A Phase 2/3 interventional study of Aripiprazole and Paliperidone in Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis), Schizophrenia and Related Disorders and Stimulant Dependence, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by The University of Hong Kong · Phase 2/3, Interventional, and Treatment
Among 126 studies testing aripiprazole in Schizophrenia — 4 open to participants now, 4 under way, 1 of them phase 3. Aripiprazole · Schizophrenia.
Among the 126 studies testing aripiprazole in Schizophrenia, this one is the 56th largest by enrollment of the 125 interventional ones, is one of 6 that started in 2019, is one of 4 in phase 2/3, and was the 110th registered.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 165 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →4 of the 126 studies testing aripiprazole in Schizophrenia are open now, in 2 countries. Each count lists the studies.
Aripiprazole: first FDA approval 2002 (ABILIFY), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 16 Years to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →126 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 6 started in 2019.
Median enrollment 130 across the 125 interventional studies. Of the 105 that completed or were terminated, 47 (45%) have results posted.
66 of 126 have an industry lead sponsor. The 10 most frequent:
The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
12 studies in Schizophrenia by The University of Hong Kong: 1 open now, 1 under way, none of them phase 3. Of 9 finished, 0 (0%) have results posted.
Among the 12 studies in Schizophrenia by The University of Hong Kong, this one is one of 2 that started in 2019, is one of 2 in phase 2/3, and was the 7th registered.
The University of Hong Kong’s Schizophrenia studies by the year they started, since 2003.
1 of the studies testing aripiprazole in Schizophrenia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07547384CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia. | 2027-09-05 |
Among the 126 studies testing aripiprazole in Schizophrenia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among The University of Hong Kong’s 12 in Schizophrenia:
Nothing recorded among them since 2026-09-25.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 165 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Schizophrenia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aripiprazole (oral or depot) Oral: 10-30mg daily Depot: 300-400mg every four week; Intramuscularly
Drug: Aripiprazole
Paliperidone (oral or depot) Oral: 3-12mg Depot: Intramuscularly; a) sustenna 50-150mg every four weekly, or b) trinza 273-819mg every 12 weekly
Drug: Paliperidone
Treatment as Usual arm
Other: Treatment as Usual
for oral or depot preparation
for oral or depot
to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone
Efficacy on psychosis management as measured by the Clinical Global Impression
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).
Time frame: at 12th and at 24th months
transition from diagnosis of substance induced psychosis to Schizophrenia as defined by DSM-5
The rate of transition from substance induced psychosis To schizophrenia in all 3 different arms
Time frame: 24 months
Efficacy on psychosis symptom control as measured by the Brief Psychiatric Rating Scale - 24 items (BPRS-24)
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.
Time frame: at 12th and at 24th months
change in stimulant use disorder as defined by DSM-5
The change is severity of the Stimulant Use Disorder in subjects in the 3 different arms by DSM-5 criteria
Time frame: At 12th month and at 24th month
Montreal Cognitive Assessment (MoCA)
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.
Time frame: At 12th month and at 24th month
Addiction Severity Index (ASL)-lite
Difference in functional outcome measured using ASL-lite in subjects randomized to the 3 treatment arms
Time frame: At 12th and 24th months
Ran from Jun 2019 to primary completion in May 2024, 59 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Aripiprazole · Paliperidone