month and at 24th month | Difference in cognitive outcome measured using MoCA in subjects randomized to the 3 arms. MoCA has the maximum score of 30. A cut-off score of higher than or equal to 26 refers to normal cognition. |
| Addiction Severity Index (ASL)-lite | At 12th and 24th months | Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORalbert KK Chung, Dr
The University of Hong Kong
Outcome results
None listed