NCT00216476 is a Phase 3 clinical trial of Aripiprazole in Schizophrenia, sponsored by Janssen-Cilag International NV.

Who is sponsoring NCT00216476?

NCT00216476 is sponsored by Janssen-Cilag International NV.

What drugs are being tested in NCT00216476?

Interventions in NCT00216476: Aripiprazole, Risperidone Long Acting Injectable (LAI), Quetiapine.

What condition does NCT00216476 study?

NCT00216476 studies Schizophrenia, Psychotic Disorders.

Is NCT00216476 still recruiting?

NCT00216476 is currently completed. Last updated 25 March 2014.

Are results published for NCT00216476?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-03-25 · How we verify

NCT00216476

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

CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness

Completed Phase 3 Results posted Last updated 25 March 2014

What this trial tests

Phase 3 trial testing Aripiprazole in Schizophrenia in 753 participants. Completed in 1 November 2007.

Timeline

1 October 2004

Primary endpoint
1 November 2007

1 November 2007

Quick facts

Lead sponsor	Janssen-Cilag International NV
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	753
Start date	1 October 2004
Primary completion	1 November 2007
Estimated completion	1 November 2007
Sites	96 locations across Austria, Bulgaria, Croatia, Czechia, Denmark, Estonia, France, Germany

Drugs / interventions tested

Aripiprazole (aripiprazole) — full drug profile →
Risperidone Long Acting Injectable (LAI) — full drug profile →
Quetiapine (quetiapine) — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →
Psychotic Disorders — all drugs for Psychotic Disorders →

Sponsor

Janssen-Cilag International NV — full company profile →

Who can join

18 and older, any sex, with Schizophrenia or Psychotic Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)
Time frame: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)
Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.

Sponsor's own description

The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner.

Publications & conference data

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

Relapse prevention in schizophrenia and schizoaffective disorder with risperidone long-acting injectable vs quetiapine: results of a long-term, open-label, randomized clinical trial.
Gaebel W, Schreiner A, Bergmans P, de Arce R, et al · · 2010 · cited 81× · PMID 20686456 · DOI 10.1038/npp.2010.111
Long-term remission in schizophrenia and schizoaffective disorder: results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE).
Smeraldi E, Cavallaro R, Folnegović-Šmalc V, Bidzan L, et al · · 2013 · cited 14× · PMID 24167692 · DOI 10.1177/2045125313479127
Depicting Risperidone Safety Profiles in Clinical Trials Across Different Diagnoses Using a Dopamine D<sub>2</sub>-Based Pharmacological Class Effect Query Defined by FAERS.
Hopkins SC, Ogirala A, Zeni C, Worden M, et al · · 2022 · cited 3× · PMID 36350559 · DOI 10.1007/s40261-022-01218-7

Verify or expand the search:

Other trials of Aripiprazole

Trials testing the same drug.

NCT06236451 — Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia · Phase 4 · completed
NCT06060886 — Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis · Phase 4 · unknown
NCT05554627 — VA Aripiprazole vs Esketamine for Treatment Resistant Depression · Phase 4 · withdrawn
NCT05814640 — Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) · Phase 1, PHASE2 · recruiting
NCT05322031 — The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia · Phase 4 · completed

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Janssen-Cilag International NV trials

Trials by the same sponsor.

NCT04940039 — A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings · Phase 4 · completed
NCT04338321 — A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selectiv · Phase 3 · completed
NCT03852160 — A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Stan · Phase 3 · withdrawn
NCT03947814 — A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment · Phase 1 · terminated
NCT03816631 — A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment · 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 NCT00216476 (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 Janssen-Cilag International NV
Last refreshed: 25 March 2014

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/NCT00216476.

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