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Terminated Phase 3 Interventional Results available

Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

ClinicalTrials.gov ID: NCT01760993

Public ClinicalTrials.gov record NCT01760993. 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.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 3:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Long-term, Open-label, Multicenter, 52-week, Flexible-dose Safety Study of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Study identification

NCT ID
NCT01760993
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
2 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 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
Jan 31, 2013
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013
Last update posted
Jun 21, 2021

2013

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
SP Research PLLC/Oklahoma Clinical Research Center Oklahoma City Oklahoma 73112
CRI Lifetree Philadelphia Pennsylvania 19139

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 NCT01760993, 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 Jun 21, 2021 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01760993 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →