NCT03487770 is a Phase 3 clinical trial of Aripiprazole Oral Solution in Autistic Disorder, sponsored by Otsuka Beijing Research Institute.

Who is sponsoring NCT03487770?

NCT03487770 is sponsored by Otsuka Beijing Research Institute.

What drugs are being tested in NCT03487770?

Interventions in NCT03487770: Aripiprazole Oral Solution, Placebo Oral Solution.

What condition does NCT03487770 study?

NCT03487770 studies Autistic Disorder.

Is NCT03487770 still recruiting?

NCT03487770 is currently completed. Last updated 29 December 2020.

Last reviewed 2020-12-29 · How we verify

NCT03487770

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder

Completed Phase 3 Last updated 29 December 2020

What this trial tests

Phase 3 trial testing Aripiprazole Oral Solution in Autistic Disorder in 111 participants. Completed in 21 April 2020.

Timeline

9 April 2018

Primary endpoint
21 April 2020

21 April 2020

Quick facts

Lead sponsor	Otsuka Beijing Research Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	111
Start date	9 April 2018
Primary completion	21 April 2020
Estimated completion	21 April 2020
Sites	1 location across China

Drugs / interventions tested

Aripiprazole Oral Solution
Placebo Oral Solution

Conditions studied

Autistic Disorder — all drugs for Autistic Disorder →

Sponsor

Otsuka Beijing Research Institute

Who can join

Adults 6 to 17, any sex, with Autistic Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Impact of antipsychotics in children and adolescents with autism spectrum disorder: a systematic review and meta-analysis.
D'Alò GL, De Crescenzo F, Amato L, Cruciani F, et al · · 2021 · cited 26× · PMID 33494757 · DOI 10.1186/s12955-021-01669-0
Atypical antipsychotics for autism spectrum disorder: a network meta-analysis.
Meza N, Franco JV, Sguassero Y, Núñez V, et al · · 2025 · cited 8× · PMID 40396498 · DOI 10.1002/14651858.cd014965.pub2

Verify or expand the search:

Other recruiting trials for Autistic Disorder

Currently open trials in the same condition.

NCT05910502 — Project AFECT (Autism Family Empowerment Coaching and Training Program) · NA · active not recruiting
NCT06227780 — Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders · NA · recruiting
NCT05176808 — Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD) · NA · recruiting

Other Otsuka Beijing Research Institute trials

Trials by the same sponsor.

NCT06091267 — PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes · Phase 1, PHASE2 · active not recruiting
NCT05923892 — Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type · Phase 2 · completed
NCT05650320 — To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD · Phase 3 · completed
NCT05667623 — To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD · Phase 3 · completed
NCT07105124 — Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03487770 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Beijing Research Institute
Last refreshed: 29 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03487770.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing