Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
Public ClinicalTrials.gov record NCT02360319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Cluster Randomized, Multi-center, Parallel-group, Rater-blind Study Comparing Treatment With Aripiprazole Once Monthly and Treatment as Usual on Effectiveness in First Episode and Early Phase Illness in Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this project is to show that the best possible option for preventing relapses in patients suffering from first episode (\<1 year of anti-psychotic medication) or early phase (\< 5 years of lifetime exposure to anti-psychotic medication) schizophrenia is by enhancing medication adherence. The study is designed to answer the question of whether the use of long-acting injectable (LAI) antipsychotics early in the course of treatment can break the cycle of frequent relapse that affects so many patients with early phase schizophrenia. The participating research sites (not individual patients) will be randomly assigned to either medication prescribed by their treating physician (with no restrictions) or to a regimen that involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one to one basis to either of the arms taking into account types of patient population and geographical area. Patients enrolled in the study will participate in regular assessments either over the phone or in person and be followed for a period of 2 years. The primary outcome measure is time to first hospitalization.
Study identification
- NCT ID
- NCT02360319
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 489 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 35 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2014 (Actual)
- Primary completion
- Mar 31, 2019 (Actual)
- Completion
- Mar 31, 2019 (Actual)
- Last update posted
- Dec 2, 2020
2014 – 2019
United States locations
- U.S. sites
- 39
- U.S. states
- 18
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| La Frontera | Tucson | Arizona | 85713 | — |
| San Fernando Mental Health Center | Granada Hills | California | 91344 | — |
| Stanford School of Medicine | Palo Alto | California | 94304 | — |
| Henderson Behavioral Health | Fort Lauderdale | Florida | 33319 | — |
| Meridian Behavioral Healthcare | Gainesville | Florida | 32614 | — |
| U. of Florida College of Medicine | Jacksonville | Florida | 32209 | — |
| LifeStream Behavioral Center | Leesburg | Florida | 34749 | — |
| Suncoast Center | St. Petersburg | Florida | 33711 | — |
| Apalachee Center, Inc. | Tallahassee | Florida | 32308 | — |
| Jerome Golden Center for Behavioral Health | West Palm Beach | Florida | 33407 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Chestnut Health Systems | Granite City | Illinois | 62040 | — |
| University of Iowa Psychiatry Research | Iowa City | Iowa | 52242 | — |
| Corrigan Mental Health Center | Fall River | Massachusetts | 02720 | — |
| U. Mass Medical School | Worcester | Massachusetts | 01605 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Early Treatment and Cognitive Health | East Lansing | Michigan | 48823 | — |
| Cherry Street Health Services | Grand Rapids | Michigan | 49503 | — |
| WMU School of Medicine | Kalamazoo | Michigan | 49048 | — |
| Community Mental Health for Central Michigan | Mount Pleasant | Michigan | 48858 | — |
| Muskegon County Community Mental Health | Muskegon | Michigan | 49433 | — |
| Saint Louis University CRU | St Louis | Missouri | 63104 | — |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | — |
| Creighton University | Omaha | Nebraska | 68131 | — |
| The Mental Health Center of Greater Manchester | Manchester | New Hampshire | 03101 | — |
| Healthy Perspectives | Nashua | New Hampshire | 03060 | — |
| New Bridge Medical Center | Paramus | New Jersey | 07652 | — |
| Carolina Behavioral Care | Durham | North Carolina | 27704 | — |
| Central Community Health Board of Hamilton Co. | Cincinnati | Ohio | 45219 | — |
| The Counseling Center of Wayne and Holmes Counties | Wooster | Ohio | 44691 | — |
| PeaceHealth Medical Group | Eugene | Oregon | 97401 | — |
| Carey Counseling Center | Huntingdon | Tennessee | 38344 | — |
| Spindletop Center | Beaumont | Texas | 77701 | — |
| Baylor College of Medicine | Houston | Texas | 77054 | — |
| MHC Community Healthcore | Longview | Texas | 75601 | — |
| The Center for Health Care Services | San Antonio | Texas | 78201 | — |
| Psychiatric & Behavioral Solutions | Salt Lake City | Utah | 84105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02360319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 2, 2020 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02360319 live on ClinicalTrials.gov.