NCT02357849 (FACT) is a Phase 4 clinical trial of Aripiprazole in Attenuated Psychosis Syndrome, sponsored by Northwell Health.

Who is sponsoring NCT02357849?

NCT02357849 is sponsored by Northwell Health.

What drugs are being tested in NCT02357849?

Interventions in NCT02357849: Aripiprazole, Fluoxetine.

What condition does NCT02357849 study?

NCT02357849 studies Attenuated Psychosis Syndrome.

Is NCT02357849 still recruiting?

NCT02357849 is currently terminated. Last updated 27 October 2023.

Are results published for NCT02357849?

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

Last reviewed 2023-10-27 · How we verify

NCT02357849: FACT

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

The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Terminated Phase 4 Results posted Last updated 27 October 2023

What this trial tests

Phase 4 trial testing Aripiprazole in Attenuated Psychosis Syndrome in 9 participants. Terminated before completion.

Timeline

1 July 2014

Primary endpoint
4 April 2022

4 April 2022

Quick facts

Lead sponsor	Northwell Health
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	9
Start date	1 July 2014
Primary completion	4 April 2022
Estimated completion	4 April 2022
Sites	1 location across United States

Drugs / interventions tested

Aripiprazole (aripiprazole) — full drug profile →
Fluoxetine (fluoxetine) — full drug profile →

Conditions studied

Attenuated Psychosis Syndrome — all drugs for Attenuated Psychosis Syndrome →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 12 to 25, any sex, with Attenuated Psychosis Syndrome. 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.

Time to Treatment Failure
Time frame: 24 weeks
Time to either all-cause-discontinuation or need to add another psychotropic agent

Sponsor's own description

We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Preventive Treatments for Psychosis: Umbrella Review (Just the Evidence).
Fusar-Poli P, Davies C, Solmi M, Brondino N, et al · · 2019 · cited 84× · PMID 31920732 · DOI 10.3389/fpsyt.2019.00764

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 Northwell Health trials

Trials by the same sponsor.

NCT07253662 — Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Aden · Phase 1 · recruiting
NCT07191041 — Emotional Urinary Tract Infection · not yet recruiting
NCT07254091 — Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Pancreatic Cancer · EARLY_PHASE1 · recruiting
NCT07344961 — Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB) · recruiting
NCT07193862 — Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Meta · EARLY_PHASE1 · recruiting

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 NCT02357849 (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 Northwell Health
Last refreshed: 27 October 2023

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/NCT02357849.

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